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

What this trial studies

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

Conditions in scope

• Advanced Breast Cancer

Interventions

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

Who can join

All sexes · Ages 18 Years to 100 Years

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

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 12 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE4
• Start date: 2022-08-09
• Primary completion: 2025-06-12
• Last update posted: 2026-04-07
• First posted: 2022-11-30

Sponsor & contact

Lead sponsor: Novartis Pharmaceuticals (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

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)
  Percentage of participants with at least one on-treatment AEs. An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease) in a participant. On-treatment period is defined as up to 30 days after last dose of study drug

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