Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New study tracks gene mutations in breast cancer patients on alpelisib

NCT ID NCT05022342

Knowledge-focused 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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, 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.

Study facts

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

Participants

595 people

The number who actually took part.

Started

Oct 2021

Finished

Feb 2025

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

PART A: males, post-menopausal women or pre-menopausal women who are receiving ovarian ablation PART B: patients who are PIK3CA mutation positive

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: PART A: 1. Males (≥18 years of age), post-menopausal\* females or pre-menopausal\*\* females with ovarian ablation (as per physician decision). 2. Patients with confirmed diagnosis of ABC/MBC (locoregionally recurrent not amenable to curative therapy or metastatic) 3. Patient with histologically and/or cytologically confirmed diagnosis of HR-positive (ER+ and/or PgR+), as well as HER2-negative breast cancer by local laboratory (HER2- by Immunohistochemistry \[IHC\], for borderline2+ Fluorescence In Situ Hybridization \[FISH\]) 4. A separate signed patient ICF for Part A of the study must be obtained prior to any data collection and sample shipment to the central designated laboratory 5. Patient's tumor tissue (archival or fresh) is available to be sent to a central laboratory for PIK3CA testing. In case, tissue sample (archival or fresh) is not available or feasible, liquid biopsy may be allowed. PART B: 1. Males (≥18 years of age), post-menopausal\* females or pre-menopausal\*\* females with ovarian ablation (as per physician decision). 2. Patients with confirmed diagnosis of ABC/MBC (locoregionally recurrent not amenable to curative therapy or metastatic) - for direct enrollment patients into Part B of the study. 3. Patient with histologically and/or cytologically confirmed diagnosis of HR-positive (ER+ and/or PgR+), as well as HER2-negative breast cancer by local laboratory (HER2- by Immunohistochemistry \[IHC\], for borderline2+ Fluorescence In Situ Hybridization \[FISH\]) - for direct enrollment patients into Part B of the study. 4. Participants with confirmed positive PIK3CA mutation status prior to study entry. 5. A separate signed ICF for Part B of the study must be obtained by all the patients, prior to any data collection, irrespective of patients who are being enrolled from Part A of the study or who are being enrolled directly into Part B of the study. 6. Physician decision to treat patients with alpelisib plus fulvestrant, according to the prescribing label and the local practicing guidelines. 7. Patient should be alpelisib treatment naïve. Exclusion Criteria: PART A: 1\. Prior or current enrollment in any interventional clinical trial for ABC/MBC. Part PART B: 1. Patients' who had prior or current exposure to alpelisib or had prior or current exposure to any other PIK3CA inhibitor should be excluded. 2. Known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant. 3. Participant with type I or uncontrolled type II diabetes mellitus (HbA1c \>7, \[as per ADA/ACP guidelines 2020\]). 4. Participant has a history of severe cutaneous reactions like Stevens-Johnson-Syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). 5. Participant has documented pneumonitis/interstitial lung disease which is active and requiring treatment. 6. Participant with unresolved osteonecrosis of the jaw. 7. Participant reports history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis, major surgery, any relevant medical condition, gastrointestinal (GI) condition preventing absorption, Child Pugh score B or C etc.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.