Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Biomarker/Laboratory analysis, Supportive care, Treatment Completed 18 to 45 Other GIM-6 GIM-PROMISE, EU-20606, GIM-5104, NCT00311636

Objectives

Primary

1. 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

1. Compare the toxicity of adjuvant chemotherapy and triptorelin vs adjuvant chemotherapy alone.

Entry Criteria

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

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

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

Expected Enrollment

A total of 280 patients will be accrued for this study.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Gruppo Italiano Mammella

Lucia Del Mastro, MD, Protocol chair		Ph: 39-010-560-0666 Email: lucia.delmastro@istge.it

Registry Information
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]
Trial Start Date		2003-09-05
Trial Completion Date		2008-01-21
Registered in ClinicalTrials.gov		NCT00311636
Date Submitted to PDQ		2006-02-07
Information Last Verified		2008-04-06