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

June 25, 2013 updated by: Gruppo Italiano Mammella (GIM)

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]

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Castelfranco - TV, Italy, 31033
        • Ospedale Civile
      • Como, Italy, 22100
        • Ospedale Sant Anna
      • Cuneo, Italy, 12100
        • Ospedale Santa Croce
      • Florence, Italy, 50011
        • Azienda Ospedaliera di Firenze
      • Genoa, Italy, 16132
        • Istituto nazionale Per la Ricerca sul Cancro
      • Livorno, Italy, 57100
        • Presidio Ospedaliero di Livorno
      • Mantova, Italy, 46100
        • Carlo Poma Hospital
      • Naples, Italy, 80131
        • Federico II University Medical School
      • Naples, Italy, 80131
        • Seconda Universita di Napoli
      • Naples, Italy, 81131
        • Istituto G. Pascale
      • Perugia, Italy, 06156
        • Ospedale Silvestrini
      • Pisa, Italy, 56126
        • Ospedale Santa Chiara Pisa
      • Rome, Italy, 00128
        • Istituto Regina Elena
      • Sassari, Italy, 07100
        • Ospedale Civile ASL 1
      • Sora, Italy, 03039
        • Ospedale SS Trinità
      • Treviglio, Italy, 24047
        • Ospedale Treviglio Caravaggio
      • Trieste, Italy, 34100
        • Ospedale Maggiore dell' Universita
      • Turin, Italy, 10126
        • Università di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Toxicity as measured by Common Toxicity Criteria at each chemotherapy course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Mammella (GIM)

Investigators

  • Study Chair: Lucia Del Mastro, MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 5, 2006

First Posted (Estimate)

April 6, 2006

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIM-6
  • CDR0000468839 (Registry Identifier: PDQ (Physician Data Query))
  • GIM-PROMISE
  • EU-20606
  • GIM-5104

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.

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