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Promising targeted therapy for tough breast cancer hits roadblock

NCT ID NCT04251533

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 7 times

Summary

This study tested whether adding the drug alpelisib to standard chemotherapy (nab-paclitaxel) could help people with advanced triple negative breast cancer that has specific genetic changes (PIK3CA mutation or PTEN loss). The trial enrolled 137 participants but was stopped early. The goal was to see if the combination slowed cancer growth or shrank tumors. Because the study was terminated, final conclusions about effectiveness are limited.

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

137 people

The number who actually took part.

Started

Jun 2020

Finished

Feb 2026

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 diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy), or metastatic (stage IV) TNBC * Participant has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present. Part B1: Participants must have measurable disease * Participant has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B1 - PTEN loss or to Part B2 - PTEN loss without a PIK3CA mutation * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participant has received no more than one line of therapy for metastatic disease * Participant has adequate bone marrow and organ function Exclusion Criteria: * Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor * Participant has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients * Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1; with the exception of alopecia * Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening * Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c * Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion * Participant has a history of acute pancreatitis within 1 year prior to screening or past medical history of chronic pancreatitis * Participant has currently documented pneumonitis/interstitial lung disease * Participant has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS) * Participant with unresolved osteonecrosis of the jaw

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

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

Triple negative breast neoplasms

Contacts and locations

Locations

  • Hematology and Oncology Clinic

    Baton Rouge, Louisiana, 70809, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Novartis Investigative Site

    CABA, C1113AAE, Argentina

  • Novartis Investigative Site

    Melbourne, Victoria, 3000, Australia

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009, Australia

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    Leoben, 8700, Austria

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01317-002, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04014-002, Brazil

  • Novartis Investigative Site

    Plovdiv, 4004, Bulgaria

  • Novartis Investigative Site

    Hefei, Anhui, 230001, China

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050011, China

  • Novartis Investigative Site

    Changsha, Hunan, 410013, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029, China

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330009, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Shengyang, Liaoning, 110042, China

  • Novartis Investigative Site

    Shenyang, Liaoning, 110011, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310016, China

  • Novartis Investigative Site

    Dalian, 116000, China

  • Novartis Investigative Site

    Shanghai, 200025, China

  • Novartis Investigative Site

    Tianjin, 300480, China

  • Novartis Investigative Site

    Bogotá, 110221, Colombia

  • Novartis Investigative Site

    Zagreb, 10000, Croatia

  • Novartis Investigative Site

    Saint-Cloud, Hauts De Seine, 92210, France

  • Novartis Investigative Site

    Angers, 49055, France

  • Novartis Investigative Site

    Saint-Herblain, 44805, France

  • Novartis Investigative Site

    Villejuif, 94800, France

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Essen, 45136, Germany

  • Novartis Investigative Site

    Budapest, 1134, Hungary

  • Novartis Investigative Site

    Faridabad, Haryana, 121001, India

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400056, India

  • Novartis Investigative Site

    Vellore, Tamil Nadu, 632004, India

  • Novartis Investigative Site

    Hyderabad, Telangana, 500034, India

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Meldola, FC, 47014, Italy

  • Novartis Investigative Site

    Roma, RM, 00128, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Petaling Jaya, Selangor, 46050, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460, Mexico

  • Novartis Investigative Site

    Oslo, 0407, Norway

  • Novartis Investigative Site

    Trujillo, La Libertad, 13011, Peru

  • Novartis Investigative Site

    Gdynia, 81-519, Poland

  • Novartis Investigative Site

    Opole, 45-061, Poland

  • Novartis Investigative Site

    Poznan, 61-485, Poland

  • Novartis Investigative Site

    Arkhangelsk, 163045, Russia

  • Novartis Investigative Site

    Chelyabinsk, 454048, Russia

  • Novartis Investigative Site

    Moscow, 117997, Russia

  • Novartis Investigative Site

    Moscow, 123056, Russia

  • Novartis Investigative Site

    Saint Petersburg, 196603, Russia

  • Novartis Investigative Site

    Bratislava, 812 50, Slovakia

  • Novartis Investigative Site

    Bratislava, 83310, Slovakia

  • Novartis Investigative Site

    Košice, 041 91, Slovakia

  • Novartis Investigative Site

    Ljubljana, 1000, Slovenia

  • Novartis Investigative Site

    Port Elizabeth, Western Cape, 6045, South Africa

  • Novartis Investigative Site

    Johannesburg, 2196, South Africa

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Seoul, 06351, South Korea

  • Novartis Investigative Site

    Palma, Balearic Islands, 07120, Spain

  • Novartis Investigative Site

    Badajoz, Extremadura, 06080, Spain

  • Novartis Investigative Site

    Alicante, 03010, Spain

  • Novartis Investigative Site

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taipei, 10449, Taiwan

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Kadikoy, 34722, Turkey (Türkiye)

  • Novartis Investigative Site

    Nottingham, NG5 1PB, United Kingdom

  • Novartis Investigative Site

    Oxford, OX3 7LE, United Kingdom

  • Park Nicollet Institute

    Saint Louis Park, Minnesota, 55416, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • University of California LA

    Los Angeles, California, 90095, United States

More trials for these conditions

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