Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women with Breast Cancer, OFS Trial

Status: approved

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.

Inclusion Criteria

Female subject aged ≥ 18 years
Pre- or peri-menopausal patient, who had (1) menses within the 12 months prior to enrollment or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance within the 12 months prior to enrollment
Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for treatment of metastatic breast cancer
Not planning bilateral salpingo-oophorectomy during the 6-month study duration
Completion of chemotherapy, if given. Concurrent use of trastuzumab, pertuzumab, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, cyclin D kinase 4/6 (CDK4/6) inhibitor, and/or phosphoinositide 3-kinase (PI3K) inhibitor therapy is permitted
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

Prior bilateral salpingo-oophorectomy
Pregnant or breast feeding, or plan to become pregnant during the study period
Concomitant use of systemic or transdermal estrogen products
Known allergy or hypersensitivity to goserelin or leuprolide, or any of the excipients in the medications
Unable to take oral medications
Any medical condition that would interfere with the absorption of endocrine therapy. Prior gastric bypass is permitted
Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen

PRIMARY OBJECTIVE:

I. To determine the percentage of participants with ultrasensitive estradiol concentration > 10 pg/ml at least once within 24 weeks after initial gonadotropin releasing hormone agonist (GnRHa) injection, by study arm.

SECONDARY OBJECTIVES:

I. To determine the proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml when assessed 4 weeks after initial GnRHa treatment administration.

II. To determine the proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml at any time when assessed more than 4 weeks after initial GnRHa treatment administration.

III. To determine the change in Functional Assessment of Cancer Therapy (FACT)-Endocrine Subscale (ES) Trial Outcome Index (TOI) over time, by study arm.

IV. To determine the change in FACT-ES Endocrine Symptom Subscale (ESS) over time, by study arm.

V. To determine the percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire the day following initial GnRHa injection, by study arm.

VI. Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire shortly before administration of the second GnRHa injection, by study arm.

VII. To determine the frequency of receipt of GnRHa therapy within ± 1 day of planned dosing (should be given every 28 days).

VIII. To determine the adverse events related to the GnRHa injections during the 24 weeks of the study.

EXPLORATORY OBJECTIVE:

I. To determine whether baseline anti-Mullerian hormone is a predictor of incomplete ovarian suppression.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive lower dose leuprolide intramuscularly (IM) on day 1 of each cycle. 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.

ARM II: Patients receive higher dose leuprolide IM on day 1 of each cycle. 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.

ARM III: Patients receive goserelin subcutaneously (SC) on day 1 of each cycle. 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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Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women with Breast Cancer, OFS Trial

Inclusion Criteria

Exclusion Criteria

United States

Michigan

Ann Arbor

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Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women with Breast Cancer, OFS Trial

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