癌研連線CancerLink
进行中（不再招募） NCT04191499

评估 Inavolisib + Palbociclib + Fulvestrant 对比安慰剂 + Palbociclib + Fulvestrant 在 PIK3CA 突变、激素受体阳性、HER2 阴性、局部晚期或转移性乳腺癌患者中的疗效与安全性研究

乳腺癌Phase IIIII 期IV 期HER2PIK3CA

本研究将评估 inavolisib 联合 palbociclib 及 fulvestrant 对比安慰剂加 palbociclib 及 fulvestrant 在 PIK3CA 突变、激素受体（HR）阳性、HER2 阴性局部晚期或转移性乳腺癌患者中的疗效、安全性及药物动力学，该等患者的疾病在辅助激素治疗期间或完成后 12 个月内出现恶化，且未曾接受过先前全身治疗。

适应症：Breast Cancer

入组条件

纳入标准

  • 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

排除标准

  • 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

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。