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

NCT ID: NCT00311636

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2008-04-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

methotrexate

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

triptorelin

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Mammella (GIM)

OTHER

Sponsor Role: lead

Principal Investigators

Lucia Del Mastro, MD

Role: STUDY_CHAIR

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Locations

Ospedale Civile

Castelfranco - TV, , Italy

Ospedale Sant Anna

Como, , Italy

Ospedale Santa Croce

Cuneo, , Italy

Azienda Ospedaliera di Firenze

Florence, , Italy

Istituto Nazionale per la Ricerca sul Cancro

Genoa, , Italy

Presidio Ospedaliero di Livorno

Livorno, , Italy

Carlo Poma Hospital

Mantova, , Italy

Federico II University Medical School

Naples, , Italy

Seconda Universita di Napoli

Naples, , Italy

Istituto G. Pascale

Naples, , Italy

Ospedale Silvestrini

Perugia, , Italy

Ospedale Santa Chiara Pisa

Pisa, , Italy

Istituto Regina Elena

Rome, , Italy

Ospedale Civile ASL 1

Sassari, , Italy

Ospedale SS Trinita

Sora, , Italy

Ospedale Treviglio Caravaggio

Treviglio, , Italy

Ospedale Maggiore dell' Universita

Trieste, , Italy

Universita di Torino

Turin, , Italy

Countries

Italy

References

Del Mastro L, Boni L, Michelotti A, Gamucci T, Olmeo N, Gori S, Giordano M, Garrone O, Pronzato P, Bighin C, Levaggi A, Giraudi S, Cresti N, Magnolfi E, Scotto T, Vecchio C, Venturini M. Effect of the gonadotropin-releasing hormone analogue triptorelin on the occurrence of chemotherapy-induced early menopause in premenopausal women with breast cancer: a randomized trial. JAMA. 2011 Jul 20;306(3):269-76. doi: 10.1001/jama.2011.991.

Reference Type: RESULT

PMID: 21771987 (View on PubMed)

Lambertini M, Boni L, Michelotti A, Gamucci T, Scotto T, Gori S, Giordano M, Garrone O, Levaggi A, Poggio F, Giraudi S, Bighin C, Vecchio C, Sertoli MR, Pronzato P, Del Mastro L; GIM Study Group. Ovarian Suppression With Triptorelin During Adjuvant Breast Cancer Chemotherapy and Long-term Ovarian Function, Pregnancies, and Disease-Free Survival: A Randomized Clinical Trial. JAMA. 2015 Dec 22-29;314(24):2632-40. doi: 10.1001/jama.2015.17291.

Reference Type: DERIVED

PMID: 26720025 (View on PubMed)

Other Identifiers

CDR0000468839

Identifier Type: REGISTRY

Identifier Source: secondary_id

GIM-PROMISE

Identifier Type: -

Identifier Source: secondary_id

EU-20606

Identifier Type: -

Identifier Source: secondary_id

GIM-5104

Identifier Type: -

Identifier Source: secondary_id

GIM-6

Identifier Type: -

Identifier Source: org_study_id