New drug combo tested for tough breast cancer

NCT ID NCT05631795

Completed Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tested the safety of combining two drugs, alpelisib and fulvestrant, in 40 men and post-menopausal women with a certain type of advanced breast cancer (HR+, HER2-, with a PIK3CA mutation) that had worsened after hormone therapy. The goal was to track side effects. The study is complete, providing safety data for this combination.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: alpelisib and fulvestrant
What this could lead to: If successful, this could confirm a safe treatment option for people with a specific type of advanced breast cancer that has stopped responding to hormone therapy.
What could go wrong: This is a small, completed safety study in India, not designed to prove effectiveness. Side effects like high blood sugar and liver issues are known risks.

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer multiple endocrine neoplasia type 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED BREAST CANCER

Contacts and locations

Locations

Novartis Investigative Site

Guwahati, Assam, 781016, India
Novartis Investigative Site

Surat, Gujarat, 395009, India
Novartis Investigative Site

Thalassery, Kerala, 670103, India
Novartis Investigative Site

Trivandrum, Kerala, 695 011, India
Novartis Investigative Site

Bhopal, Madhya Pradesh, 462001, India
Novartis Investigative Site

Mumbai, Maharashtra, 400 012, India
Novartis Investigative Site

Nagpur, Maharashtra, 440001, India
Novartis Investigative Site

Pune, Maharashtra, 411040, India
Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, 110029, India
Novartis Investigative Site

Hyderabad, Telangana, 500004, India
Novartis Investigative Site

Ahmedabad, 380016, India
Novartis Investigative Site

Kolkata, 700026, India

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