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

Breast Cancer Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311636
• Other study ID #: GIM-6
• Secondary ID: CDR0000468839GIM
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2006
• Last updated: June 25, 2013
• Start date: September 2003
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• cyclophosphamide

• docetaxel

• doxorubicin hydrochloride

• epirubicin hydrochloride

• fluorouracil

• methotrexate

• paclitaxel

• triptorelin

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
Italy	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	Istituto G. Pascale	Naples
Italy	Seconda Universita di Napoli	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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Mammella (GIM)

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Toxicity as measured by Common Toxicity Criteria at each chemotherapy course