CTRI/2021/10/037292招募中未知
SPEAR (Study of PIK3CA mutations and Effectiveness and tolerability outcomes of Alpelisib in Real-world) A descriptive study of PIK3CA mutations and outcomes with Alpelisib in patients with HR-positive and HER2-negative advanced breast cancer (ABC)/ metastatic breast cancer (MBC) in India - SPEAR
ovartis Healthcare Pvt Limited0 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
- 未知
- 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
- Observational
入排标准
入选标准
- •Part A-1. Males (=18 years of age), post-menopausal females or pre-menopausal females with ovarian ablation (as per physician decision).
- •2. Patients with confirmed diagnosis of ABC/MBC (locoregionally recurrent not amenable to curative therapy or metastatic)
- •3. Patient with histologically and/or cytologically confirmed diagnosis of HR-positive (ER+ and/or PgR+), as well as HER2-negative breast cancer by local laboratory (HER2- by Immunohistochemistry [IHC], for borderline2+ Fluorescence In Situ Hybridization [FISH])
- •4. A separate signed patient ICF for Part A of the study must be obtained prior to any data collection and sample shipment to the central designated laboratory
- •5. Patient’s tumor tissue (archival or fresh) is available to be sent to a central laboratory for PIK3CA testing. In case, tissue sample (archival or fresh) is not available or feasible, liquid biopsy may be allowed.
- •Part B-1 Males (=18 years of age), post-menopausal females or pre-menopausal females with ovarian ablation (as per physician decision).
- •2. Patients with confirmed diagnosis of ABC/MBC (locoregionally recurrent not amenable to curative therapy or metastatic) - for direct enrollment patients into Part B of the study.
- •3. Patient with histologically and/or cytologically confirmed diagnosis of HR-positive (ER+ and/or PgR+), as well as HER2-negative breast cancer by local laboratory (HER2- by Immunohistochemistry [IHC], for borderline2+ Fluorescence In Situ Hybridization [FISH]) - for direct enrollment patients into Part B of the study.
- •4. Participants with confirmed positive PIK3CA mutation status prior to study entry.
- •5. A separate signed ICF for Part B of the study must be obtained by all the patients, prior to any data collection, irrespective of patients who are being enrolled from Part A of the study or who are being enrolled directly into Part B of the study.
- •6. Physician decision to treat patients with alpelisib plus fulvestrant, according to the prescribing label and the local practicing guidelines.
- •7. Patient should be alpelisib treatment naïve.
排除标准
- •Part A-1.Prior or current enrollment in any interventional clinical trial for ABC/MBC
- •Part B-1. Patients’ who had prior or current exposure to alpelisib or had prior or current exposure to any other PIK3CA inhibitor should be excluded.
- •2. Known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant.
- •3. Participant with type I or uncontrolled type II diabetes mellitus (HbA1c >7, [as per ADA/ACP guidelines 2020]).
- •4. Participant has a history of severe cutaneous reactions like Stevens-Johnson-Syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
- •5. Participant has documented pneumonitis/interstitial lung disease which is active and requiring treatment.
- •6. Participant with unresolved osteonecrosis of the jaw.
- •7. Participant reports history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis, major surgery, any relevant medical condition, gastrointestinal (GI) condition preventing absorption, Child Pugh score B or C etc.
研究者
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