Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
Sponsors
Novartis Healthcare Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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. Patientâ??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.
Exclusion criteria
Exclusion criteria: Part A-1. Prior or current enrollment in any interventional clinical trial for ABC/MBC Part B-1. Patientsâ?? 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: PIK3CA mutation is detected (positive or negative) after the enrollment of patient in Part A. Part B:The proportion of patients with a best overall response of complete response or partial disease, or an overall lesion response of stable disease or non-CR/non-PD which lasts for a minimum time duration. This should be evaluated as per RECIST v1.1. This endpoint measures signs of activity considering duration of disease stabilization.Timepoint: Part A: At the Baseline. Part B:At every 3 months up to maximum of 24 months / End-of-Study Visit (EoS) or early discontinuation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A-Demographic and baseline characteristicsTimepoint: Baseline visit;Part-a-Clinical characteristics of the diseaseTimepoint: Baseline visit;Part A-Treatment pattern (Prior therapy)Timepoint: Baseline visit;Part B-Progression free Survival, per RECIST 1.1Timepoint: every 3 months up to maximum of 24 months / End-of-Study Visit (EoS) or early discontinuation;Part B-Overall response rate (ORR)Timepoint: every 3 months up to maximum of 24 months / End-of-Study Visit (EoS) or early discontinuation;Part B-Duration of Response (DoR)Timepoint: every 3 months up to maximum of 24 months / End-of-Study Visit (EoS) or early discontinuation | — |
Countries
India
Contacts
Public ContactDr Disha Shetty
Novartis Healthcare Pvt Limited
Outcome results
None listed