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    Summary
    EudraCT Number:2017-002771-25
    Sponsor's Protocol Code Number:NSABP_B-59/GBG96
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-06
    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 ConcernedGermany - PEI
    A.2EudraCT number2017-002771-25
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase III Clinical Trial of
    Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo (GeparDouze)
    Randomisierte, doppelblinde Phase III Studie zur Untersuchung von Atezolizumab oder Placebo in Kombination mit einer neoadjuvanten Chemotherapie gefolgt von einer adjuvanten Monotherapie mit Atezolizumab oder Placebo bei triple- negativem Brustkrebs (GeparDouze)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neoadjuvant chemotherapy with Atezolizumab or Placebo followed by adjuvant Atezolizumab or Placebo
    Neoadjuvante Chemotherapie mit Atezolizumab oder Placebo gefolgt Atezolizumab oder Placebo adjuvant.
    A.3.2Name or abbreviated title of the trial where available
    GeparDouze
    GeparDouze
    A.4.1Sponsor's protocol code numberNSABP_B-59/GBG96
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03281954
    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 SponsorNSABP Foundation
    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 supportRoche Genentech
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGerman Breast Group
    B.5.2Functional name of contact pointGerman Breast Group
    B.5.3 Address:
    B.5.3.1Street AddressMartin-Behaim-Str. 12
    B.5.3.2Town/ cityNeu-Isenburg
    B.5.3.3Post code63263
    B.5.3.4CountryGermany
    B.5.6E-mailgepardouze@gbg.de
    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 Yes
    D.2.1.1.1Trade name TECENTRIQ
    D.2.1.1.2Name of the Marketing Authorisation holderHoffmann-La Roche Ltd
    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 nameAtezolizumab 1200 mg/ml
    D.3.2Product code RO5541267/F03
    D.3.4Pharmaceutical form Concentrate for 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 INNATEZOLIZUMAB
    D.3.9.3Other descriptive nameAtezolizumab
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSterile concentrate
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with early breast cancer
    Patienten mit primärem Brustkrebs
    E.1.1.1Medical condition in easily understood language
    Patients with early breast cancer
    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 10007050
    E.1.2Term Cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Pathologic complete response (pCR) in the breast and lymph nodes (ypT0/Tis ypN0)
    Aim: To determine whether the addition of atezolizumab to chemotherapy improves pCR in the breast and post-therapy lymph nodes.
    Event-free survival (EFS)
    Aim: To determine whether the addition of atezolizumab to chemotherapy followed by adjuvant atezolizumab improves EFS.

    E.2.2Secondary objectives of the trial
    - Pathologic complete response in the breast (ypT0/Tis)
    - Pathologic complete response in the breast and lymph
    nodes (ypT0 ypN0)
    - Positive nodal status conversion rate
    - Overall survival (OS)
    - Recurrence-free interval (RFI)
    - Distant disease-free survival (DDFS)
    - Brain metastases free survival
    - Toxicity
    - Cardiac safety lead-in study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and for submission of tumor samples.
    - The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
    - A pretreatment research core biopsy of the primary tumor must be performed with submission of 2 cores for required correlative studies.
    - Local testing on the diagnostic core must have determined the tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines.
    - Central testing for ER, PgR, HER2 and Ki-67 will be performed, and the tumor must be determined to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP Guidelines Recommendations. Stromal TILs wil be evaluated in three groups: low immune infiltrate (0-10% stromal TILs), intermediate immune infiltrate(11-59% stromal TILs), LPBC (060-100% stromal TILs. Material from either the diagnostic core biopsy or the research biopsy can be used for central testing depending on local preferences and standards.
    - The tumor specimen must also be used for central testing of PD-L1 Status.
    - Patients must be >= 18 years old.
    - The ECOG performance status must be 0-1
    - The primary tumor can be clinical stage T2 or T3, if clinically node negative according to AJCC 7th Edition. If the regional lymph nodes are cN1 and cytologically or histologically positive or cN2–N3 with or without a biopsy, the primary breast tumor can be clinically T1c, T2, or T3.
    - Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 84 days prior to study entry. If suspicious or abnormal, FNA or core biopsy is recommended. Findings of these evaluations will be used to define the nodal status prior to study entry according to the following criteria:
    • Nodal status – negative
     Imaging of the axilla is negative;
     Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node(s) on imaging is negative;
    • Nodal status – positive
     FNA or core biopsy of the node(s) is cytologically or histologically suspicious or positive.
     Imaging is suspicious or abnormal but FNA or core biopsy was not performed.
    - Patients with synchronous bilateral or multicentric HER2-negative breast cancer are eligible as long as the highest risk tumor is ER-negative and PgR-negative and meets stage eligibility criteria. All of the other invasive tumors must also be HER2-negative by ASCO/CAP Guidelines based on local testing. Central testing to confirm TNBC status is only required for the highest risk tumor.
    - Blood counts performed within 28 days prior to randomization must meet the following criteria:
    • ANC must be  2000/mm3;
    • platelet count must be  100,000/mm3; and
    • hemoglobin must be  10 g/dL.
    - The following criteria for evidence of adequate hepatic function performed within
    28 days prior to randomization must be met:
    • total bilirubin must be  ULN for the lab unless the patient has a bilirubin elevation
     ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin; and
    • alkaline phosphatase must be  2.5 x ULN for the lab; and
    • AST and ALT must be  1.5 x ULN for the lab.
    - Patients with AST or ALT or alkaline phosphatase  ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT, or PET scan) performed within 28 days prior to randomization does not demonstrate metastatic disease and the requirements in criterion above are met.
    - Patients with alkaline phosphatase that is  ULN but 2.5 x ULN or with unexplained bone pain are eligible for inclusion in the study if bone imaging (bone scan, PET-CT scan, or PET scan) performed within 28 days prior to randomization does not demonstrate metastatic disease.
    - Patients with N2 or N3 nodal disease or T3 primary disease must undergo liver and bone imaging (as described in the two sections above) within 28 days prior to randomization, irrespective of baseline lab results, and studies must not demonstrate metastatic disease. Chest imaging with chest x-ray PA and Lateral, CT of the chest, or PET-CT must also be performed.
    - Creatinine clearance 40 mL/min performed within 28 days prior to randomization.
    - A serum TSH and AM cortisol must be obtained within 28 days prior to randomization to obtain a baseline value.
    - The LVEF must be 55% regardless of the cardiac imaging facility's lower limit of normal.
    - For women of childbearing potential: abstinence or use contraceptive methods during the treatment period and for at least 5 months after the last dose of atezolizumab / placebo or 12 months after the last dose of chemotherapy.
    - Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    - Excisional biopsy or lumpectomy performed prior to study entry.
    - FNA alone to diagnose the breast cancer.
    - Surgical axillary staging procedure prior to randomization. Exception: FNA or core biopsy of an axillary node is permitted for any patient. A pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is prohibited.
    - Definitive clinical or radiologic evidence of metastatic disease.
    - Previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
    - Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
    - History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
    - Treatment including radiation therapy, chemotherapy, or targeted therapy, for the currently diagnosed breast cancer prior to randomization.
    - Previous therapy with anthracyclines or taxanes for any malignancy.
    - Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens.
    - Uncontrolled hypertension defined as sustained systolic BP 150 mmHg or diastolic BP 90 mmHg. Patients requiring 3 BP medications are not eligible.
    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
    - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
    - Known allergy or hypersensitivity to the components of the atezolizumab formulation.
    - Known allergy or hypersensitivity to the components of the doxorubicin, cyclophosphamide, carboplatin, or paclitaxel formulations.
    - Known allergy or hypersensitivity to liposomal or pegylated G-CSF formulations.
    - Active or history of autoimmune disease or immune deficiency.
    - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
    - Patients known to be HIV positive.
    - Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening.
    Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines.
    - Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV RNA.
    - Patients with clinically active tuberculosis.
    - Severe infection within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
    - Prior allogeneic stem cell or solid organ transplantation.
    - Patients receiving therapeutic anti-coagulants are not eligible.
    - Administration of a live, attenuated vaccine within 28 days prior to randomization or anticipation that such vaccine will be required during the study. Patients must agree not to receive live, attenuated influenza vaccine within 28 days prior to randomization, during treatment or within 5 months following the last dose of atezolizumab/placebo.
    - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
    - Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
    - Treatment with systemic immunosuppressive medications within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization.
    - Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis [anti-TNF] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study.
    - Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy)  Grade 2, per the CTCAE v4.0.
    - Symptomatic peripheral ischemia.
    - Pregnancy or lactation at the time of randomization or intention to become pregnant during the study. (Note: Negative serum pregnancy test must be obtained within
    14 days prior to randomization).
    - Use of any investigational agent within 28 days prior to randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)
    Endpoint: Defined as the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy (ypT0/Tis ypN0).

    Event-free survival (EFS)
    Endpoint: EFS is defined as time from randomization until event: EFS events are progression on protocol therapy resulting in administration of non-protocol therapy or inoperability, local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause prior to recurrence or second primary cancer.
    E.5.1.1Timepoint(s) of evaluation of this end point
    pCR will be summarized as pathological complete response rate for both randomizations.
    EFS is defined as time from randomization until event
    (assumed that all events will have occured 6 years after study start latest).
    E.5.2Secondary end point(s)
    Pathologic complete response in the breast (ypT0/Tis)
    Aim: To determine whether the addition of atezolizumab to chemotherapy (weekly paclitaxel plus carboplatin followed by AC or EC) improves pathologic complete response in the breast (pCR breast) in patients with triple-negative breast cancer.
    Pathologic complete response in the breast and lymph nodes (ypT0 ypN0)
    Aim: To determine whether the addition of atezolizumab to chemotherapy (weekly paclitaxel plus carboplatin followed by AC or EC) improves pathologic complete response in the breast and post-therapy lymph nodes evaluated histologically (pCR breast and nodes) in patients with triple-negative negative breast cancer.
    Positive nodal status conversion rate
    Aim: To determine whether the addition of atezolizumab to chemotherapy (weekly paclitaxel plus carboplatin followed by AC or EC) improves conversion rate from node-positive to node-negative.
    Overall survival (OS)
    Aim: To determine whether the addition of atezolizumab to chemotherapy (weekly paclitaxel plus carboplatin followed by AC or EC) followed by adjuvant atezolizumab improves overall survival (OS) in patients with triple-negative breast cancer.
    Recurrence-free interval (RFI)
    Aim: To determine whether the addition of atezolizumab to chemotherapy (weekly paclitaxel plus carboplatin followed by AC or EC) followed by adjuvant atezolizumab improves recurrence-free interval (RFI) in patients with triple-negative breast cancer.
    Distant disease-free survival (DDFS)
    Aim: To determine whether the addition of atezolizumab to chemotherapy (weekly paclitaxel plus carboplatin followed by AC or EC) followed by adjuvant atezolizumab improves distant disease-free survival (DDFS) in patients with triple-negative breast cancer.
    Brain metastases free survival
    Aim: To determine whether the addition of atezolizumab to chemotherapy (weekly paclitaxel plus carboplatin followed by AC or EC) followed by adjuvant atezolizumab improves brain metastases free survival in women with triple-negative breast cancer.
    Toxicity
    Aim: To evaluate toxicity associated with study therapy added to chemotherapy and radiation therapy.
    Aim: To evaluate immune-adverse events of special interest.
    Cardiac safety lead-in study
    Aim: To assess for potential augmentation of anthracycline-related cardiac toxicity with co-administration of study therapy.

    E.5.2.1Timepoint(s) of evaluation of this end point
    pCR in the breast (ypT0/Tis) defined as the absence of any invasive component in the resected breast specimen.
    pCR in the breast and lymph nodes (ypT0 ypN0
    defined as the absence of any invasive component or DCIS in the resected breast specimen and all resected lymph nodes.
    Positive nodal status conversion rate
    Percentage of patients clinically node-positive that convert to pathologically node-negative following completion of neoadjuvant chemotherapy.
    OS defined as time until death from any cause.
    RFI defined as time until invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes).
    DDFS defined as time until distant recurrence, death from breast cancer, death from other causes, and second primary invasive cancer (non-breast).
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned60
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    Canada
    Spain
    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
    time point until 298 events will have occured (anticipated 6 years after recruitment start)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 760
    F.4.2.2In the whole clinical trial 1520
    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)
    No study specific treatment or investigation is planned after end of systemic Treatment, follow up is scheduled to end after occurence of 298 events. However, Information on subsequemt cancer specific treatments and the health status of the patients is collected either based on yearly Chart reviews at the sites or based on information deriving from the GBG registry of previous study participants.
    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 Decision2018-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-03
    P. End of Trial
    P.End of Trial StatusOngoing
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