New drug combo tested for tough breast cancer

NCT ID NCT05631795

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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