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Breast cancer drug tested in everyday patients

NCT ID NCT05293470

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tracks the safety and effectiveness of Piqray (Alpelisib) in people with a specific type of advanced breast cancer (HR+, HER2-, with a PIK3CA mutation). It includes postmenopausal women and men whose cancer worsened after hormone therapy. Researchers observe patients in real-world settings to see how well the drug works and what side effects occur.

What this could mean

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

Active substance
Alpelisib (Piqray)
What this could lead to
If successful, this study could confirm that Piqray works well and is safe in everyday clinical practice for people with a specific type of advanced breast cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Side effects like high blood sugar or rash are possible.

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

Study facts

What this study's own registry entry says, in plain language.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who are going to receive Piqray per locally approved label are eligible and will be prescribed with Piqray under routine medical practice.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subjects eligible for this study must meet all of the following criteria: 1. Postmenopausal women and men who have a confirmed diagnosis of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer. 2. Patients who have progressed on prior endocrine based therapy and are going to start Piqray treatment for the first time in accordance with the locally approved label. 3. Patients who are willing to provide written informed consent Exclusion Criteria: Subjects eligible for this study must not meet the following criteria: 1. Patients with contraindication according to prescribing information for Piqray in Korea. \- Severe hypersensitivity to Piqray or to any of its components 2. Female subjects who are pregnant and nursing (lactating) 3. Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray. 4. Participants who receive or are going to receive any investigational medicine during surveillance period.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Cheonan Si, Chungcheongnam-do, 31116, South Korea

  • Novartis Investigative Site

    RECRUITING

    Daegu, Dalseo gu, 42602, South Korea

  • Novartis Investigative Site

    RECRUITING

    Goyang-si, Gyeonggi-do, 10475, South Korea

  • Novartis Investigative Site

    RECRUITING

    Suwon, Gyeonggi-do, 16499, South Korea

  • Novartis Investigative Site

    RECRUITING

    Gyeonggi-do, Korea, 11765, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, Korea, 02841, South Korea

  • Novartis Investigative Site

    COMPLETED

    Seoul, Seoul, 06351, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, Seoul, 150-713, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, Yangcheon gu, 07985, South Korea

  • Novartis Investigative Site

    RECRUITING

    Busan, 48108, South Korea

  • Novartis Investigative Site

    RECRUITING

    Busan, 602-030, South Korea

  • Novartis Investigative Site

    RECRUITING

    Daegu, 705 718, South Korea

  • Novartis Investigative Site

    RECRUITING

    Daejeon, 302-241, South Korea

  • Novartis Investigative Site

    RECRUITING

    Jeollanam, 519763, South Korea

  • Novartis Investigative Site

    RECRUITING

    Kyunggi, 425-020, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 04763, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06273, South Korea

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