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

Conditions

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

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.

Camilla Marrocco, B Conte, Giovanni A. Rossi, Chiara Pirrone, Diletta Favero et al. (15 authors)

Human Reproduction2022-06-29

10.1093/humrep/deac107.435

Final analysis of the PROMISE-GIM6 phase III trial assessing GnRH agonist use during chemotherapy as a strategy to preserve ovarian function in premenopausal patients with early breast cancer.

Matteo Lambertini, Luca Boni, Andrea Michelotti, Emanuela Magnolfi, Alessio Aligi Cogoni et al. (16 authors)

Journal of Clinical Oncology2021-05-203 citations

10.1200/jco.2021.39.15_suppl.516

Ovarian Suppression With Triptorelin During Adjuvant Breast Cancer Chemotherapy and Long-term Ovarian Function, Pregnancies, and Disease-Free Survival

Matteo Lambertini, Luca Boni, Andrea Michelotti, Teresa Gamucci, Tiziana Scotto et al. (17 authors)

JAMA2015-12-22203 citations

10.1001/jama.2015.17291

Long-term outcome results of the phase III PROMISE-GIM6 study evaluating the role of LHRH analog (LHRHa) during chemotherapy (CT) as a strategy to reduce ovarian failure in early breast cancer (BC) patients.

Matteo Lambertini, Luca Boni, Andrea Michelotti, Teresa Gamucci, N. Olmeo et al. (14 authors)

Journal of Clinical Oncology2014-09-1015 citations

10.1200/jco.2014.32.26_suppl.105

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.

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.

2011-07-01244 citations

10.1001/jama.2011.991

Interventions

DRUGcyclophosphamide

DRUGdocetaxel

DRUGdoxorubicin hydrochloride

DRUGepirubicin hydrochloride

DRUGfluorouracil

DRUGmethotrexate

DRUGpaclitaxel

DRUGtriptorelin

PROCEDUREadjuvant therapy

Study design

Allocation

RANDOMIZED

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Toxicity as measured by Common Toxicity Criteria at each chemotherapy course	—

Countries

Italy

Outcome results

None listed