Advanced Breast CancerPhase 4ALPINISTNCT05631795
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
A Phase 4 study testing Alpelisib and Fulvestrant in people with Advanced Breast Cancer, run by Novartis Pharmaceuticals at 12 sites in India.
Trial summary
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer (aBC) with a PIK3CA mutation, whose disease had progressed on or after… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Alpelisib and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 12 sitesIndia
- Study dates
- 9 Aug 2022to 12 Jun 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Participants with confirmed PIK3CA mutant advanced or metastatic breast cancer
- Postmenopausal females and males ≥ 18 years old with confirmed HR-positive, HER2-negative advanced or metastatic breast cancer.
- Adequate liver function
- Adequate renal function
- Fasting plasma glucose (FPG) ≤140 mg/dL (7.7 mmol/L) and glycosylated hemoglobin (HbA1c) ≤ 6.4%
- ECOG (Eastern Cooperative Oncology Group) Performance Status < 2
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- Fasting Serum amylase ≤ 2 × ULN and Fasting Serum lipase ≤ ULN
- Potassium within normal limits, or corrected with supplements
- Calcium (corrected for serum albumin) and magnesium within normal limits or ≤ grade 1 if judged clinically not significant by the investigator
Who cannot join
- Known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant
- Participant ineligible for endocrine therapy per the investigator's judgment
- Participant has received prior treatment with any PI3K inhibitors and / or mTOR inhibitor
- Participant with type I diabetes or not controlled type II (based on FPG and HbA1c, see inclusion criterion 6)
- Participant has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer
- Participant has not recovered to grade 1 or better from related side effects of prior anti cancer therapy (with the exception of alopecia)
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- Participants receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry except in cases outlined below: Topical applications, inhaled sprays, eye drops or local injections are allowed. Participants on stable low dose of corticosteroids for at least two weeks prior to enrollment are allowed
- Bilateral diffuse lymphangitic carcinomatosis
- Participants with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required
- Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin and acetylsalicylic acid or equivalent, as long as the INR is ≤2.0)
- Any severe and/ or uncontrolled medical conditions
- Participant with severe liver impairment (Child Pugh score B/C)
- Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
- Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study
- Participant has documented pneumonitis/interstitial lung disease which is active and requiring treatment
- Participant has active cardiac disease or a history of cardiac dysfunction
- Participants with unresolved osteonecrosis of the jaw
- 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 is a nursing (lactating) or pregnant woman
- Participant is a woman of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during study treatment and at least for 1 week (for alpelisib) or 1 year (for fulvestrant based on prescribing label) after the last dose of each study drug (whichever comes later).
- Participant is a sexually active male unwilling to use a condom during intercourse while taking study treatment, and for 1 week (for alpelisib) or 1 year (for fulvestrant based on prescribing label) after stopping each study drug (whichever comes later). A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm during study and up to the time period specified above.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Novartis Investigative Site
Ahmedabad, 380016
Novartis Investigative Site
Bhopal, Madhya Pradesh, 462001
Novartis Investigative Site
Guwahati, Assam, 781016
Novartis Investigative Site
Hyderabad, Telangana, 500004
Novartis Investigative Site
Kolkata, 700026
Novartis Investigative Site
Mumbai, Maharashtra, 400 012
Novartis Investigative Site
Nagpur, Maharashtra, 440001
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110029
Novartis Investigative Site
Pune, Maharashtra, 411040
Novartis Investigative Site
Surat, Gujarat, 395009
Novartis Investigative Site
Thalassery, Kerala, 670103
Novartis Investigative Site
Trivandrum, Kerala, 695 011
About this study
Official title: ALPelisib INdia Safety STudy (ALPINIST): A Phase IV, Prospective, Multicenter, Open-label, Non-comparative, Interventional Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR Positive, HER2-negative, Advanced Breast Cancer (aBC) With a PIK3CA Mutation, Whose Disease Has Progressed on or After Endocrine Based Treatment.
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer (aBC) with a PIK3CA mutation, whose disease had progressed on or after endocrine-based treatment.
Read the detailed description
The study was planned to enroll 40 participants. During the treatment phase, participants were treated with alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and on Day 1 of every cycle thereafter (± 3 days) in a 28-day cycle.
The planned duration of treatment was 6 months. Participants could be discontinued from treatment earlier due to unacceptable toxicity, disease progression, withdrawal of consent, or at the discretion of the investigator or the participant. For participants who were ongoing on treatment at the end of the planned study duration and who, in the opinion of the investigator, were still deriving clinical benefit from alpelisib, every effort was made to continue provision of study treatment via post-trial access (PTA).
- Conditions
- Advanced Breast Cancer
- Being tested
- Alpelisib, Fulvestrant
- Keywords
- HR+, HER2-negative, PI3K, CDK4/6 inhibitor, ER+, PgR+, men, postmenopausal, aromatase inhibitor
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlpelisibDrug
Also called BYL719
Film coated tablet for oral use. Participants will be treated with 300 mg of alpelisib once daily starting on Cycle 1 Day 1
FulvestrantDrug
Injection for intramuscular administration. Participants will be treated with fulvestrant 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Alpelisib + fulvestrant | Experimental | Alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28 day cycle. Receives: Drug: Alpelisib; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least One On-treatment Adverse Events (AEs)
Treatment-Emergent Adverse Events (TEAEs) were defined as the adverse events that occurred, or worsened, during the treatment period (i.e. from the first dose of treatment up to 30 days after the last dose of study drug).
Measured: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months
Secondary outcomes (2)
Percentage of Participants With Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, was a congenital anomaly or birth defect in the offspring of a study participant, or was an abnormal pregnancy outcome.
Measured: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months
Percentage of Participants With Adverse Drug Reactions (ADRs)
An Adverse Drug Reaction (ADR) was defined as an adverse event (AE) that, in the investigator's judgment, was causally suspected to be related to the study treatment.
Measured: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start9 Aug 2022
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631795
- Sponsor's protocol ID
- CBYL719CIN01
- Acronym
- ALPINIST
- Status last verified
- Jul 2026
- First submitted
- 21 Nov 2022
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALPelisib INdia Safety STudy (ALPINIST): A Phase IV, Prospective, Multicenter, Open-label, Non-comparative, Interventional Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR Positive, HER2-negative, Advanced Breast Cancer (aBC) With a PIK3CA Mutation, Whose Disease Has Progressed on or After Endocrine Based Treatment.
- ClinicalTrials.gov ID
- NCT05631795
- Acronym / sponsor ID
- ALPINIST / CBYL719CIN01
- Conditions
- Advanced Breast Cancer
- Keywords
- HR+, HER2-negative, PI3K, CDK4/6 inhibitor, ER+, PgR+, men, postmenopausal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Posted 25 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer (aBC) with a PIK3CA mutation, whose disease had progressed on or after endocrine-based treatment.
Detailed description
The study was planned to enroll 40 participants. During the treatment phase, participants were treated with alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and on Day 1 of every cycle thereafter (± 3 days) in a 28-day cycle.
The planned duration of treatment was 6 months. Participants could be discontinued from treatment earlier due to unacceptable toxicity, disease progression, withdrawal of consent, or at the discretion of the investigator or the participant. For participants who were ongoing on treatment at the end of the planned study duration and who, in the opinion of the investigator, were still deriving clinical benefit from alpelisib, every effort was made to continue provision of study treatment via post-trial access (PTA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpelisib + fulvestrant | Experimental | Drug: Alpelisib, Drug: FulvestrantAlpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant (intramuscular injection) 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28 day cycle. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants with confirmed PIK3CA mutant advanced or metastatic breast cancer
- Postmenopausal females and males ≥ 18 years old with confirmed HR-positive, HER2-negative advanced or metastatic breast cancer.
- Adequate liver function
- Adequate renal function
- Fasting plasma glucose (FPG) ≤140 mg/dL (7.7 mmol/L) and glycosylated hemoglobin (HbA1c) ≤ 6.4%
Key exclusion criteria (21 listed)
- Known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant
- Participant ineligible for endocrine therapy per the investigator's judgment
- Participant has received prior treatment with any PI3K inhibitors and / or mTOR inhibitor
- Participant with type I diabetes or not controlled type II (based on FPG and HbA1c, see inclusion criterion 6)
- Participant has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlpelisibAlso: BYL719Film coated tablet for oral use. Participants will be treated with 300 mg of alpelisib once daily starting on Cycle 1 Day 1 | Drug | Alpelisib + fulvestrant |
| FulvestrantInjection for intramuscular administration. Participants will be treated with fulvestrant 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28-day cycle. | Drug | Alpelisib + fulvestrant |
Primary outcome
Percentage of Participants With at Least One On-treatment Adverse Events (AEs)
Time frame: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months
Treatment-Emergent Adverse Events (TEAEs) were defined as the adverse events that occurred, or worsened, during the treatment period (i.e. from the first dose of treatment up to 30 days after the last dose of study drug).
2 secondary outcomes
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months
Percentage of Participants With Adverse Drug Reactions (ADRs)
Time frame: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alpelisib and Fulvestrant in people with Advanced Breast Cancer, run by Novartis Pharmaceuticals at 12 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 9 inclusion and 21 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With at Least One On-treatment Adverse Events (AEs) (time frame: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.