本研究將評估 inavolisib 聯合 palbociclib 及 fulvestrant 對比安慰劑加 palbociclib 及 fulvestrant 在 PIK3CA 突變、荷爾蒙受體（HR）陽性、HER2 陰性局部晚期或轉移性乳癌患者中的療效、安全性及藥物動力學，該等患者的疾病在輔助荷爾蒙治療期間或完成後 12 個月內出現惡化，且未曾接受過先前全身治療。
適應症：Breast Cancer
收案條件
納入條件
- Confirmed diagnosis of HR+/HER2- breast cancer
- Metastatic or locally advanced disease not amenable to curative therapy
- Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
- Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
- Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
- Consent to provide fresh or archival tumor tissue specimen
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of \> 6 months
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
排除條件
- Metaplastic breast cancer
- Any history of leptomeningeal disease or carcinomatous meningitis
- Any prior systemic therapy for metastatic breast cancer
- Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
- Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible
- Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
- Symptomatic active lung disease, or requiring daily supplemental oxygen
- History of inflammatory bowel disease or active bowel inflammation
- Anti-cancer therapy within 2 weeks before study entry
- Investigational drug(s) within 4 weeks before randomization
- Prior radiotherapy to \>= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
- Chronic corticosteroid therapy or immunosuppressants
- Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 2 weeks after the final dose of study treatment
- Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。