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

ClinicalTrials.gov Identifier: NCT05022342

Novartis Reference Number: CBYL719CIN02

Last Update: Jan 12, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Breast Cancer
Phase 
Not Given
Overall status 
Recruiting
Start date 
Oct 27, 2021
Completion date 
Sep 30, 2025
Gender 
All
Age(s)
18 Years - 100 Years (Adult, Older Adult)

Interventions

Other
alpelisib plus fulvestrant
Prospective observational study. There is no treatment allocation. Patients administered alpelisib plus fulvestrant, that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

PART A:

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.

PART B:

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.
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.
Participants with confirmed positive PIK3CA mutation status prior to study entry.
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.
Physician decision to treat patients with alpelisib plus fulvestrant, according to the prescribing label and the local practicing guidelines.
Patient should be alpelisib treatment naïve.

Exclusion Criteria:

PART A:

1. Prior or current enrollment in any interventional clinical trial for ABC/MBC.

Part

PART B:

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.

Study Locations

India
Novartis Investigative Site
Recruiting
Mumbai,
Maharashtra
India
Novartis Investigative Site
Recruiting
Bhubaneshwar, 751007
Orissa
India
Novartis Investigative Site
Recruiting
Kolkata, 700063
West Bengal
India
Novartis Investigative Site
Recruiting
Kolkata, 700016
-
India

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

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