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Trial eligibility change
| eligibility_criteria | Inclusion Criteria: * Female (assigned at birth), ≥18 years old, and able to provide informed consent * Histologically confirmed metastatic or locally advanced breast cancer * Postmenopausal status defined by surgical or natural menopause, or ovarian suppression with a GnRH agonist * Prior treatment including at least one endocrine therapy in the metastatic setting, at least one CDK4/6 inhibitor (in the adjuvant and/or metastatic setting), and no more than two prior cytotoxic regimens in the metastatic setting * Radiologic disease progression on the most recent therapy * Measurable disease per RECIST v1.1 * Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate * ER-positive and HER2-negative status documented within 2 years * ECOG performance status 0-1 and life expectancy of at least 3 months * Adequate organ function Recovery from prior therapy-related toxicities to Grade ≤1 (except alopecia; neuropathy and endocrinopathies ≤Grade 2) * Ability to swallow oral medication and comply with study procedures * Stable dose (≥30 days) of bisphosphonates or denosumab, if applicable Exclusion Criteria: * Inflammatory breast cancer or known brain metastases * Recent major bleeding or uncontrolled bleeding disorder * Ongoing corticosteroid use \>10 mg/day (prednisone equivalent) * Recent anticancer or investigational therapy within 14 days (28 days for fulvestrant) * Untreated or unstable spinal cord compression * Significant cardiovascular disease within 6 months or ongoing uncontrolled cardiac conditions * Active or uncontrolled infection (controlled HIV or treated hepatitis C allowed) * Uncontrolled renal, pancreatic, or liver disease (excluding stable conditions such as Gilbert's syndrome or liver metastases) * Another malignancy requiring treatment within 2 years (except low-risk, curatively treated cancers) * Major surgery within 28 days * Any condition that may interfere with safety or study compliance * Pregnancy or breastfeeding | → | Inclusion Criteria: * Female (assigned at birth), greater than or equal to (\>=) 18 years old, and able to provide informed consent * Histologically confirmed metastatic or locally advanced breast cancer * Postmenopausal status defined by surgical or natural menopause, or ovarian suppression with a GnRH agonist * Prior therapy including 1. Must have received at least one endocrine therapy in the metastatic setting. 2. Must have received at least one cyclin-dependent kinase (CDK) 4/6i, either in the adjuvant and/or metastatic setting. 3. For Part 1 and Part 2 Cohorts 2A, 2B, 2C, and 2D: Participants may have received up to two prior distinct cytotoxic regimens (for example, taxanes, antibody-drug conjugates (ADCs), etc.) in the metastatic setting, unless discussed and approved by the medical monitor. 4. For Part 2 Cohort 2E: Participants must have received more than two prior distinct cytotoxic regimens (for example, taxanes, ADCs, etc.) in the metastatic setting. * Radiologic disease progression on the most recent therapy * Patients must have disease evaluable per response evaluation criteria in solid tumors (RECIST) v1.1 1. For Part 1 and Part 2B, 2C, and 2E: Participants may have either evaluable or measurable disease per RECIST v1.1. 2. For Part 2 Cohort 2A: Participants should have measurable soft tissue disease per RECIST v1.1. 3. For Part 2 Cohort 2D: Participants should have evaluable but not measurable disease. * Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate * For Part 1 and Part 2 (all cohorts): 1. Participants must have documented \>=10% ER staining and human epidermal growth factor receptor 2 (HER2) negative (per american society of clinical oncology \[ASCO\] college of american pathologists \[CAP\] guidelines) on the most recent tumor biopsy sample obtained. 2. For Part 2 Cohort 2B: Participants must have recent estrogen receptor 1 gene (ESR1) wild type from tumor or circulating tumor deoxy ribonucleic acid (ctDNA) testing performed after the most recent endocrine therapy prior to enrollment. 3. For Part 2 Cohort 2C: Participants must have ESR1 mutation detected from tumor or ctDNA testing performed prior to enrollment. * Eastern cooperative oncology group (ECOG) performance status 0-1 and life expectancy of at least 3 months * Adequate organ function Recovery from prior therapy-related toxicities to Grade \<=1 (except alopecia; neuropathy and endocrinopathies \<=Grade 2) * Ability to swallow oral medication and comply with study procedures * Stable dose (\>=30 days) of bisphosphonates or denosumab, if applicable Exclusion Criteria: * Participants with Inflammatory breast cancer or leptomeningeal disease or brain metastases, with the exception of patients with definitively treated brain metastases that are clinically stable and asymptomatic for \>2 weeks and who are off or receiving low-dose corticosteroid treatment (\<=10 mg prednisone or equivalent) for at least 2 weeks prior to start of study treatment. * Recent major bleeding or uncontrolled bleeding disorder * Ongoing corticosteroid use \>10 mg/day (prednisone equivalent) * Recent anticancer or investigational therapy within 14 days (28 days for fulvestrant) * Untreated or unstable spinal cord compression * Significant cardiovascular disease within 6 months or ongoing uncontrolled cardiac conditions * Active or uncontrolled infection (controlled HIV or treated hepatitis C allowed) * Uncontrolled renal, pancreatic, or liver disease (excluding stable conditions such as Gilbert's syndrome or liver metastases) * Another malignancy requiring treatment within 2 years (except low-risk, curatively treated cancers) * Major surgery within 28 days * Any condition that may interfere with safety or study compliance * Pregnancy or breastfeeding |
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