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Study · Randomized controlled trial · n = 281 · 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 M, Boni L, Michelotti A, Gamucci T, Scotto T, Gori S, Giordano M, Garrone O, Levaggi A, Poggio F, Giraudi S, Bighin C and 4 more

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Vecchio C, Sertoli MR, Pronzato P, Del Mastro L

JAMA1 Dec 2015Cited by 149 (Europe PMC)

PMID26720025 (opens in a new tab)DOI10.1001/jama.2015.17291 (opens in a new tab)PepBankPUB-26720025
Publisher pagePubMedAsk about this study
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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 study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with breast cancer, triptorelin plus chemotherapy increased menstrual resumption versus chemotherapy alone after age adjustment, but not significantly without adjustment.

    In plain wordsWomen receiving triptorelin plus chemotherapy resumed menstruation more than chemotherapy controls after age adjustment, but the unadjusted difference was not significant.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    MixedMenstrual resumption
    Study

    n = 281

    Comparator
    Chemotherapy alone
    Outcome group
    Sex hormones and fertility · Reproductive and sexual health
    Studied dose
    Dose not stated

    Measurements

    Menstrual resumption
    72.6%
    triptorelin group at 5 years
    Menstrual resumption
    64%
    control at 5 years
    Hazard ratio
    1.28 ratio
    unadjusted
    Hazard ratio
    1.48 ratio
    age-adjusted

    Source sentences

    Summary
    The 5-year cumulative incidence estimate of menstrual resumption was 72.6% (95% CI, 65.7%-80.3%) among the 148 patients in the LHRHa group and 64.0% (95% CI, 56.2%-72.8%) among the 133 patients in the control group (hazard ratio [HR], 1.28 [95% CI, 0.98-1.68]; P = .07; age-adjusted HR, 1.48 [95% CI,…
    4 context sentences
    Summary · context
    Parallel, randomized, open-label, phase 3 superiority trial conducted at 16 Italian sites.
    Summary · context
    Between October 2003 and January 2008, 281 premenopausal women with stage I to III hormone receptor-positive or hormone receptor-negative breast cancer were enrolled.
    Summary · context
    Patients were randomized to receive adjuvant or neoadjuvant chemotherapy alone (control group) or chemotherapy plus triptorelin (LHRHa group).
    Summary · context
    Post hoc end points were long-term ovarian function (evaluated by yearly assessment of menstrual activity and defined as resumed by the occurrence of at least 1 menstrual cycle), pregnancies, and disease-free survival (DFS).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with breast cancer, pregnancy did not significantly differ between triptorelin plus chemotherapy and chemotherapy alone, before or after age adjustment.

    In plain wordsWomen receiving triptorelin plus chemotherapy had no significant pregnancy difference versus chemotherapy alone, before or after age adjustment.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    No significant changePregnancy
    Study

    n = 281

    Comparator
    Chemotherapy alone
    Outcome group
    Sex hormones and fertility · Reproductive and sexual health
    Studied dose
    Dose not stated

    Measurements

    Pregnancy incidence
    2.1%
    triptorelin group at 5 years
    Pregnancy incidence
    1.6%
    control at 5 years
    Hazard ratio
    2.56 ratio
    unadjusted
    Hazard ratio
    2.4 ratio
    age-adjusted

    Source sentences

    Summary
    Eight pregnancies (5-year cumulative incidence estimate of pregnancy, 2.1% [95% CI, 0.7%-6.3%]) occurred in the LHRHa group and 3 (5-year cumulative incidence estimate of pregnancy, 1.6% [95% CI, 0.4%-6.2%]) in the control group (HR, 2.56 [95% CI, 0.68-9.60]; P = .14; age-adjusted HR, 2.40 [95% CI,…
    3 context sentences
    Summary · context
    Parallel, randomized, open-label, phase 3 superiority trial conducted at 16 Italian sites.
    Summary · context
    Between October 2003 and January 2008, 281 premenopausal women with stage I to III hormone receptor-positive or hormone receptor-negative breast cancer were enrolled.
    Summary · context
    Patients were randomized to receive adjuvant or neoadjuvant chemotherapy alone (control group) or chemotherapy plus triptorelin (LHRHa group).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with breast cancer, disease-free survival did not significantly differ between triptorelin plus chemotherapy and chemotherapy alone.

    In plain wordsWomen receiving triptorelin plus chemotherapy had similar disease-free survival to women receiving chemotherapy alone.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    No significant changeDisease-free survival
    Study

    n = 281

    Comparator
    Chemotherapy alone
    Outcome group
    Tumor growth · Cancer
    Studied dose
    Dose not stated

    Measurements

    Disease-free survival
    80.5%
    triptorelin group at five years
    Disease-free survival
    83.7%
    control at five years
    Hazard ratio
    1.17 ratio
    triptorelin versus control

    Source sentences

    Summary
    Five-year DFS was 80.5% (95% CI, 73.1%-86.1%) in the LHRHa group and 83.7% (95% CI, 76.1%-89.1%) in the control group (LHRHa vs control: HR, 1.17 [95% CI, 0.72-1.92]; P = .52).
    3 context sentences
    Summary · context
    Parallel, randomized, open-label, phase 3 superiority trial conducted at 16 Italian sites.
    Summary · context
    Between October 2003 and January 2008, 281 premenopausal women with stage I to III hormone receptor-positive or hormone receptor-negative breast cancer were enrolled.
    Summary · context
    Patients were randomized to receive adjuvant or neoadjuvant chemotherapy alone (control group) or chemotherapy plus triptorelin (LHRHa group).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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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