Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world (NCT05022342) | Clinical Trial Compass
CompletedNot Applicable
Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world
India595 participantsStarted 2021-10-27
Plain-language summary
SPEAR is a non-interventional / observational, prospective, multicenter study planned to be conducted across \~ 30 sites in India, among HR-positive and HER2-negative ABC/MBC patients. This being a non-interventional study, no investigational drug or intervention will be administered as a part of the study participation. All the therapeutic decisions, as well as the type and timing of disease monitoring, laboratory tests or medical procedures will be at the discretion of the treating physician and upon patient's consent. No visits will be scheduled as a part of this non-interventional study, however, data by visits for variables will be collected for all the enrolled patients.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Males (≥18 years of age), post-menopausal\* females or pre-menopausal\*\* females with ovarian ablation (as per physician decision).
✓. Patients with confirmed diagnosis of ABC/MBC (locoregionally recurrent not amenable to curative therapy or metastatic)
✓. 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 \[FISH\])
✓. 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
✓. 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.
✓. Males (≥18 years of age), post-menopausal\* females or pre-menopausal\*\* females with ovarian ablation (as per physician decision).
✓. 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.
✓
What they're measuring
1
PART A: Percentage of patients with tumors harboring a PIK3CA mutation
Timeframe: Baseline
2
PART B: Clinical Benefit Rate (CBR) as measured by RECIST 1.1
. 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.
Exclusion criteria
✕. Patients' who had prior or current exposure to alpelisib or had prior or current exposure to any other PIK3CA inhibitor should be excluded.
✕. Known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant.
✕. Participant with type I or uncontrolled type II diabetes mellitus (HbA1c \>7, \[as per ADA/ACP guidelines 2020\]).
✕. 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).
✕. Participant has documented pneumonitis/interstitial lung disease which is active and requiring treatment.
✕. Participant with unresolved osteonecrosis of the jaw.
✕. 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.