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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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
cyclophosphamide
docetaxel
doxorubicin hydrochloride
epirubicin hydrochloride
fluorouracil
methotrexate
paclitaxel
triptorelin
adjuvant therapy
Sponsored by
Gruppo Italiano Mammella (GIM)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Ospedale Civile
  • Ospedale Sant Anna
  • Ospedale Santa Croce
  • Azienda Ospedaliera di Firenze
  • Istituto Nazionale per la Ricerca sul Cancro
  • Presidio Ospedaliero di Livorno
  • Carlo Poma Hospital
  • Federico II University Medical School
  • Seconda Universita di Napoli
  • Istituto G. Pascale
  • Ospedale Silvestrini
  • Ospedale Santa Chiara Pisa
  • Istituto Regina Elena
  • Ospedale Civile ASL 1
  • Ospedale SS Trinita
  • Ospedale Treviglio Caravaggio
  • Ospedale Maggiore dell' Universita
  • Universita di Torino

Outcomes

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

Full Information

First Posted
April 5, 2006
Last Updated
June 25, 2013
Sponsor
Gruppo Italiano Mammella (GIM)
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1. Study Identification

Unique Protocol Identification Number
NCT00311636
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gruppo Italiano Mammella (GIM)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
triptorelin
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Toxicity as measured by Common Toxicity Criteria at each chemotherapy course

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia Del Mastro, MD
Organizational Affiliation
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Civile
City
Castelfranco - TV
ZIP/Postal Code
31033
Country
Italy
Facility Name
Ospedale Sant Anna
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Ospedale Santa Croce
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Azienda Ospedaliera di Firenze
City
Florence
ZIP/Postal Code
50011
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Presidio Ospedaliero di Livorno
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Carlo Poma Hospital
City
Mantova
ZIP/Postal Code
46100
Country
Italy
Facility Name
Federico II University Medical School
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Seconda Universita di Napoli
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto G. Pascale
City
Naples
ZIP/Postal Code
81131
Country
Italy
Facility Name
Ospedale Silvestrini
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Ospedale Santa Chiara Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Istituto Regina Elena
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
Ospedale Civile ASL 1
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Ospedale SS Trinita
City
Sora
ZIP/Postal Code
03039
Country
Italy
Facility Name
Ospedale Treviglio Caravaggio
City
Treviglio
ZIP/Postal Code
24047
Country
Italy
Facility Name
Ospedale Maggiore dell' Universita
City
Trieste
ZIP/Postal Code
34100
Country
Italy
Facility Name
Universita di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21771987
Citation
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.
Results Reference
result
PubMed Identifier
26720025
Citation
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.
Results Reference
derived

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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

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