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.

Plain English Summary

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 is a Phase 4 clinical trial sponsored by Novartis Pharmaceuticals studying Advanced Breast Cancer. This study tests the safety of a combination treatment (alpelisib and fulvestrant) for advanced breast cancer. It is for men and post-menopausal women with a specific type of breast cancer (HR-positive, HER2-negative) that has a PIK3CA mutation and has progressed after prior endocrine therapy. Participants will receive alpelisib daily and fulvestrant injections. The study is open-label, meaning both patients and doctors know which treatments are being given. Alternative treatments may include other targeted therapies, chemotherapy, or participation in other clinical trials, depending on the patient's specific situation and doctor's recommendation. The trial aims to enroll 40 participants.

Official Summary

The purpose of this study is to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with HR-positive, HER2-negative, advanced or metastatic breast cancer (aBC) with a PIK3CA mutation, whose disease has progressed on or after endocrine-based treatment

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are a man or a post-menopausal woman aged 18 or older with HR-positive, HER2-negative advanced breast cancer that has a PIK3CA mutation and has not responded to previous endocrine treatment. You cannot join if you have a known allergy to alpelisib or fulvestrant, have received certain prior cancer treatments (like PI3K inhibitors), have uncontrolled diabetes, or have certain other severe medical conditions. Your liver and kidney function must be adequate, and your blood sugar levels (fasting plasma glucose and HbA1c) must be within specific limits. You must have a good general health status (ECOG performance status < 2) and normal levels for certain blood tests (amylase, lipase, potassium, calcium, magnesium). This trial is studying Advanced Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures the percentage of participants who experience any side effects while on the study treatment, helping doctors understand how well the combination is tolerated. The specific primary outcome measures are: Percentage of participants with at least one on-treatment adverse events (AEs) (From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial addresses a need for safe and effective treatments for a specific subset of advanced breast cancer patients whose disease has progressed despite standard endocrine therapy, particularly tho This research targets Advanced Breast Cancer, where improved treatment options are needed.

Investor Insight

This Phase IV study by Novartis aims to gather more safety data on alpelisib in combination with fulvestrant, a common treatment for HR+/HER2- advanced breast cancer, potentially supporting its contin This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor about the potential side effects of alpelisib and fulvestrant, and how they will be monitored. Understand how often you will need to visit the clinic for assessments and treatment administration. Discuss any other medications or supplements you are taking to ensure they don't interfere with the study drugs. The trial is being conducted at 12 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 40 participants

Interventions

• DRUG: Alpelisib — Film coated tablet for oral use. Participants will be treated with 300 mg of alpelisib once daily starting on Cycle 1 Day 1
• DRUG: Fulvestrant — 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.

Primary Outcomes

• Percentage of participants with at least one on-treatment adverse events (AEs) (From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months)

Secondary Outcomes

• Percentage of participants with Serious AEs (SAEs) (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) (From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months)

Full Eligibility Criteria

Key Inclusion Criteria:

* 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
* 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

Key Exclusion Criteria:

* 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)
* 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

• Novartis Investigative Site, Guwahati, Assam, India
• Novartis Investigative Site, Surat, Gujarat, India
• Novartis Investigative Site, Thalassery, Kerala, India
• Novartis Investigative Site, Trivandrum, Kerala, India
• Novartis Investigative Site, Bhopal, Madhya Pradesh, India
• Novartis Investigative Site, Mumbai, Maharashtra, India
• Novartis Investigative Site, Nagpur, Maharashtra, India
• Novartis Investigative Site, Pune, Maharashtra, India
• Novartis Investigative Site, New Delhi, National Capital Territory of Delhi, India
• Novartis Investigative Site, Hyderabad, Telangana, India
• ...and 2 more locations

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Advanced Breast Cancer
• Metastatic Breast Cancer
• Hormone Receptor-Positive Breast Cancer
• HER2-Negative Breast Cancer
• PIK3CA-Mutated Breast Cancer
• Endocrine Therapy Resistance
• Oncology
• Targeted Therapy
• Women's Health

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