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

NCT00311636 | Completed Phase 3

• 5 other identifiers: GIM-6CDR0000468839GIM-PROMISEEU-20606GIM-5104
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 18

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Toxicity as measured by Common Toxicity Criteria at each chemotherapy course

Interventions

cyclophosphamide DRUG

docetaxel DRUG

doxorubicin hydrochloride DRUG

epirubicin hydrochloride DRUG

fluorouracil DRUG

methotrexate DRUG

paclitaxel DRUG

triptorelin DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gruppo Italiano Mammella (GIM): lead

Study Sites (18)

Ospedale Civile

Castelfranco - TV, 31033, Italy

Location

Ospedale Sant Anna

Como, 22100, Italy

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Azienda Ospedaliera di Firenze

Florence, 50011, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Presidio Ospedaliero di Livorno

Livorno, 57100, Italy

Location

Carlo Poma Hospital

Mantova, 46100, Italy

Location

Federico II University Medical School

Naples, 80131, Italy

Location

Seconda Universita di Napoli

Naples, 80131, Italy

Location

Istituto G. Pascale

Naples, 81131, Italy

Location

Ospedale Silvestrini

Perugia, 06156, Italy

Location

Ospedale Santa Chiara Pisa

Pisa, 56126, Italy

Location

Istituto Regina Elena

Rome, 00128, Italy

Location

Ospedale Civile ASL 1

Sassari, 07100, Italy

Location

Ospedale SS Trinita

Sora, 03039, Italy

Location

Ospedale Treviglio Caravaggio

Treviglio, 24047, Italy

Location

Ospedale Maggiore dell' Universita

Trieste, 34100, Italy

Location

Universita di Torino

Turin, 10126, Italy

Location

Related Publications (2)

• 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.

  PMID: 21771987 RESULT

• 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.

  PMID: 26720025 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Fluorouracil; Methotrexate; Paclitaxel; Triptorelin Pamoate; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Lucia Del Mastro, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 6, 2006
• Study Start: September 1, 2003
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 26, 2013

Record last verified: 2008-04

Locations

IT (18)