An observational study in Breast Cancer, sponsored by Novartis Pharmaceuticals. Completed at 28 sites in India. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Novartis Pharmaceuticals · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 595 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
PART A: males, post-menopausal women or pre-menopausal women who are receiving ovarian ablation PART B: patients who are PIK3CA mutation positive
PART A:
PART B:
Exclusion Criteria:
PART A:
1. Prior or current enrollment in any interventional clinical trial for ABC/MBC.
Part
PART B:
Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC)/ metastatic breast cancer (MBC) patients
Patients with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) gene mutation positive
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.
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)
Time frame: 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
Time frame: Up to 24 months
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
Time frame: Baseline
PART A: Clinical characteristics of the disease at early (initial) stage of diagnosis- TNM staging
TNM staging will be collected
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
PART A: Clinical characteristics of advanced / metastatic disease stage - number of metastasis
At advanced / metastatic disease diagnosis number of metastasis will be collected
Time frame: Baseline
PART A: Clinical characteristics of advanced / metastatic disease stage - location of metastasis
At advanced / metastatic disease diagnosis location of metastasis will be collected
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
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.
Time frame: Up to 24 months
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
Time frame: Up to 24 months
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.
Time frame: Up to 24 months
PART B: Tolerability of alpelisib plus fulvestrant measured by adverse events (AEs)
Time frame: Up to 24 months
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.
Time frame: Baseline, Up to 24 months
Plan to share: No
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals