Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

Study Overview
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Brief Summary
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RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening. PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early menopause in premenopausal women who are receiving chemotherapy for stage I, stage II, or stage III breast cancer that has been removed by surgery.

Detailed Description
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OBJECTIVES: Primary Evaluate the incidence of chemotherapy-induced early menopause in premenopausal women undergoing adjuvant chemotherapy in combination with vs without triptorelin for previously resected stage I-III breast cancer. Secondary Compare the toxicity of adjuvant chemotherapy and triptorelin vs adjuvant chemotherapy alone. OUTLINE: This is a prospective, open-label, multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I (adjuvant chemotherapy alone): Patients receive adjuvant chemotherapy alone. Arm II (adjuvant chemotherapy and triptorelin): Patients receive adjuvant chemotherapy and triptorelin intramuscularly 1 week before and then every 4 weeks for the duration of chemotherapy. The last dose of triptorelin is given before the last course of chemotherapy. Patients with hormone-sensitive tumors who resume ovarian function after stopping chemotherapy and triptorelin restart triptorelin until ovarian function is suppressed for 2 years. Patients undergo menopausal status assessment, using follicle-stimulating hormone, luteinizing hormone, and estradiol as biochemical markers, at baseline and 3, 6, 9, and 12 months after the last course of chemotherapy. After completion of study treatment, patients are followed at 3, 6, 9, and 12 months. PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.

Official Title
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Prevention of Chemotherapy-induced Menopause by Temporary Ovarian Suppression With Triptorelin Vs. Control in Young Breast Cancer Patients. A Randomized Phase III Multicenter Study [PROMISE]

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: cyclophosphamide
* Drug: docetaxel
* Drug: doxorubicin hydrochloride
* Drug: epirubicin hydrochloride
* Drug: fluorouracil
* Drug: methotrexate
* Drug: paclitaxel
* Drug: triptorelin
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer resected at time of original diagnosis Stage I-III disease Candidate for 1 of the following adjuvant chemotherapy regimens: FEC (fluorouracil, epirubicin hydrochloride, and cyclophosphamide) every 21 or 28 days CMF (cyclophosphamide, methotrexate, and fluorouracil) every 28 days A→CMF (doxorubicin hydrochloride followed by CMF) EC→P (epirubicin hydrochloride and cyclophosphamide every 21 days followed by paclitaxel every 21 days) FEC→P (FEC every 21 days followed by paclitaxel every 21 days) EC→D (EC every 21 days followed by docetaxel every 21 days) AC (doxorubicin hydrochloride and cyclophosphamide) every 21 days AC→P (AC every 21 days followed by paclitaxel every 21 days) E→CMF (epirubicin hydrochloride followed by CMF every 28 days) No evidence of metastases or localized or distant recurrence Investigation to exclude metastases required for any suspicious manifestation Premenopausal, defined as the presence of active menstrual cycles or normal menses within six weeks before initiation of chemotherapy Hormone receptor status not specified PATIENT CHARACTERISTICS: Female No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or adequately treated in situ carcinoma of the cervix No history of noncompliance to medical regimens or patients who are considered potentially unreliable Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy and/or radiotherapy for cancer or non-neoplastic disease No other concurrent hormonal therapy except for tamoxifen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclophosphamide|nan|
|Drug: docetaxel|nan|
|Drug: doxorubicin hydrochloride|nan|
|Drug: epirubicin hydrochloride|nan|
|Drug: fluorouracil|nan|
|Drug: methotrexate|nan|
|Drug: paclitaxel|nan|
|Drug: triptorelin|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as measured by Common Toxicity Criteria at each chemotherapy course |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer