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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-03933 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HUM00270281 | Other Identifier | University of Michigan |
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This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. Both doses of leuprolide may be as safe, tolerable and/or effective as goserelin in suppressing ovarian function in pre- or peri-menopausal women with breast cancer.
13MAY2026- New Amendment approved which made the following changes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (leuprolide) | Experimental | Leuprolide 3.75 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study. |
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| Arm II (leuprolide) | Experimental | Leuprolide 7.5 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study. |
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| Arm III (goserelin) | Experimental | Goserelin 3.6 mg q4 weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml | Analyses will primarily be descriptive reporting the overall and by treatment group proportions of women with ultrasensitive estradiol concentration and the corresponding exact binomial 95% confidence intervals over the first 24 weeks of gonadotropin releasing hormone agonist (GnRHa) therapy. | During the first 24 weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml | Will be described with corresponding 95% confidence intervals overall and by treatment group. | At 4 weeks after initial GnRHa treatment administration |
| Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cancer AnswerLine | Contact | 1-800-865-1125 | CancerAnswerLine@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Norah L Henry | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Recruiting | Ann Arbor | Michigan | 48109 | United States |
participant demographics, estradiol concentrations, and patient-reported outcomes data will be available to researchers upon reasonable request
researchers can request data once the primary analysis has been published
deidentified data will be available to researchers upon reasonable request
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| Electronic Health Record Review | Other | Ancillary studies |
|
| Goserelin | Drug | Given SC |
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| Leuprolide | Drug | Given IM |
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| Questionnaire Administration | Other | Ancillary studies |
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Will be described with corresponding 95% confidence intervals overall and by treatment group. |
| Any time after 4 weeks of initial GnRHa treatment administration, assessed cycle 3 day 1-cycle 7 day 1 (cycle length = 28 days) |
| Change in Functional Assessment of Cancer Therapy-(FACT)-Endocrine Subscale (ES) Trial Outcome Index | Will use linear mixed-effects models with fixed effects for study group, time, and their interaction. For each outcome, a random intercept for each participant will be included to account for within-subject correlation. This approach allows for estimation of longitudinal trends in FACT-ES scores and assessment of whether changes over time differ between treatment arms. Missing data will be handled using maximum likelihood estimation under the assumption of missing at random (MAR). | Up to 24 weeks |
| Change in FACT-ES Endocrine Symptom Subscale | Will use linear mixed-effects models with fixed effects for study group, time, and their interaction. For each outcome, a random intercept for each participant will be included to account for within-subject correlation. This approach allows for estimation of longitudinal trends in FACT-ES scores and assessment of whether changes over time differ between treatment arms. Missing data will be handled using maximum likelihood estimation under the assumption of MAR. | Up to 24 weeks |
| Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire | Will be described by study arm and with corresponding exact binomial 95% confidence intervals. | At the day following initial GnRHa injection |
| Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire | Will be described by study arm and with corresponding exact binomial 95% confidence intervals. | Before administration of the second GnRHa injection |
| Receipt of GnRHa therapy within ± 1 day of planned dosing | Planned dosing should be given every 28 days. The proportion of patients who receive GnRHa therapy within ± 1 day of planned dosing will be reported overall and by study arm with corresponding exact binomial 95% confidence intervals. | Up to 24 weeks |
| Incidence of adverse events (AEs) | AEs will be graded and described using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will be reported using descriptive statistics for each GnRHa study arm. | Up to 24 weeks |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D017273 | Goserelin |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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