CTRI/2024/03/063812招募中3 期
A Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Inavolisib in combination with Phesgo versus placebo in combination with Phesgo as maintenance therapy after first line induction therapy in participants with PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer - INAVO
F HoffmannLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •2. Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
- •3. Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
- •4. Confirmation of PIK3CA mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA mutated tumor status
- •5. Disease free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of more than equal to 6 months
- •6. LVEF (left ventricular ejection fraction) of at least 50 percent measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
- •7. Adequate hematologic and organ function prior to initiation of study treatment
- •8. Negative hepatitis B surface antigen (HBsAg) test and negative total hepatitis B core antibody (HBcAb) at screening
- •9. Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test at screening
- •10. Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening
排除标准
- •1. Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K AKT mTOR pathway
- •2. Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
- •3. History or active inflammatory bowel disease
- •4. Disease progression within 6 months of receiving any HER2-targeted therapy
- •5. Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- •6. Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
- •Symptomatic active lung disease, including pneumonitis or interstitial lung disease
- •7. Any history of leptomeningeal disease or carcinomatous meningitis
- •Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
- •8. Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
- •9. Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
- •10. Inability or unwillingness to swallow pills.
- •11. History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. The medical monitor may be consulted if required
- •12. History of prior significant toxicity related to trastuzumab or pertuzumab requiring discontinuation of treatment
- •13. Major surgical procedure, or significant traumatic injury, within 28 days prior to start of study treatment or anticipation of the need for major surgery during the course of study treatment
研究者
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