Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05022342
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2021-08-20
Brief Title:
Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPEAR
Brief 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 ABCMBC 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 patients 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
Detailed Description:
Overall this study will have 2 parts Part A and Part B However it is to be noted that these parts Part A and Part B are independent of each other and can run in parallel The purpose of the Part A of study is to determine the proportion of PIK3CA mutation positive patients among the HR-positive and HER2-negative ABCMBC diagnosed patients in India The Part B of the study aims to evaluate the clinical effectiveness and tolerability of alpelisib plus fulvestrant among men pre-menopausal women ovarian ablation or post-menopausal women who are PIK3CA mutation positive patients with HR-positive and HER2-negative ABCMBC diagnosis among Indian population in the real-world setting
Part A- This will involve enrolling of approximately 1200 patients males post-menopausal women or pre-menopausal women who are receiving ovarian ablation with a documented diagnosis of HR-positive HER2-negative ABCMBC The data on PIK3CA mutation status will be collected only for those patients who signs ICF for participation in the study Once patient signs ICF their samples will be sent for PIK3CA mutation status testing that will be performed at central laboratory and the results on mutation status will be reported to the investigator
Part B- This part aims to enroll approximately 200 patients who are PIK3CA mutation positive The patients enrolled into the Part B of the study can either be continued from Part A of the study or be a direct enrollment into the Part B of the study For the patients entering directly into Part B of the study positive PIK3CA status should be available prior to study entry All the patients entering into part B of the study must be alpelisib treatment naïve The patients enrolled into Part B of the study should have already been planned to receive treatment with alpelisib plus fulvestrant based on their treating physicians discretion and upon patients consent The treatment decision by the physician are to be made independent of the patients inclusion in this observational study During the Part B of the study data by visits for variables will be collected for the enrolled patients at every 3 months interval 1 month if feasible or until a maximum of 24 months observational period or lost to follow-up End-of-study EoS assessment will be performed or death or disease progression whichever occurs first
Part A- This will involve enrolling of approximately 1200 patients males post-menopausal women or pre-menopausal women who are receiving ovarian ablation with a documented diagnosis of HR-positive HER2-negative ABCMBC The data on PIK3CA mutation status will be collected only for those patients who signs ICF for participation in the study Once patient signs ICF their samples will be sent for PIK3CA mutation status testing that will be performed at central laboratory and the results on mutation status will be reported to the investigator
Part B- This part aims to enroll approximately 200 patients who are PIK3CA mutation positive The patients enrolled into the Part B of the study can either be continued from Part A of the study or be a direct enrollment into the Part B of the study For the patients entering directly into Part B of the study positive PIK3CA status should be available prior to study entry All the patients entering into part B of the study must be alpelisib treatment naïve The patients enrolled into Part B of the study should have already been planned to receive treatment with alpelisib plus fulvestrant based on their treating physicians discretion and upon patients consent The treatment decision by the physician are to be made independent of the patients inclusion in this observational study During the Part B of the study data by visits for variables will be collected for the enrolled patients at every 3 months interval 1 month if feasible or until a maximum of 24 months observational period or lost to follow-up End-of-study EoS assessment will be performed or death or disease progression whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None