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
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| ClinicalTrials.gov Identifier: NCT00311636 |
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Recruitment Status :
Completed
First Posted : April 6, 2006
Last Update Posted : June 26, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: fluorouracil Drug: methotrexate Drug: paclitaxel Drug: triptorelin Procedure: adjuvant therapy | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 280 participants |
| Allocation: | Randomized |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | 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] |
| Study Start Date : | September 2003 |
| Actual Primary Completion Date : | January 2008 |
| Actual Study Completion Date : | April 2008 |
- 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
- Toxicity as measured by Common Toxicity Criteria at each chemotherapy course
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed breast cancer resected at time of original diagnosis
- Stage I-III disease
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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)
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311636
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| Study Chair: | Lucia Del Mastro, MD | IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00311636 |
| Other Study ID Numbers: |
GIM-6 CDR0000468839 ( Registry Identifier: PDQ (Physician Data Query) ) GIM-PROMISE EU-20606 GIM-5104 |
| First Posted: | April 6, 2006 Key Record Dates |
| Last Update Posted: | June 26, 2013 |
| Last Verified: | April 2008 |
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stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Docetaxel Cyclophosphamide Doxorubicin Liposomal doxorubicin Fluorouracil Methotrexate Epirubicin Triptorelin Pamoate Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors |