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Breast CancerSPEARNCT05022342

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

An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 28 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Breast Cancer
What is being tested?
alpelisib plus fulvestrant
How many people
595 participants
Where
28 sitesIndia
Study dates
27 Oct 2021to 11 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

India28 sites

  • Novartis Investigative Site

    Ahmedabad, 380054

  • Novartis Investigative Site

    Bhopal, Madhya Pradesh, 462001

  • Novartis Investigative Site

    Bhubaneswar, Odisha, 751003

  • Novartis Investigative Site

    Bhubaneswar, Odisha, 751007

  • Novartis Investigative Site

    Chandigarh, Punjab, 160055

  • Novartis Investigative Site

    Guwahati, Assam, 781023

  • Novartis Investigative Site

    Howrah, West Bengal, 711103

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500034

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302017

  • Novartis Investigative Site

    Kanpur, 208002

  • Novartis Investigative Site

    Kochi, Kerala, 682041

  • Novartis Investigative Site

    Kolkata, West Bengal, 700029

  • Novartis Investigative Site

    Kolkata, West Bengal, 700054

  • Novartis Investigative Site

    Kolkata, West Bengal, 700063

  • Novartis Investigative Site

    Kolkata, 700016

  • Novartis Investigative Site

    Kolkata, 700026

  • Novartis Investigative Site

    Kolkata, 700107

  • Novartis Investigative Site

    Ludhiana, Punjab, 141008

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400 012

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400071

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440001

  • Novartis Investigative Site

    Nagpur, Maharashtra, 441108

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110092

  • Novartis Investigative Site

    Puducherry, 605006

  • Novartis Investigative Site

    Pune, Maharashtra, 411004

  • Novartis Investigative Site

    Sherilingampally, Telangana, 500019

  • Novartis Investigative Site

    Udaipur, 313011

Other trials in India

About this study

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

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.

Read the 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 ABC/MBC 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 ABC/MBC 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 ABC/MBC. 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 patient's 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 physician's discretion and upon patient's consent. The treatment decision by the physician are to be made independent of the patient's 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.

Conditions
Breast Cancer
Being tested
alpelisib plus fulvestrant
Keywords
advanced breast cancer, metastatic breast cancer, PIK3CA mutations
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alpelisib plus fulvestrantOther

    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.

Study groups in NCT05022342
Study groupRoleWhat they receive
HR-positive HER2-negative ABC/MBCHormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC)/ metastatic breast cancer (MBC) patients
PIK3CA mutation positivePatients with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) gene mutation positive
Receives: Other: alpelisib plus fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline

  2. 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

    Measured: Up to 24 months

Secondary outcomes (18)

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

    Two sub-groups will be identified based on age as <75 years and ≥75 years for patient's data collection

    Measured: Baseline

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

    TNM staging will be collected

    Measured: Baseline

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

    Receptor expression can be:

    • ER: Estrogen Receptor
    • PgR: Progesterone Receptor
    • HER2: Human Epidermal Growth Factor Receptor 2

    Measured: Baseline

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

    Disease free interval (DFI) is defined as the interval from the completion of therapy to the diagnosis of recurrence

    Measured: Baseline

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

    At advanced / metastatic disease diagnosis number of metastasis will be collected

    Measured: Baseline

  6. PART A: Clinical characteristics of advanced / metastatic disease stage - location of metastasis

    At advanced / metastatic disease diagnosis location of metastasis will be collected

    Measured: Baseline

  7. PART A: Clinical characteristics of advanced / metastatic disease stage - receptor expression

    Receptor expression can be:

    • ER: Estrogen Receptor
    • PgR: Progesterone Receptor
    • HER2: Human Epidermal Growth Factor Receptor 2

    Measured: Baseline

  8. PART A: Prior number of LoT for the advanced / metastatic disease

    To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, prior number of Line of Therapy (LoT) for the advanced / metastatic disease will be collected

    Measured: Baseline

  9. PART A: Prior treatment type

    To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, prior treatment type (hormone alone, hormone with targeted therapy (TT), chemotherapy, etc.) will be collected

    Measured: Baseline

  10. PART A: Prior treatment sequence by LoT

    To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, prior treatment sequence by Line of Therapy (LoT) will be collected

    Measured: Baseline

  11. PART A: Time to next treatment

    To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, time to next treatment will be collected.

    Time to next treatment: defined as time gap between two Line of Therapy (LoT), as applicable

    Measured: Baseline

  12. PART A: Reason (s) for discontinuation of prior therapy

    To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, reason (s) for discontinuation of prior therapy will be collected

    Measured: Baseline

  13. PART A: PIK3CA mutation positive patients not prescribed alpelisib

    To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, PIK3CA mutation positive patients not prescribed alpelisib will be collected by reason

    Measured: Baseline

  14. PART B: Progression Free Survival (PFS) by RECIST 1.1

    Defined as the time from start of treatment with alpelisib plus fulvestrant (index date) to the date of the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.

    Measured: Up to 24 months

  15. PART B: Overall Response Rate (ORR) by RECIST 1.1

    ORR is defined as the proportion of patients with best overall response of Complete Response (CR) or partial response (PR) evaluated based on local investigator's assessment according to RECIST 1.1

    Measured: Up to 24 months

  16. PARTB: Duration of response (DoR) by RECIST 1.1

    Calculated as the time from the date of the first documented Complete Response (CR) or partial response (PR) per RECIST version 1.1.

    Measured: Up to 24 months

  17. PART B: Tolerability of alpelisib plus fulvestrant measured by adverse events (AEs)

    Measured: Up to 24 months

  18. PART B: Number of patients with laboratory abnormalities

    The laboratory assessment will be recorded at baseline and during the study observation period based on changes in Grade of laboratory abnormality.

    Measured: Baseline, Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2021
  2. Study start27 Oct 2021
  3. Primary completion11 Feb 2025
  4. Study completion11 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
595 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05022342
Sponsor's protocol ID
CBYL719CIN02
Acronym
SPEAR
Status last verified
Feb 2026
First submitted
20 Aug 2021
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 28 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PART A: Percentage of patients with tumors harboring a PIK3CA mutation (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05022342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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