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

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00311636
• Lead Sponsor: Gruppo Italiano Mammella (GIM)

Brief Summary

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

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 Timeline

• Study Start: 2003-09
• Study First Submitted: 2006-04-05
• Study First Submitted QC: 2006-04-05
• Study First Posted: 2006-04-06
• Primary Completion: 2008-01
• Status Verified: 2008-04
• Study Completion: 2008-04
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Toxicity as measured by Common Toxicity Criteria at each chemotherapy course

Trial Locations

Locations (18)

Ospedale Civile; 🇮🇹 Castelfranco - TV, Italy

Istituto Nazionale per la Ricerca sul Cancro; 🇮🇹 Genoa, Italy

Ospedale Sant Anna; 🇮🇹 Como, Italy

Ospedale Santa Croce; 🇮🇹 Cuneo, Italy

Presidio Ospedaliero di Livorno; 🇮🇹 Livorno, Italy

Azienda Ospedaliera di Firenze; 🇮🇹 Florence, Italy

Ospedale Maggiore dell' Universita; 🇮🇹 Trieste, Italy

Carlo Poma Hospital; 🇮🇹 Mantova, Italy

Seconda Universita di Napoli; 🇮🇹 Naples, Italy

Federico II University Medical School; 🇮🇹 Naples, Italy

Ospedale Santa Chiara Pisa; 🇮🇹 Pisa, Italy

Istituto G. Pascale; 🇮🇹 Naples, Italy

Istituto Regina Elena; 🇮🇹 Rome, Italy

Ospedale Silvestrini; 🇮🇹 Perugia, Italy

Ospedale SS Trinita; 🇮🇹 Sora, Italy

Ospedale Civile ASL 1; 🇮🇹 Sassari, Italy

Ospedale Treviglio Caravaggio; 🇮🇹 Treviglio, Italy

Universita di Torino; 🇮🇹 Turin, Italy