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 - Full Text View

Sponsored by:	Gruppo Italiano Mammella
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00311636

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 III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menopause Surgery

Drug Information available for: Cyclophosphamide Fluorouracil Methotrexate Doxorubicin Doxorubicin hydrochloride Paclitaxel Epirubicin hydrochloride Epirubicin Triptorelin Myocet Docetaxel Triptorelin pamoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label
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]

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
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

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

Locations

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

Sponsors and Collaborators

Gruppo Italiano Mammella

Investigators

Study Chair:

Lucia Del Mastro, MD

Istituto Nazionale per la Ricerca sul Cancro

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000468839, GIM-6, GIM-PROMISE, EU-20606, GIM-5104
Study First Received:	April 5, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00311636 History of Changes
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

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Contraceptive Agents
Contraceptive Agents, Female
Cyclophosphamide
Docetaxel
Anti-Bacterial Agents
Methotrexate
Alkylating Agents
Breast Diseases
Antineoplastic Agents, Hormonal
Skin Diseases
Menopause, Premature
Adjuvants, Immunologic
Breast Neoplasms

Antimitotic Agents
Folic Acid Antagonists
Epirubicin
Immunosuppressive Agents
Doxorubicin
Folic Acid
Triptorelin
Paclitaxel
Fluorouracil
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Menopause

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms by Site
Therapeutic Uses
Abortifacient Agents
Methotrexate

Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Breast Diseases
Antineoplastic Agents, Hormonal
Skin Diseases
Mitosis Modulators
Breast Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Luteolytic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Epirubicin

ClinicalTrials.gov processed this record on May 07, 2009