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New pill combo aims to keep advanced breast cancer in check

NCT ID NCT04208178

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 1 time

Summary

This Phase 3 study tests whether adding the targeted drug alpelisib to standard maintenance therapy (trastuzumab and pertuzumab) can help people with advanced HER2-positive breast cancer that has a specific genetic change (PIK3CA mutation) live longer without their cancer growing. The trial enrolls about 19 participants who have already received initial chemotherapy. Part 1 checks the safety of the combination, and Part 2 compares alpelisib against a placebo.

What this could mean

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

Active substance
alpelisib (a targeted cancer pill)
What this could lead to
If successful, this could offer a new maintenance treatment option to help delay cancer progression in people with a specific genetic mutation.
What could go wrong
This is a small, early-phase safety run-in (Part 1) followed by a randomized Phase 3. The drug may cause side effects or not improve outcomes compared to placebo.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

19 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Feb 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.

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: * Participant has histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally not amenable to surgery or is metastatic). * Participant has received pre-study induction therapy with up to and including a maximum of 8 cycles of a taxane (docetaxel, paclitaxel, or nab-paclitaxel), plus trastuzumab and pertuzumab. 4 or 5 cycles of induction therapy are permitted if discontinuation of taxane was due to taxane toxicity. Of note, participants enrolled in Part 1 of this study received 4-6 cycles of pre-study induction therapy. * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Participant has adequate bone marrow and organ function * Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor prior to enrollment, locally confirmed per test listed in protocol or as determined by a Novartis designated central laboratory. Exclusion Criteria: * Participant with inflammatory breast cancer at screening. * Participant with evidence of disease progression during the pre-study induction therapy and prior to first dose of alpelisib (or alpelisib/alpelisib matching-placebo for Part 2) * Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose (FPG) and HbA1c. * Participant has a known history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis * Participant has clinically significant, uncontrolled heart disease and/or recent cardiac events * Participant has a history of Steven-Johnson Syndrome (SJS), erythema multiforme (EM) or Toxic Epidermal Necrolysis (TEN). * Participant has currently documented pneumonitis/interstitial lung disease Other protocol-defined Inclusion/Exclusion may apply.

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Conditions

The condition(s) this trial relates to.

HER2 positive breast carcinoma

As listed by the trial registrant

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

Advanced HER2+breast cancer

Contacts and locations

Locations

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703, United States

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Shanghai, 200032, China

  • Novartis Investigative Site

    Saint-Cloud, Hauts De Seine, 92210, France

  • Novartis Investigative Site

    Saint-Herblain, 44805, France

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • University of California LA

    Los Angeles, California, 90095, United States