New study tracks gene mutations in breast cancer patients on alpelisib

NCT ID NCT05022342

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

Summary

This completed observational study in India enrolled 595 people with HR-positive, HER2-negative advanced or metastatic breast cancer who were already taking alpelisib plus fulvestrant. Researchers looked for PIK3CA gene mutations in tumors and tracked how well the cancer responded to treatment. The goal was to better understand the link between these mutations and patient outcomes.

What this could mean

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

Active substance
alpelisib plus fulvestrant
What this could lead to
If successful, this could help doctors understand which patients with advanced breast cancer might benefit most from alpelisib treatment.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500034, India

  • Novartis Investigative Site

    Guwahati, Assam, 781023, India

  • Novartis Investigative Site

    Kochi, Kerala, 682041, India

  • Novartis Investigative Site

    Bhopal, Madhya Pradesh, 462001, India

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400 012, India

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400071, India

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440001, India

  • Novartis Investigative Site

    Nagpur, Maharashtra, 441108, India

  • Novartis Investigative Site

    Pune, Maharashtra, 411004, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110092, India

  • Novartis Investigative Site

    Bhubaneswar, Odisha, 751003, India

  • Novartis Investigative Site

    Bhubaneswar, Odisha, 751007, India

  • Novartis Investigative Site

    Chandigarh, Punjab, 160055, India

  • Novartis Investigative Site

    Ludhiana, Punjab, 141008, India

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302017, India

  • Novartis Investigative Site

    Sherilingampally, Telangana, 500019, India

  • Novartis Investigative Site

    Howrah, West Bengal, 711103, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700029, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700054, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700063, India

  • Novartis Investigative Site

    Ahmedabad, 380054, India

  • Novartis Investigative Site

    Kanpur, 208002, India

  • Novartis Investigative Site

    Kolkata, 700016, India

  • Novartis Investigative Site

    Kolkata, 700026, India

  • Novartis Investigative Site

    Kolkata, 700107, India

  • Novartis Investigative Site

    Puducherry, 605006, India

  • Novartis Investigative Site

    Udaipur, 313011, India

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