Clinical Trials Register

Summary
EudraCT Number:	2013-000173-77
Sponsor's Protocol Code Number:	2013-000173-77
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-08-08
Trial results	View 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

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2013-000173-77

A.3

Full title of the trial

TRIUMPH Trial
A phase II TRial evalUating the Menstrual and ovarian function of young breast cancer patients treated with a cycloPHosphamide-free regimen composed of doxorubicin and paclitaxel

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study evaluating the effect of a chemotherapy regimen on the menstrual and ovarian functions of young breast cancer patients

A.3.2

Name or abbreviated title of the trial where available

TRIUMPH

A.4.1

Sponsor's protocol code number

2013-000173-77

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Institut Jules Bordet
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Institut Jules Bordet
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	Les Amis de l'Institut Bordet
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Institut Jules Bordet
B.5.2	Functional name of contact point	Breast Data Centre
B.5.3	Address:
B.5.3.1	Street Address	Boulevard de Waterloo, 121, 7th floor
B.5.3.2	Town/ city	Brussels
B.5.3.3	Post code	1000
B.5.3.4	Country	Belgium
B.5.4	Telephone number	3225413099
B.5.5	Fax number	3225413477
B.5.6	E-mail	ctregulatory@bordet.be

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Doxorubicine Sandoz 2 mg/ml solution à diluer pour perfusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Sandoz nv/sa, Telecom Gardens, Medialaan 40, B-1800 Vilvoorde
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Doxorubicin
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DOXORUBICIN
D.3.9.1	CAS number	23214-92-8
D.3.9.4	EV Substance Code	SUB06391MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Paclitaxin 6 mg/ml solution à diluer pour perfusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva Pharma Belgium S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Paclitaxel
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

Primary breast cancer (adjuvant or neoadjuvant)

E.1.1.1

Medical condition in easily understood language

Early-stage breast cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10057654
E.1.2	Term	Breast cancer female
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10073289
E.1.2	Term	Premenopausal breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

- Evaluate the impact of a cyclophosphamide-free regimen on the ovarian function recovery defined as menstrual resumption within 12 months following the end of chemotherapy
- Evaluate the impact of a cyclophosphamide-free regimen on the development of ovarian failure defined as serum FSH >40 IU/L at 12 months following the end of chemotherapy

E.2.2

Secondary objectives of the trial

- Evaluate the impact of a cyclophosphamide-free regimen on having an adequate ovarian reserve defined as serum AMH >1 ng/ml at 12 months following the end of chemotherapy
- Evaluate the correlation between AMH level at initiation and ovarian function after treatment
- Evaluate the impact of a cyclophosphamide-free regimen on the behavior of menstruation after resumption
- Evaluate the impact of a cyclophosphamide-free regimen on sexual function
- Evaluate the impact of the AP-P regimen on peripheral neurotoxicity
- Evaluate the rate of pregnancy following cessation of chemotherapy
- Evaluate the impact of a cyclophosphamide-free regimen on event-free survival
- Evaluate ovarian function recovery and ovarian reserve at 24 months

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients must meet ALL of the following criteria in order to be eligible for this study:
1. Age ≤ 40 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
3. Non-metastatic primary invasive carcinoma of the breast eligible for adjuvant or neoadjuvant chemotherapy.
4. Negative estrogen (ER) and progesterone receptor (PgR) status.
5. Baseline left ventricular ejection fraction (LVEF) ≥50% measured by an echocardiogram or MUGA.
6. Interested in maintaining menstrual and/or ovarian function following completion of chemotherapy.
7. Known HER2/neu status.
8. Negative pregnancy test within 14 days prior to starting chemotherapy.
9. Adequate hematologic, hepatic and renal function.
10. Signed informed consent.

E.4

Principal exclusion criteria

Patients meeting any ONE of the following criteria are not eligible for this study:
1. History of prior malignant disease (breast or non-breast) or non-malignant condition which was treated with chemotherapy, pelvic irradiation or any therapy that could potentially affect ovarian function.
2. Previous history of amenorrhea > 3 months within the last 2 years (excluding pregnancy).
3. Ovarian insufficiency defined as serum FSH > 20 IU/L at the local laboratory, anytime during the menstrual cycle.
4. Any ovarian pathology or abnormalities at the screening pelvic ultrasound, except for functional follicular cysts.
5. Pregnant or breastfeeding patients.
6. Inability or unwillingness to use effective contraception during and up to 3 months after the last dose of study medication. Effective methods include the following: non-hormonal intrauterine device, barrier method - condoms, diaphragm – also in conjugation with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.
7. Concurrent use of any other cytotoxic or hormonal agent, namely GnRH agonists.
8. Prior pre-existing peripheral neuropathy of any cause, including diabetes mellitus, alcohol abuse, HIV infection, autoimmune and hereditary neuropathies, amyloidosis, hypothyroidism, vitamin deficiencies.
9. Serious cardiac illness, uncontrolled hypertension or medical condition that would affect administration of chemotherapy and compliance to study procedures.
10. Known sensitivity to any of the study medications.

E.5 End points

E.5.1

Primary end point(s)

- Ovarian function recovery
- Ovarian failure rate

E.5.1.1

Timepoint(s) of evaluation of this end point

- Menstruation resumption rates rates particulary the continutation of menses at months 18,24,36,48 and 60
- Serum follicular stimulating hormone (FSH) levels measured at 12 months after EOC

E.5.2

Secondary end point(s)

- Ovarian function recovery and ovarian reserve at 24 months and 60 months after the end of chemotherapy (EOC)
- Behavior of menstruation after resumption
- Sexual function
- Peripheral neurotoxicity
- Rate of pregnancy following cessation of chemotherapy
- Event-free survival

E.5.2.1

Timepoint(s) of evaluation of this end point

- Serum AMH levels at 24 months after the EOC
- Behavior of menstruation after resumption of menses at after cycle 4 of chemotherapy, EOC, 6 months after EOC, 18 months after EOC, 6,12,18,24,36,48 months after EOC, at end of study (60 months after EOC)
- Sexual function after cycle 4 of chemotherapy (end of AP x 4), EOC, 6 months after EOC, 12 months after EOC, 24 months after EOC, at end of study (60 months after EOC)
- Peripheral neuropathy after cycle 4 of chemotherapy (end of AP x 4), EOC, 6 months after EOC, 12 months after EOC, 24 months after EOC, at end of study (60 months after EOC)
- Rate of pregnancy after EOC until end of study
- Event-free survival until end of study

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

All patients will be followed-up for event-free survival and becoming pregnant as per standard clinical practice for five years after end of chemotherapy (EOC).

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

At the discretion of the physician according to local practice.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-09-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-02-12

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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