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

• Register: EUCTR
• Last refreshed on: 10 August 2020
• Main ID: EUCTR2013-000173-77-BE
• Date of registration: 08/08/2013
• Prospective Registration: Yes
• Primary sponsor: Institut Jules Bordet
• Public title: A study evaluating the effect of a chemotherapy regimen on the menstrual and ovarian functions of young breast cancer patients
• Scientific title: 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 - TRIUMPH
• Date of first enrolment: 12/02/2014
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000173-77
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium

Contacts

• Name: Breast Data Centre
• Affiliation: Institut Jules Bordet

• Name: Breast Data Centre
• Affiliation: Institut Jules Bordet

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Primary breast cancer (adjuvant or neoadjuvant)
MedDRA version: 17.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0 Level: LLT Classification code 10073289 Term: Premenopausal breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Doxorubicine Sandoz 2 mg/ml solution à diluer pour perfusion
Product Name: Doxorubicin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214-92-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-

Trade Name: Paclitaxin 6 mg/ml solution à diluer pour perfusion
Product Name: Paclitaxel
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Primary Outcome(s)

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

Primary end point(s): - Ovarian function recovery
- Ovarian failure rate

Main Objective: - 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

Secondary Objective: - 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

Secondary Outcome(s)

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

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

Secondary ID(s)

2013-000173-77

Source(s) of Monetary Support

Institut Jules Bordet

Les Amis de l'Institut Bordet

Ethics review

Status: Approved
Approval date: 12/02/2014
Contact: