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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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00311636
First received: April 5, 2006
Last updated: June 25, 2013
Last verified: April 2008

April 5, 2006
June 25, 2013
September 2003
January 2008   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00311636 on ClinicalTrials.gov Archive Site
Toxicity as measured by Common Toxicity Criteria at each chemotherapy course
Not Provided
Not Provided
Not Provided
 
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
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]

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
  • Drug: cyclophosphamide
  • Drug: docetaxel
  • Drug: doxorubicin hydrochloride
  • Drug: epirubicin hydrochloride
  • Drug: fluorouracil
  • Drug: methotrexate
  • Drug: paclitaxel
  • Drug: triptorelin
  • Procedure: adjuvant therapy
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
April 2008
January 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00311636
GIM-6, CDR0000468839, GIM-PROMISE, EU-20606, GIM-5104
Not Provided
Not Provided
Gruppo Italiano Mammella (GIM)
Not Provided
Study Chair: Lucia Del Mastro, MD National Institute for Cancer Research, Italy
National Cancer Institute (NCI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP