EUCTR2019-002455-42-FR进行中（未招募）1 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-0077 PLUS PALBOCICLIB AND FULVESTRANT VERSUS PLACEBO PLUS PALBOCICLIB AND FULVESTRANT IN PATIENTS WITH PIK3CA-MUTANT, HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Women or men >= 18 years of age
- •- Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
- •- Confirmed diagnosis of HR+/HER2– breast cancer
- •- Metastatic or Locally Advanced disease not amenable to curative therapy
- •- Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
- •- Consent to provide fresh or archival tumor tissue specimen
- •- Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
- •- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1; bone-only” disease, even if considered measurable, is not 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
- •- Ability, in the investigator’s judgment, and willingness to comply with all study-related procedures, including completion of patient-reported endpoints
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
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
- •- 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
- •- Inability or unwillingness to swallow pills or receive intramuscular injections
- •- Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases are eligible
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites
- •- 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 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
- •- History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- •- History of or active clinically significant cardiovascular dysfunction
- •- Chronic corticosteroid therapy or immunosuppressants
- •- Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
- •- Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1
研究者
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