Patients with Breast Cancer Previously Treated withEndocrine Therapy
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2022/04/042242
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer.
2. Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor -- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed.
3. Must be deemed appropriate for treatment with endocrine therapy.
4. If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression.
5. Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease).
6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982).
7. Have adequate renal, hematologic, and hepatic organ function.
8. Must be able to swallow capsules/tablets.
1. Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor.
2. Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
3. Have symptomatic or untreated brain metastasis.
4. Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
5. Known allergic reaction against any of the components of the study treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS). Randomization to the date of first documented progression of disease or death from any cause, whichever is earlier. Response Evaluation Criteria in Solid Tumors v1.1 will be applied as the primary criteria for assessment of tumor response and date of tumor progression.Timepoint: Estimated as up to 3 years
- Secondary Outcome Measures
Name Time Method