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

Sponsor

Gruppo Italiano Mammella (GIM) (Other)

Overall Status

Completed

CT.gov ID

NCT00311636

Collaborator

(none)

280

Enrollment

Locations

Duration (Months)

15.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Masking:

None (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]

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Ospedale Civile	Castelfranco - TV	Italy	31033
2	Ospedale Sant Anna	Como	Italy	22100
3	Ospedale Santa Croce	Cuneo	Italy	12100
4	Azienda Ospedaliera di Firenze	Florence	Italy	50011
5	Istituto Nazionale per la Ricerca sul Cancro	Genoa	Italy	16132
6	Presidio Ospedaliero di Livorno	Livorno	Italy	57100
7	Carlo Poma Hospital	Mantova	Italy	46100
8	Federico II University Medical School	Naples	Italy	80131
9	Seconda Universita di Napoli	Naples	Italy	80131
10	Istituto G. Pascale	Naples	Italy	81131
11	Ospedale Silvestrini	Perugia	Italy	06156
12	Ospedale Santa Chiara Pisa	Pisa	Italy	56126
13	Istituto Regina Elena	Rome	Italy	00128
14	Ospedale Civile ASL 1	Sassari	Italy	07100
15	Ospedale SS Trinita	Sora	Italy	03039
16	Ospedale Treviglio Caravaggio	Treviglio	Italy	24047
17	Ospedale Maggiore dell' Universita	Trieste	Italy	34100
18	Universita di Torino	Turin	Italy	10126

Sponsors and Collaborators

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