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New drug combo targets genetic weakness in advanced breast cancer

NCT ID NCT04524000

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This study tests a combination of two drugs—alpelisib (a targeted therapy) and fulvestrant (a hormone blocker)—in Japanese men and postmenopausal women with a specific type of advanced breast cancer (HR+/HER2-) that has a PIK3CA mutation. The cancer must have worsened after prior hormone therapy. The trial has two parts: first to find the safest dose, then to measure how well the combo shrinks tumors. Only 24 participants are enrolled, so results are preliminary.

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 drug) combined with fulvestrant (a hormone therapy)
What this could lead to
If successful, this could provide a new treatment option for Japanese patients with a specific genetic mutation (PIK3CA) whose advanced breast cancer has stopped responding to standard hormone therapy.
What could go wrong
This is a small, early-phase trial (24 participants) focused on safety and dosing, so it is too soon to know if the combination works better than existing options. Side effects from alpelisib, such as high blood sugar and 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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Jan 2021

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: * Japanese man or postmenopausal woman * Participant has adequate tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory. * Participant has identified PIK3CA mutation (as determined by a Novartis designated laboratory) * Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory * Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH or SISH) test is required by local laboratory testing * Participant has measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 * Participant has advanced breast cancer * Participant has ECOG performance status 0 or 1 Exclusion Criteria: * Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the investigator's best judgment * Participant has received prior treatment; * with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor for Cohort 1 and 3 * with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR, AKT inhibitor or CDK 4/6 inhibitor for Cohort 2 * Participant has a known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant * Participant with inflammatory breast cancer at screening * Participant is concurrently using other anti-cancer therapy * Participant has had surgery within 14 days prior to starting study drug or has not recovered from major side effects * Participant with an established diagnosis at screening of diabetes mellitus type I or not controlled type II (based on FPG and HbA1c) * Participant has currently documented pneumonitis /interstitial lung disease * History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis * Participant with unresolved osteonecrosis of the jaw * Participant has a history of severe cutaneous reactions Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

Advanced breast cancer

Contacts and locations

Locations

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4648681, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4668560, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4678602, Japan

  • Novartis Investigative Site

    Kashiwa, Chiba, 2778577, Japan

  • Novartis Investigative Site

    Isehara, Kanagawa, 2591193, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2418515, Japan

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 8608556, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 9808574, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 5400006, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 5418567, Japan

  • Novartis Investigative Site

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138677, Japan

  • Novartis Investigative Site

    Koto Ku, Tokyo, 1358550, Japan

  • Novartis Investigative Site

    Meguro-ku, Tokyo, 1528902, Japan

  • Novartis Investigative Site

    Niigata, 951-8566, Japan

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