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Study · Randomized controlled trial · n = 222 · 2016

3 results

Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer.

Noguchi S, Kim HJ, Jesena A, Parmar V, Sato N, Wang HC, Lokejaroenlarb S, Isidro J, Kim KS, Itoh Y, Shin E

Breast cancer (Tokyo, Japan)9 Sept 2015Cited by 34 (Europe PMC)

PMID26350351 (opens in a new tab)PMCIDPMC4999470 (opens in a new tab)DOI10.1007/s12282-015-0637-4 (opens in a new tab)PepBankPUB-26350351
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Summary

BackgroundMonthly goserelin 3.6 mg dosing suppresses estradiol (E2) production and has proven efficacy in pre-menopausal women with estrogen receptor (ER)-positive breast cancer. This non-inferiority study evaluated the efficacy and safety of 3-monthly goserelin 10.8 mg compared with monthly goserelin 3.6 mg.MethodsThis was a Phase 3, open-label, multicenter trial. Pre-menopausal women with ER-positive advanced breast cancer were randomized to 3-monthly goserelin 10.8 mg or monthly goserelin 3.6 mg; all patients received concomitant tamoxifen (20 mg daily). The primary endpoint was progression-free survival (PFS) rate at 24 weeks; non-inferiority was to be confirmed if the entire 95 % confidence interval (CI) for the treatment difference was above -17.5 %. Secondary endpoints included objective response rate (ORR), serum E2 levels, safety, and tolerability.ResultsIn total, 222 patients were randomized (goserelin 10.8 mg, n = 109; goserelin 3.6 mg, n = 113). PFS rate at week 24 was 61.5 % (goserelin 10.8 mg) and 60.2 % (goserelin 3.6 mg); treatment difference (95 % CI) was 1.3 % (-11.4, 13.9), confirming non-inferiority of goserelin 10.8 mg compared with goserelin 3.6 mg. ORR was 23.9 % (goserelin 10.8 mg) and 26.9 % (goserelin 3.6 mg); treatment difference (95 % CI) was -3.0 % (-15.5, 9.7). At week 24, mean serum E2 concentrations were similar in the goserelin 10.8 mg and goserelin 3.6 mg groups (20.3 pg/mL and 24.8 pg/mL, respectively).ConclusionA regimen of 3-monthly goserelin 10.8 mg demonstrated non-inferiority compared with monthly goserelin 3.6 mg for PFS rate at 24 weeks, with similar pharmacodynamic and safety profiles, in pre-menopausal women with ER-positive breast cancer.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In pre-menopausal women with advanced breast cancer, goserelin 10.8 mg was non-inferior to 3.6 mg for progression-free survival: 61.5% versus 60.2%.

    In plain wordsIn women with advanced breast cancer, goserelin every three months was non-inferior to monthly goserelin for progression-free survival.

    Peptide
    Goserelin
    Outcome
    No significant changeProgression-free survival at week 24
    Study

    n = 222

    Comparator
    Goserelin 3.6 mg monthly
    Analysis
    Primary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    10.8 mg every 3 monthsAs given in this study (human).

    Measurements

    PFS rate
    61.5%
    10.8 mg
    PFS rate
    60.2%
    3.6 mg
    Treatment difference
    1.3%
    95% CI -11.4, 13.9

    Source sentences

    Summary
    PFS rate at week 24 was 61.5 % (goserelin 10.8 mg) and 60.2 % (goserelin 3.6 mg); treatment difference (95 % CI) was 1.3 % (-11.4, 13.9), confirming non-inferiority of goserelin 10.8 mg compared with goserelin 3.6 mg.
    1 context sentence
    Summary · context
    Pre-menopausal women with ER-positive advanced breast cancer were randomized to 3-monthly goserelin 10.8 mg or monthly goserelin 3.6 mg; all patients received concomitant tamoxifen (20 mg daily).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In women with advanced breast cancer, objective response was 23.9% with goserelin 10.8 mg versus 26.9% with 3.6 mg; difference -3.0% (95% CI -15.5 to 9.7).

    In plain wordsIn women with advanced breast cancer, response rates were 23.9% with goserelin every three months versus 26.9% with monthly goserelin.

    Peptide
    Goserelin
    Outcome
    DecreaseObjective response rate
    Study

    n = 222

    Comparator
    Goserelin 3.6 mg monthly
    Analysis
    Secondary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    10.8 mg every 3 monthsAs given in this study (human).

    Measurements

    ORR
    23.9%
    10.8 mg
    ORR
    26.9%
    3.6 mg
    Treatment difference
    −3%
    95% CI -15.5, 9.7

    Source sentences

    Summary
    ORR was 23.9 % (goserelin 10.8 mg) and 26.9 % (goserelin 3.6 mg); treatment difference (95 % CI) was -3.0 % (-15.5, 9.7).
    1 context sentence
    Summary · context
    Pre-menopausal women with ER-positive advanced breast cancer were randomized to 3-monthly goserelin 10.8 mg or monthly goserelin 3.6 mg; all patients received concomitant tamoxifen (20 mg daily).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In women with advanced breast cancer, estradiol was similar with goserelin 10.8 mg versus 3.6 mg: 20.3 versus 24.8 pg/mL at week 24.

    In plain wordsIn women with advanced breast cancer, estradiol levels were similar with goserelin every three months and monthly goserelin.

    Peptide
    Goserelin
    Outcome
    No significant changeSerum estradiol at week 24
    Study

    n = 222

    Comparator
    Goserelin 3.6 mg monthly
    Analysis
    Secondary
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    10.8 mg every 3 monthsAs given in this study (human).

    Measurements

    Serum E2
    20.3 pg/mL
    10.8 mg
    Serum E2
    24.8 pg/mL
    3.6 mg

    Source sentences

    Summary
    At week 24, mean serum E2 concentrations were similar in the goserelin 10.8 mg and goserelin 3.6 mg groups (20.3 pg/mL and 24.8 pg/mL, respectively).
    1 context sentence
    Summary · context
    Pre-menopausal women with ER-positive advanced breast cancer were randomized to 3-monthly goserelin 10.8 mg or monthly goserelin 3.6 mg; all patients received concomitant tamoxifen (20 mg daily).

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

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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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