EUCTR2017-001548-36-PL进行中（未招募）1 期
A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED PHASE III STUDY OF IPATASERTIB IN COMBINATION WITH PACLITAXEL AS A TREATMENT FOR PATIENTS WITH PIK3CA/AKT1/PTEN-ALTERED, LOCALLY ADVANCED OR METASTATIC, TRIPLE-NEGATIVE BREAST CANCER OR HORMONE RECEPTOR–POSITIVE, HER2-NEGATIVE 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
- 450
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
- •General Inclusion Criteria
- •- Woman or man age =>18 years at the time of signing the Informed Consent Form
- •- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •- Adequate hematologic and organ function
- •- Life expectancy of at least 6 months
- •- For women of childbearing potential: agreement to remain abstinent
- •(refrain from heterosexual intercourse) or use contraceptive methods
- •with a failure rate of <1% per year during the treatment period and for
- •at least 28 days after the last dose of Ipat/placebo, 5 months after the
- •last dose of Atezo and 6 months after the last dose of Pac, whichever
- •occurs later, and agreement to refrain from donating eggs during this
- •same period
- •- For men: agreement to remain abstinent (refrain from heterosexual
- •intercourse) or use contraceptive measures, and agreement to refrain
- •from donating sperm during the treatment period and for 28 days after
- •the last dose of ipatasertib or 6 months after the last dose of paclitaxel,
- •whichever occurs later
- •- For any patients enrolled in the extended enrollment phase (i.e.,
- •China extension phase): patient is a current resident of mainland China,
- •Hong Kong, or Taiwan, and of Chinese ancestry
- •Disease-Specific Inclusion Criteria
- •- Locally assessed, histologically documented TNBC or HR+/HER2-
- •adenocarcinoma of the breast that is locally advanced or metastatic and
- •is not amenable to resection with curative intent
- •- Measurable disease according to Response Evaluation Criteria in Solid
- •Tumors (RECIST) v1.1
- •- Eligible for taxane monotherapy
- •- HR+/HER2– breast cancer that is not considered appropriate for
- •endocrine-based therapy and that meets one of the following inclusion
- •o Patient has recurrent disease (locoregional or metastatic) during
- •adjuvant endocrine therapy (i.e. =5 years of being on therapy)
- •o If patient has de novo metastatic disease, patient has progressive
- •disease within 6 months of being on first-line endocrine treatment of
- •metastatic disease.
- •- Submission of a formalin-fixed, paraffin-embedded tumor (FFPE)
- •tissue block or a minimum of 20 freshly cut unstained, serial tumor
- •slides from the most recently collected tumor tissue for central
- •molecular analysis. Cytologic or FNA samples are not acceptable. Tumor
- •tissue from bone metastases that is subject to decalcification is not
- •acceptable.
- •- If the patient already has PIK3CA/AKT1/PTEN alteration results
- •available from the FMI commercial tissue-based NGS assay known as
- •FoundationONE CDx TM, then reduced tissue requirements may be
- •required (upon approval by the Medical Monitor)
- •o This tumor tissue sample is required to be submitted as described
- •above for all patients, i.e., if local assessment of PIK3CA/AKT1/PTEN
- •alteration status or central ctDNA is used to confirm biomarker eligibility
- •tumor tissue is still required to assess alteration status centrally
- •- Confirmation of biomarker eligibility, i.e., valid results from either
- •central testing or local testing (at a CLIA or equivalently accredited
- 另有 7 项未显示
排除标准
- •General Exclusion Criteria:
- •- Inability to comply with study and follow-up procedures-History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills-Active infection requiring systemic anti-microbial treatment (including antibiotics anti-fungals, anti-viral agents)
- •- Known HIV infection and clinically significant history of liver disease
- •consistent with Child-Pugh Class B or C, including active viral or other
- •hepatitis, current drug or alcohol abuse, or cirrhosis-Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the course of the study-New York Heart Association Class II, III, or IV heart failure; left ventricular ejection fraction <50%; or active ventricular arrhythmia requiring medication- Current unstable angina or history of myocardial infarction within 6 months prior to Day 1 of Cycle 1- Congenital long QT syndrome or screening QT interval corrected using Fridericia's formula (QTcF) >480 milliseconds - History or presence of an abnormal ECG that is clinically significant in the investigator's opinion- Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease- Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, may contraindicate the use of an investigational drug
- •Disease-Specific Exclusion Criteria:
- •- History of or known presence of brain or spinal cord metastases, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments
- •- Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2– adenocarcinoma of the breast
- •- Unresolved, clinically significant toxicity from prior therapy
- •- Patients with HR+/HER2– breast cancer, for whom endocrine therapy (alone or with approved targeted therapy such as CDK4/6 inhibitors or everolimus) is considered an appropriate option per local clinical guidelines, i.e., all patients enrolled must not be appropriate candidates for endocrine-based therapy at time of screening
- •- Patients who have received palliative radiation treatment to peripheral sites for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 may be enrolled in the study if they have recovered from all acute, reversible effects (e.g., to Grade 1 or resolved by enrollment)
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites tumorrelated pain, and hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- •- Malignancies other than breast cancer within 5 years prior to Day 1 of
- •Cycle 1 except for appropriately treated carcinoma in situ of the cervix,
- •non melanoma skin carcinoma, or Stage I uterine cancer
- •Ipatasertib-Specific Exclusion Criteria:
- •- History of Type I or Type II diabetes mellitus requiring insulin
- •- Grade >=2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
- •- History of or active inflammatory bowel disease or active bowel inflammation
- •- Lung disease: pneumonitis, inters
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