Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36631   clinical trials with a EudraCT protocol, of which   6048   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-004201-33
    Sponsor's Protocol Code Number:IMMU-132-09
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-004201-33
    A.3Full title of the trial
    Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens
    Estudio en fase III de sacituzumab govitecan (IMMU-132) frente al tratamiento elegido por el médico (TEM) en pacientes con cáncer de mama metastásico (CMM) negativo para el receptor 2 del factor de crecimiento epidérmico humano (HER2) y positivo para el receptor hormonal (HR+) que no han respondido, como mínimo, a dos tratamientos quimioterapéuticos previos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare study medication Sacituzumab Govitecan to Standard of Care in Metastatic Breast Cancer which has progressed or returned after at least 2 prior treatments.
    Estudio que compara el medicamento del estudio sacituzumab govitecan frente al tratamiento habitual para cáncer de mama metastásico (CMM) que ha progresado o regresado después de, como mínimo, dos tratamientos previos.
    A.3.2Name or abbreviated title of the trial where available
    Phase 3 Study of Sacituzumab Govitecan (IMMU-132) in Relapsed/Refractory HR+/HER2- MBC
    Estudio en fase 3 de sacituzumab govitecan (IMMU-132) para CMM HR+/HER2 recidivo/refractario
    A.4.1Sponsor's protocol code numberIMMU-132-09
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03901339
    A.5.4Other Identifiers
    Name:INDNumber:122694
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorImmunomedics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportImmunomedics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunomedics, Inc.
    B.5.2Functional name of contact pointImmunomedics Medical Information
    B.5.3 Address:
    B.5.3.1Street Address300 The American Road
    B.5.3.2Town/ cityMorris Plains
    B.5.3.3Post codeNJ 07950
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1888983 4668
    B.5.6E-mailMedinfo@immunomedics.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSacituzumab govitecan
    D.3.2Product code IMMU-132, hRS7-SN38
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSACITUZUMAB GOVITECAN
    D.3.9.1CAS number 1491917-83-9
    D.3.9.2Current sponsor codeSacituzumab Govitecan
    D.3.9.3Other descriptive nameIMMU-132, hRS7-SN38
    D.3.9.4EV Substance CodeSUB191213
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Halaven
    D.2.1.1.2Name of the Marketing Authorisation holderEisai GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEribulin
    D.3.9.1CAS number 441045-17-6
    D.3.9.3Other descriptive nameERIBULIN MESYLATE
    D.3.9.4EV Substance CodeSUB31126
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.44
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCapecitabine
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.9.1CAS number 154361-50-9
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCapecitabine
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.9.1CAS number 154361-50-9
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gemcitabina Hospira 200 mg concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGemcitabine hydrochloride
    D.3.9.1CAS number 122111-03-9
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gemcitabina Hospira 1000 mg concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGemcitabine hydrochloride
    D.3.9.1CAS number 122111-03-9
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 7
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gemcitabina Hospira 2000 mg concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGemcitabine hydrochloride
    D.3.9.1CAS number 122111-03-9
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 8
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Navelbine
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE IBÉRICA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVinorelbine
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVINORELBINE
    D.3.9.1CAS number 71486-22-1
    D.3.9.4EV Substance CodeSUB00069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor
    Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC)
    Cáncer de mama metastásico (CMM) negativo para el receptor 2 del factor de crecimiento epidérmico humano (HER2) y positivo para el receptor hormonal (HR+)
    E.1.1.1Medical condition in easily understood language
    Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor
    Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who has progressed or returned
    Cáncer de mama metastásico (CMM) negativo para el receptor 2 del factor de crecimiento epidérmico humano (HER2) y positivo para el receptor hormonal (HR+) que ha progresado o regresado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006198
    E.1.2Term Breast cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess and compare efficacy of Sacituzumab Govitecan to treatment of physician’s choice (TPC) as measured by progression-free survival (PFS) (as determined by local investigator review [LIR] using Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST1.1]) in subjects with HR+/HER2- MBC after at least 2, and no more than 4, prior chemotherapy regimens for MBC.

    - To assess and compare objective (overall) response rate (ORR) between treatment arms as determined by blinded independent central review (BICR) using RECIST 1.1.
    -Evaluar y comparar la eficacia de sacituzumab govitecan con el tratamiento elegido por el médico (TEM) por medio de la medición de la supervivencia sin progresión (SSP) (determinado por la revisión del investigador local [RIL] utilizando los Criterios de evaluación de respuesta en tumores sólidos, versión 1.1 [RECIST1.1]) en sujetos con CMM HR+/HER2- después de cómo mínimo 2, y como mucho 4, tratamientos quimioterapéuticos anteriores para el CMM.
    E.2.2Secondary objectives of the trial
    - To assess and compare Sacituzumab Govitecan to TPC in overall survival (OS) in subjects with HR+/HER2- MBC after at least 2, and no more than 4, prior chemotherapy treatment regimens for MBC.
    - To assess and compare duration of response (DOR) and clinical benefit rate (CR+PR+SD with a duration of > 6 months) between treatment arms as determined by LIR using RECIST 1.1
    Please see protocol page 38 for the full list
    -Evaluar y comparar sacituzumab govitecan con el TEM en la supervivencia global (SG) en sujetos con CMM HR+/HER2- después de como mínimo 2, y como mucho 4, tratamientos quimioterapéuticos anteriores para el CMM.
    -Evaluar y comparar la duración de la respuesta (DDR) y la tasa de beneficio clínico (RC + RP + EE con una duración ≥ 6 meses) entre los grupos de tratamiento según lo determinado por RIL utilizando RECIST 1.1
    Véase la página 38 del protocolo para el listado completo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male subjects aged ≥18 years at the time of signing the informed consent form (ICF).
    2. Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed (local laboratory) with the most recently available or newly obtained tumor biopsy (within last 12 months) from a locally recurrent or metastatic site(s) and defined per ASCO/CAP criteria as: HR positive and HER2-negative.
    3. Availability of archival tumor tissue (within 12 months prior to randomization) or newly acquired biopsy from a metastatic site.
    4. Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC.
    5. Subjects should have been previously treated with:
    - Taxanes in any setting.
    - At least 1 prior anticancer hormonal treatment.
    - At least 1 cyclin-dependent kinase inhibitor 4/6 in the metastatic setting.
    6. Eligible for one of the chemotherapy options listed in the TPC arm.
    7. Documented disease progression after the most recent therapy.
    8. At least 1 measurable target lesion according to RECIST 1.1 (bony disease only is not allowed) meeting all of the following criteria:
    - Lymph node (LN) lesion that measures at least one dimension as ≥1.5 cm in the short axis.
    - Non-nodal lesion that measures ≥1.0 cm in the longest diameter.
    - The lesion is suitable for repeat measurement using CT/MRI.
    - Lesions that have had EBRT or locoregional therapy must show radiographic evidence of disease progression based on RECIST 1.1 to be deemed a target lesion.
    9. Brain MRI must be conducted for subjects with a history of brain metastasis. The subject must have had stable CNS disease for at least 4 weeks.
    10. Life expectancy of ≥3 months from randomization based on the PI’s assessment.
    11. ECOG performance status of 0 or 1
    12. Adequate renal function.
    13. Adequate bone marrow function
    Note: Blood transfusion or growth factor support is not allowed within 14 days prior to screening labs.
    14. Adequate liver function.
    15. Resolution of all systemic anticancer therapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (≤Grade 2) and alopecia. Subjects with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.
    16. Females must not be lactating or pregnant at Screening or Baseline test. A separate baseline assessment is required if a negative screening serum pregnancy test was obtained more than 72 hours before the first dose of study drug.
    - All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.
    17. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception throughout the entire study period and for 120 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 28 days before dosing and must continue to use the same contraceptive during the study and for 120 days after study drug discontinuation.
    18. Male subjects who are partners of women of childbearing potential must use a condom and spermicide and their female partners, must use a highly effective method of contraception beginning at least 1 menstrual cycle prior to starting study drug(s), throughout the entire study period, and for 6 months after the last dose of study drug, unless the male subjects are totally sexually abstinent or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile. No sperm donation is allowed during the study period or for 6 months after study drug discontinuation.
    19. Subject must be willing and able to comply with all aspects of the protocol.
    20. Subject must voluntarily agree to provide written informed consent.
    21. Subjects could have received an unlimited number of prior endocrine, biological, or targeted therapies (including taxanes and CD 4/6 inhibitors) in the absence of co-administered chemotherapy; all of these therapies must have been completed 14 days prior to randomization.
    1. Mujeres u hombres ≥18 años en el momento de la firma del formulario de consentimiento informado (FCI)
    2. Pruebas confirmadas de cáncer de mama metastásico con receptores hormonales positivos HER2-negativos
    (HR+/HER2-) (laboratorio local) con la biopsia tumoral más reciente disponible o recién obtenida (en los últimos 12 meses) de un sitio localmente recurrente o metastásico y definido según los criterios de ASCO/CAP como: HR positivo y HER2-negativo.
    3. Disponibilidad de tejido tumoral de archivo (en los 12 meses previos a la aleatorización) o una biopsia recientemente adquirida de un sitio metastásico.
    4. Resistente o recidivante después de al menos 2, y no más de 4, tratamientos previos de quimioterapia sistémica para el cáncer de mama metastásico.
    5. Los pacientes deben haber sido tratados previamente con:
    - Taxanos en cualquier contexto.
    - Al menos 1 tratamiento hormonal previo contra el cáncer.
    - Al menos 1 inhibidor de la cinasa dependiente de la ciclina 4/6 en el contexto de metástasis.
    6. Apto para una de las opciones de quimioterapia del grupo TPC.
    7. Progresión de la enfermedad comprobada tras el tratamiento más reciente.
    8. Al menos 1 lesión diana mensurable según RECIST 1.1 (la enfermedad ósea sola no está permitida) que cumpla con todos los criterios siguientes:
    - Lesión de los ganglios linfáticos (GL) que tenga una dimensión al menos ≥1,5 cm en el eje corto.
    - Lesión no ganglionar que mida ≥1,0 cm en el diámetro más largo.
    - La lesión es adecuada para la repetición de la medición mediante TAC/RMN.
    - Las lesiones que han recibido EBRT o tratamiento locorregional deben mostrar pruebas radiográficas de la progresión de la enfermedad basadas en RECIST 1.1 para ser consideradas una lesión diana.
    9. Se debe realizar una RMN cerebral en pacientes con antecedentes de metástasis cerebral. El paciente debe haber tenido una enfermedad estable del SNC durante al menos 4 semanas.
    10. Esperanza de vida de ≥3 meses a partir de la aleatorización basada en la evaluación de los IP.
    11. Estado funcional ECOG de 0 o 1
    12. Función renal adecuada.
    13. Función de la médula ósea adecuada.(Nota: No se permiten las transfusiones de sangre ni el soporte de factores de crecimiento en los 14 días anteriores a la selección del laboratorio).
    14. Función hepática adecuada.
    15. Resolución de todas las toxicidades sistémicas relacionadas con el tratamiento contra el cáncer o la radiación
    de intensidad de grado 1 o inferior, excepto la neuropatía sensorial estable (≤Grado 2) y la alopecia. Los pacientes con neuropatía de grado 2 son aptos, pero no pueden recibir vinorelbina como TPC.
    16. Las mujeres no deben estar amamantando ni embarazadas en la selección o al inicio. Se requiere una evaluación inicial separada si se obtuvo una prueba de embarazo en suero de selección negativa más de 72 horas antes de la primera dosis del fármaco del ensayo.
    - Se considerará que todas las mujeres son fértiles, a menos que sean posmenopáusicas o hayan sido esterilizadas quirúrgicamente.
    17. Las mujeres en edad fértil no deben haber tenido relaciones sexuales sin protección en los 30 días previos a la entrada en el ensayo y deben estar de acuerdo en usar un método anticonceptivo altamente eficaz durante todo el período del ensayo y 120 días después de la interrupción del fármaco del ensayo. Las mujeres que utilicen anticonceptivos hormonales deben haber recibido una dosis estable del mismo anticonceptivo hormonal durante al menos 28 días antes de la dosis y deben continuar utilizando el mismo anticonceptivo durante el ensayo y 120 días después de la interrupción del fármaco del ensayo.
    18. Los hombres que son pareja de mujeres en edad fértil deben usar preservativo y espermicida y sus parejas femeninas, deben usar un método anticonceptivo altamente eficaz que empiece por lo menos 1 ciclo menstrual antes de comenzar a tomar el/los fármaco(s) del ensayo, durante todo el periodo del ensayo y 6 meses después de la
    última dosis del fármaco del ensayo, salvo que los hombres practiquen la abstinencia sexual total o se hayan sometido a una vasectomía satisfactoria con azoospermia confirmada o salvo que las parejas femeninas hayan sido esterilizadas
    quirúrgicamente o se haya demostrado que son estériles por otros motivos. No se permite la donación de esperma durante el periodo del ensayo o 6 meses después de la interrupción del fármaco del ensayo.
    19. El paciente debe estar dispuesto y ser capaz de cumplir con todos los aspectos del protocolo.
    aleatorización.
    E.4Principal exclusion criteria
    1. Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations.
    2. Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
    3. Treatment with chemotherapy or biological therapy within 3 weeks prior to the first dose of study treatment, or radiation or small molecule targeted therapy within 2 weeks prior to the first dose of study treatment.
    4. Existing anticancer treatment-related AEs of Grade ≥2 (except for alopecia and Grade 2 sensory neuropathy) according to NCI-CTCAE v5.0.
    5. Any other malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 5 years prior to enrollment in this study.
    6. History of significant cardiovascular disease, defined as:
    - Congestive heart failure greater than New York Heart Association (NYHA) Class II according to the NYHA Functional Classification.
    - Unstable angina or myocardial infarction within 6 months before enrollment.
    - Serious cardiac arrhythmia.
    7. Clinically significant ECG abnormality, including:
    - Marked Baseline prolonged QT/QTc interval (ie, a repeated demonstration of a QTc interval >500 ms) demonstrated on ECG at Screening.
    - History of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome).
    8. Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤10mg/day of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.
    9. Active hepatitis B virus (positive hepatitis B surface antigen) or active hepatitis C virus (measurable viral RNA load with polymerase chain reaction) infection.
    10. Scheduled surgery during the study, other than minor surgery which would not delay study treatment.
    11. Has an active infection requiring IV systemic therapy.
    12. Subjects with active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) and subjects with a history of bowel obstruction.
    13. Subjects who have received a live vaccine within 30 days of randomization.
    14. Known hypersensitivity or intolerance to either of the study drugs or any of the excipients.
    15. Any medical or other condition which, in the opinion of the Investigator, causes the subject to be medically unfit to receive Sacituzumab Govitecan, or unsuitable for any other reason.
    16. Is receiving any medication prohibited in combination with the study treatment(s) as described in the respective product labels, unless medication was stopped within 7 days prior to randomization.
    17. Locally advanced MBC (stage IIIc) in subjects who are candidates for curative intent therapy at the time of study enrollment.
    18. Has Gilbert’s disease.
    1. Tratamiento previo con inhibidores de topoisomerasa 1 como forma libre u otras formulaciones.
    2. Participación actual en otro ensayo clínico o haber tomado algún fármaco o usado algún dispositivo en fase de investigación en los 28 días anteriores del consentimiento informado.
    3. Tratamiento biológico o quimioterapia en las 3 semanas anteriores a la primera dosis del tratamiento del ensayo, o terapia dirigida con radiación o moléculas pequeñas en las 2 semanas anteriores a la primera dosis del tratamiento del ensayo.
    4. AA relacionados con el tratamiento contra el cáncer existentes de grado ≥2 (salvo alopecia y neuropatía sensorial de grado 2) de acuerdo con el NCI-CTCAE v5.0.
    5. Cualquier otra neoplasia maligna que requiera tratamiento o que haya mostrado indicios de recurrencia (excepto el cáncer de piel no melanoma, o la escisión completa histológicamente confirmada de carcinoma in situ) durante los 5 años anteriores a la inscripción en este ensayo.
    6. Antecedentes de enfermedad cardiovascular significativa, definida como:
    - Insuficiencia cardíaca congestiva mayor que la clase II de la New York Heart Association (NYHA) según la clasificación funcional de la NYHA.
    - Angina inestable o infarto de miocardio en los 6 meses anteriores a la inscripción.
    - Arritmia cardíaca grave.
    7. Anomalía del ECG clínicamente significativa, incluido:
    - Intervalo QT/QTc inicial prolongado (es decir, una demostración repetida de un intervalo QTc >500 ms) demostrado en el ECG de la selección.
    - Antecedentes de factores de riesgo para la torsade de pointes (p. ej., insuficiencia cardíaca,hipopotasemia, antecedentes familiares de síndrome de QT largo).
    8. Presencia de metástasis activas conocidas del SNC y/o meningitis carcinomatosa. Los pacientes con metástasis cerebrales previamente tratadas pueden participar siempre y cuando tengan una enfermedad estable del SNC durante al menos 4 semanas anteriores a la primera dosis del fármaco del ensayo y todos los síntomas neurológicos hayan regresado al inicio, no muestren indicios de metástasis cerebrales nuevas o en aumento, y estén tomando ≤10mg/día de prednisona o su equivalente. Se excluyen todos los pacientes con meningitis carcinomatosas, independientemente de la estabilidad clínica.
    9. Infección por virus activo de la hepatitis B (antígeno de superficie positivo de la hepatitis B) o virus activo de la hepatitis C (carga viral mensurable de ARN con reacción en cadena de la polimerasa.
    10. Cirugía programada durante el ensayo, aparte de la cirugía menor que no retrasaría el tratamiento del ensayo.
    11. Presencia de una infección activa que requiera tratamiento sistémico intravenoso.
    12. Pacientes con enfermedad intestinal inflamatoria crónica activa (colitis ulcerosa, enfermedad de Crohn) y pacientes con antecedentes de obstrucción intestinal.
    13. Pacientes que hayan recibido una vacuna viva en los 30 días siguientes a la aleatorización.
    14. Hipersensibilidad o intolerancia conocida a alguno de los fármacos o excipientes del ensayo.
    15. Cualquier enfermedad que, en opinión del Investigador, provoque que el paciente sea médicamente incapaz de recibir Sacituzumab Govitecan, o no apto por cualquier otra razón.
    16. Recibe algún medicamento prohibido en combinación con el/los tratamiento(s) del ensayo según se describe en las etiquetas de los respectivos productos, a menos que se haya interrumpido la administración del medicamento en los 7 días anteriores a la aleatorización.
    17. Cáncer de mama metastásico localmente avanzado (estadio IIIc) en pacientes que son candidatos para el tratamiento con intención curativa en el momento de la inscripción en el ensayo.
    18. Presencia de la enfermedad de Gilbert.
    E.5 End points
    E.5.1Primary end point(s)
    - Progression-free survival (PFS) as determined by a local investigator
    review [LIR].
    - Objective (overall) response rate (ORR) between treatment arms as determined by blinded independent central review (BICR)
    - Supervivencia sin progresión (SSP) conforme a la revisión de un investigador local (RIL).
    - Tasa de respuesta (global) objetiva (TRO) entre los grupos de tratamiento según lo determinado por la revisión central independiente con enmascaramiento (RCIE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    Monitorizado a lo largo del estudio
    E.5.2Secondary end point(s)
    - Overall survival (OS) as determined by time from start of study for a subject until their death or lost to follow-up.
    - Duration of Overall Response (DOR) as determined by a local investigator review [LIR].
    - Clinical benefit rate (CBR) as assessed by overall response of complete response (CR) or response (PR) or durable stable disease (duration more than 6 months) determined by a local investigator review [LIR].
    - Quality of life assessed by HRQoL, EORTC, QLQ-C30 and PRO-CTCAE.
    - Safety and tolerability as assessed by adverse events, safety laboratories and evaluations, incidence of dose delays and dose reductions, and treatment discontinuations due to adverse events
    - Supervivencia global (SG) según lo determinado por el tiempo transcurrido desde el inicio del ensayo para un paciente hasta su muerte o la pérdida de seguimiento.
    - Duración de la respuesta global (DRG) según lo determinado por la revision de un investigador local (RIL).
    - Tasa de beneficio clínico (TBC) según lo evaluado por la respuesta global de la respuesta completa (RC), la respuesta parcial (RP) o la enfermedad estable y duradera (duración de más de 6 meses) determinado por la revisión de un investigador local (RIL).
    - Calidad de vida evaluada por HRQoL, EORTC, QLQ-C30 y PRO-CTCAE.
    - Seguridad y tolerabilidad evaluadas por acontecimientos adversos, laboratorios y evaluaciones de seguridad, incidencia de retrasos y reducciones de dosis, e interrupciones del tratamiento debido a acontecimientos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    Monitorizado a lo largo del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    France
    Germany
    Hong Kong
    Italy
    Korea, Republic of
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study is defined as the point in time when the number of progression events required for the primary analyses have been reached or if the Sponsor terminates the study, whichever comes first. The primary analyses are expected to occur a minimum of 9 months after the last subject is randomized to the study. Survival data may continue to be collected after End of Study.
    El final del ensayo se define como el momento en que se alcanza el número de episodios de progresión requeridos para los análisis principales o si el Promotor termina el ensayo, lo que ocurra primero.
    Se prevé que los análisis principales tengan lugar un mínimo de 9 meses después de la aleatorización del último paciente al ensayo. Los datos de supervivencia pueden continuar recogiéndose tras el final del ensayo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 215
    F.4.2.2In the whole clinical trial 400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who are deriving benefit from Sacituzumab Govitecan after evaluating the primary and secondary efficacy outcome measures and safety data gathered in the study may continue to receive treatment in a rollover study.
    Los pacientes que se benefician de Sacituzumab Govitecan tras evaluar los resultados de la eficacia principal y secundaria y los datos de seguridad recopilados en el ensayo pueden continuar recibiendo tratamiento en un ensayo de continuación.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA