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Study · Randomized controlled trial · n = 281 · 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 L, Boni L, Michelotti A, Gamucci T, Olmeo N, Gori S, Giordano M, Garrone O, Pronzato P, Bighin C, Levaggi A, Giraudi S and 5 more

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Cresti N, Magnolfi E, Scotto T, Vecchio C, Venturini M

JAMA1 Jul 2011Cited by 255 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study1

1 result from studies that gave the peptide. 1 result from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with breast cancer, triptorelin with chemotherapy reduced early menopause versus chemotherapy alone.

    In plain wordsIn premenopausal women with breast cancer, triptorelin with chemotherapy reduced early menopause compared with chemotherapy alone.

    Outcome
    DecreaseEarly menopause at twelve months
    Study

    n = 281

    Comparator
    Chemotherapy alone
    Analysis
    Primary
    Outcome group
    Sex hormones and fertility · Reproductive and sexual health
    Studied dose
    3.75 mg every 4 weeks · intramuscular · Duration of chemotherapyAs given in this study (human).

    Measurements

    Early menopause
    8.9%
    chemotherapy plus triptorelin
    Early menopause
    25.9%
    chemotherapy alone
    Absolute difference
    −17%
    between groups
    Odds ratio
    0.28
    treatment-related early menopause

    Source sentences

    Summary
    Twelve months after the last cycle of chemotherapy (last follow-up, August 18, 2009), the rate of early menopause was 25.9% in the chemotherapy-alone group and 8.9% in the chemotherapy plus triptorelin group, an absolute difference of -17% (95% confidence interval, -26% to -7.9%; P < .001).
    4 context sentences
    Summary · context
    The odds ratio for treatment-related early menopause was 0.28 (95% confidence interval, 0.14 to 0.59; P < .001).
    Summary · context
    The patients were premenopausal women with stage I through III breast cancer who were candidates for adjuvant or neoadjuvant chemotherapy.
    Summary · context
    Before beginning chemotherapy, patients were randomly allocated to receive chemotherapy alone or combined with triptorelin.
    Summary · context
    Triptorelin was administered intramuscularly at a dose of 3.75 mg at least 1 week before the start of chemotherapy and then every 4 weeks for the duration of chemotherapy.

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Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00311636

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

Gruppo Italiano Mammella (GIM)n = 280Sept 2003 to Apr 2008

Breast Cancer

Trial pageClinicalTrials.govUpdated 26 Jun 2013

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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