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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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00311636
First received: April 5, 2006
Last updated: June 25, 2013
Last verified: April 2008
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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:
  • Toxicity as measured by Common Toxicity Criteria at each chemotherapy course

Estimated Enrollment: 280
Study Start Date: September 2003
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311636

Locations
Italy
Ospedale Civile
Castelfranco - TV, Italy, 31033
Ospedale Sant Anna
Como, Italy, 22100
Ospedale Santa Croce
Cuneo, Italy, 12100
Azienda Ospedaliera di Firenze
Florence, Italy, 50011
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Presidio Ospedaliero di Livorno
Livorno, Italy, 57100
Carlo Poma Hospital
Mantova, Italy, 46100
Federico II University Medical School
Naples, Italy, 80131
Istituto G. Pascale
Naples, Italy, 81131
Seconda Universita di Napoli
Naples, Italy, 80131
Ospedale Silvestrini
Perugia, Italy, 06156
Ospedale Santa Chiara Pisa
Pisa, Italy, 56126
Istituto Regina Elena
Rome, Italy, 00128
Ospedale Civile ASL 1
Sassari, Italy, 07100
Ospedale SS Trinita
Sora, Italy, 03039
Ospedale Treviglio Caravaggio
Treviglio, Italy, 24047
Ospedale Maggiore dell' Universita
Trieste, Italy, 34100
Universita di Torino
Turin, Italy, 10126
Sponsors and Collaborators
Gruppo Italiano Mammella (GIM)
Investigators
Study Chair: Lucia Del Mastro, MD National Institute for Cancer Research, Italy
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00311636     History of Changes
Other Study ID Numbers: GIM-6, CDR0000468839, GIM-PROMISE, EU-20606, GIM-5104
Study First Received: April 5, 2006
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Doxorubicin
Epirubicin
Fluorouracil
Liposomal doxorubicin
Methotrexate
Triptorelin Pamoate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Contraceptive Agents
Contraceptive Agents, Female
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Luteolytic Agents

ClinicalTrials.gov processed this record on November 27, 2014