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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT00311636 (opens ClinicalTrials.gov in a new tab)Other idGIM-6Other idCDR0000468839Other idGIM-PROMISEOther idEU-20606

Overview

Status
Completed
Phase
Phase 3
Enrollment
280 participants (estimated)
Sponsor
Gruppo Italiano Mammella (GIM) · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Italy

Start
Sept 2003
Primary completion
Jan 2008
Completion
Apr 2008
First posted
6 Apr 2006 (estimated)
Last update posted
26 Jun 2013 (estimated)
Conditions
Breast Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2003200420052006200720082009
  1. Ph 3

    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

    Sept 2003 to Apr 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • cyclophosphamideDrug
  • docetaxelDrug
  • doxorubicin hydrochlorideDrug
  • epirubicin hydrochlorideDrug
  • fluorouracilDrug
  • methotrexateDrug
  • paclitaxelDrug
  • triptorelinDrug
  • adjuvant therapyProcedure

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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)
  1. Toxicity as measured by Common Toxicity Criteria at each chemotherapy course

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2015

3 results

Ovarian Suppression With Triptorelin During Adjuvant Breast Cancer Chemotherapy and Long-term Ovarian Function, Pregnancies, and Disease-Free Survival: A Randomized Clinical Trial.

Lambertini et al. 2015JAMAcited by 149

PMID 26720025DOI 10.1001/jama.2015.17291PUB-26720025

Full text at the publisher3 results

Indexing hint: Randomized controlled trial · 2011

1 result

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 et al. 2011JAMAcited by 255

PMID 21771987DOI 10.1001/jama.2011.991PUB-21771987

Full text at the publisher1 result

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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