- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02053597
TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen (TRIUMPH)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1000
- Jules Bordet Institute
-
Brussels, Belgium, 1070
- Hôpital Erasme
-
Namur, Belgium, 5000
- Clinique et Maternite Sainte Elisabeth
-
-
Wilrijk
-
Antwerp, Wilrijk, Belgium, 2610
- GZA Ziekenhuisen Campus Sint-Augustinus - Iridium Kankernetwerk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≤ 40 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Non-metastatic primary invasive carcinoma of the breast eligible for adjuvant or neoadjuvant chemotherapy.
- Negative estrogen (ER) and progesterone receptor (PgR) status.
- Baseline left ventricular ejection fraction (LVEF) ≥50% measured by an echocardiogram or MUGA.
- Interested in maintaining menstrual and/or ovarian function following completion of chemotherapy.
- Known HER2/neu status.
- Negative pregnancy test within 14 days prior to starting chemotherapy.
- Adequate hematologic, hepatic and renal function.
- Signed informed consent.
Exclusion Criteria:
- 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.
- Previous history of amenorrhea > 3 months within the last 2 years (excluding pregnancy).
- Ovarian insufficiency defined as serum FSH > 20 IU/L at the local laboratory, anytime during the menstrual cycle.
- Any ovarian pathology or abnormalities at the screening pelvic ultrasound, except for functional follicular cysts.
- Pregnant or breastfeeding patients.
- 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.
- Concurrent use of any other cytotoxic or hormonal agent, namely GnRH agonists.
- Prior pre-existing peripheral neuropathy of any cause, including diabetes mellitus, alcohol abuse, HIV infection, autoimmune and hereditary neuropathies, amyloidosis, hypothyroidism, vitamin deficiencies.
- Serious cardiac illness, uncontrolled hypertension or medical condition that would affect administration of chemotherapy and compliance to study procedures.
- Known sensitivity to any of the study medications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: doxorubicin and paclitaxel
All patients will receive four cycles of doxorubicin (A) (50 mg/m2) and paclitaxel (P) (200 mg/m2), given on a three-weekly basis for four cycles, followed by weekly paclitaxel (P) (80 mg/m2) for twelve weeks.
|
All patients will receive four cycles of doxorubicin (A) (50 mg/m2)
All patients will receive four cycles paclitaxel (P) (200 mg/m2), given on a three-weekly basis for four cycles, followed by weekly paclitaxel (P) (80 mg/m2) for twelve weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in ovarian function
Time Frame: At screening, after 4 cycles of chemotherapy, at the end of chemotherapy, at 6, 12, 18 and 24 months following chemotherapy
|
Ovarian function will be evaluated using serum FSH, estradiol and AMH. Ovarian failure is defined as serum FSH >40 IU/L. Ovarian insufficiency is defined as serum FSH level from 20 - 40 IU/L. Ovarian reserve will be evaluated by serum AMH. Adequate ovarian reserve is defined as serum AMH >1 ng/ml. Menstrual function will be evaluated by collecting information of the 1st day of last menstrual cycle, and cycle length (days between two menstruating periods). Ovarian function will be evaluated using serum FSH, estradiol and AMH. Ovarian failure is defined as serum FSH >40 IU/L. Ovarian insufficiency is defined as serum FSH level from 20 - 40 IU/L. Ovarian reserve will be evaluated by serum AMH. Adequate ovarian reserve is defined as serum AMH >1 ng/ml. |
At screening, after 4 cycles of chemotherapy, at the end of chemotherapy, at 6, 12, 18 and 24 months following chemotherapy
|
Change from baseline in menstrual function
Time Frame: At screening, after 4 cycles of chemotherapy, at the end of chemotherapy, at 6, 12, 18 and 24 months following chemotherapy
|
Menstrual function will be evaluated by collecting information of the 1st day of last menstrual cycle, and cycle length (days between two menstruating periods).
In patients menstruating regularly after 12 months of chemotherapy cessation, information on menstrual cycle will be collected at 6-monthly intervals until developing menopause, disease recurrence, becoming pregnant, whichever occurs earlier, for a maximum period of 5 years after end of chemotherapy.
|
At screening, after 4 cycles of chemotherapy, at the end of chemotherapy, at 6, 12, 18 and 24 months following chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ovarian reserve
Time Frame: At 12 months following the end of chemotherapy.
|
A serum AMH determination will be performed at 12 months after the end of chemotherapy.
An adequate ovarian reserve is defined as serum AMH >1 ng/ml at that timepoint.
|
At 12 months following the end of chemotherapy.
|
Occurence of Adverse Events
Time Frame: From the signature of informed consent until until the end of study treatment/treatment discontinuation visit 30 days after the last dose of study medication
|
This study will use the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0, for adverse event reporting.
|
From the signature of informed consent until until the end of study treatment/treatment discontinuation visit 30 days after the last dose of study medication
|
Impact of treatment on the behavior of menstruation after menses resumption
Time Frame: At 18, 24 and 60 months after end of chemotherapy.
|
In patients menstruating regularly after 12 months of chemotherapy cessation, information on menstrual cycles will be collected at 18, 24 and up to 60 months after end of chemotherapy, until developing menopause, disease recurrence or becoming pregnant, whichever occurs earlier.
This information will include the date of last menstrual period, menstruation duration and if 2 or more consecutive menstrual cycles were missed, allowing to assess irregularity and possible cessation of menses.
|
At 18, 24 and 60 months after end of chemotherapy.
|
Evaluate the impact of a cyclophosphamide-free regimen on sexual function
Time Frame: At baseline, after 4 cycles, end of chemotherapy, 6, 12 and 24 months following the end of chemotherapy.
|
Patient will complete two validated health-related quality of life questionnaires, one on menopausal symptoms (FACT-ES version 4) and the other on sexual functioning (FSAQ).
|
At baseline, after 4 cycles, end of chemotherapy, 6, 12 and 24 months following the end of chemotherapy.
|
Evaluate the impact of the regimen on peripheral neurotoxicity
Time Frame: At baseline, after 4 cycles, end of chemotherapy, 6, 12 and 24 months following the end of chemotherapy.
|
Patient will complete one validated health-related quality of life questionnaire on peripheral neurotoxicity (FACT-Taxane version 4).
|
At baseline, after 4 cycles, end of chemotherapy, 6, 12 and 24 months following the end of chemotherapy.
|
Pregnancy rate after cessation of chemotherapy
Time Frame: From end of chemotherapy up until 60 months after.
|
Number of pregnancies among participants.
|
From end of chemotherapy up until 60 months after.
|
Event-free survival
Time Frame: From the date of registration up until 60 months after the end of chemotherapy.
|
Event-free survival will be calculated from the date of registration to the study to developing local, loco-regional or distant metastasis, secondary malignancies or death.
All patients will be considered for the primary efficacy analysis (ITT analysis).
|
From the date of registration up until 60 months after the end of chemotherapy.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daphné Tkint de Roodenbeke, MD, PhD, Jules Bordet Institute
- Principal Investigator: Hatem Azim, MD, PhD, Jules Bordet Institute
- Principal Investigator: Isabelle Demeestere, MD, PhD, Hôpital Erasme
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Paclitaxel
- Doxorubicin
Other Study ID Numbers
- CE2142
- 2013-000173-77 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on Doxorubicin
-
Azaya Therapeutics, Inc.UnknownCancer | Ovarian Cancer | Ovarian Epithelial Cancer Recurrent | Malignant Female Reproductive System Neoplasm | Ovarian TumorCanada, United States
-
National Cancer Institute (NCI)CompletedDS Stage I Plasma Cell Myeloma | DS Stage II Plasma Cell Myeloma | DS Stage III Plasma Cell MyelomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Recurrent Breast Carcinoma | Estrogen Receptor Negative | HER2/Neu Negative | Progesterone Receptor Negative | Triple-Negative Breast Carcinoma | Male Breast Carcinoma | Stage IV Breast Cancer AJCC...United States
-
OnxeoCompletedCarcinoma, HepatocellularItaly, Spain, United States, Belgium, Austria, France, Egypt, Germany, Hungary, Turkey, Lebanon
-
Sohag UniversityActive, not recruiting
-
AEterna ZentarisCompletedEndometrial CancerUnited States, Spain, Canada, Ireland, Norway, Austria, Denmark, Israel, United Kingdom, Belgium, Finland, Romania, Czechia, Italy, Poland, Germany, Netherlands, Belarus, Bosnia and Herzegovina, Bulgaria, Russian Federation, Ukraine
-
Falo, Louis, MDActive, not recruitingCutaneous T Cell LymphomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Completed
-
Yale UniversityCompleted
-
SOLTI Breast Cancer Research GroupCompleted