Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world

NCT05022342 | Completed

• 1 other identifier: CBYL719CIN02
• Study Type: observational
• Target: 595
• Locations: 1 country
• Sites: 28

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 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.

Conditions

Breast Cancer

Keywords

advanced breast cancer; metastatic breast cancer; PIK3CA mutations

Outcome Measures

Primary Outcomes (2)

• PART A: Percentage of patients with tumors harboring a PIK3CA mutation

  Defined as whether PIK3CA mutation is detected (positive or negative) after the enrollment of patient in Part A of the study. The mutation status should specify each 11 hotspots (C420R, E542K, E545A,E545D, E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y)

  Baseline

• PART B: Clinical Benefit Rate (CBR) as measured by RECIST 1.1

  CBR defined as the proportion of patients with a best overall response of CR (complete response) or PR (partial disease), or an overall lesion response of stable disease (SD) or non-CR/non-PD (progressive disease) which lasts for a minimum time duration (with a default of at least 24 weeks in breast cancer studies). This should be evaluated as per RECIST v1.1. This endpoint measures signs of activity considering duration of disease stabilization

  Up to 24 months

Secondary Outcomes (18)

• PART A: Age at early stage (initial) disease, and advanced/metastatic disease diagnosis

  Baseline

• PART A: Clinical characteristics of the disease at early (initial) stage of diagnosis- TNM staging

  Baseline

• PART A: Clinical characteristics of the disease at early (initial) stage of diagnosis - receptor expression

  Baseline

• PART A: Clinical characteristics of advanced / metastatic disease stage - disease free interval (DFI)

  Baseline

• PART A: Clinical characteristics of advanced / metastatic disease stage - number of metastasis

  Baseline

Study Arms (2)

HR-positive HER2-negative ABC/MBC

Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC)/ metastatic breast cancer (MBC) patients

PIK3CA mutation positive

Patients with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) gene mutation positive

Other: alpelisib plus fulvestrant

Interventions

alpelisib plus fulvestrant OTHER

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.

PIK3CA mutation positive

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PART A: males, post-menopausal women or pre-menopausal women who are receiving ovarian ablation PART B: patients who are PIK3CA mutation positive

You may qualify if:

• 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.

You may not qualify if:

• PART A:
• \. 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

Novartis Investigative Site

Hyderabad, Andhra Pradesh, 500034, India

Location

Novartis Investigative Site

Guwahati, Assam, 781023, India

Location

Novartis Investigative Site

Kochi, Kerala, 682041, India

Location

Novartis Investigative Site

Bhopal, Madhya Pradesh, 462001, India

Location

Novartis Investigative Site

Mumbai, Maharashtra, 400 012, India

Location

Novartis Investigative Site

Mumbai, Maharashtra, 400071, India

Location

Novartis Investigative Site

Nagpur, Maharashtra, 440001, India

Location

Novartis Investigative Site

Nagpur, Maharashtra, 441108, India

Location

Novartis Investigative Site

Pune, Maharashtra, 411004, India

Location

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, 110092, India

Location

Novartis Investigative Site

Bhubaneshwar, Odisha, 751007, India

Location

Novartis Investigative Site

Bhubaneswar, Odisha, 751003, India

Location

Novartis Investigative Site

Chandigarh, Punjab, 160055, India

Location

Novartis Investigative Site

Ludhiana, Punjab, 141008, India

Location

Novartis Investigative Site

Jaipur, Rajasthan, 302017, India

Location

Novartis Investigative Site

Sherilingampally, Telangana, 500019, India

Location

Novartis Investigative Site

Howrah, West Bengal, 711103, India

Location

Novartis Investigative Site

Kolkata, West Bengal, 700029, India

Location

Novartis Investigative Site

Kolkata, West Bengal, 700054, India

Location

Novartis Investigative Site

Kolkata, West Bengal, 700063, India

Location

Novartis Investigative Site

Ahmedabad, 380054, India

Location

Novartis Investigative Site

Kanpur, 208002, India

Location

Novartis Investigative Site

Kolkata, 700016, India

Location

Novartis Investigative Site

Kolkata, 700026, India

Location

Novartis Investigative Site

Kolkata, 700107, India

Location

Novartis Investigative Site

Puducherry, 605006, India

Location

Novartis Investigative Site

Udaipur, 313011, India

Location

Related Links

• Link to study results

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Alpelisib; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: October 27, 2021
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (28)