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New drug combo shows promise for Hard-to-Treat breast cancer

NCT ID NCT03056755

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a drug called alpelisib combined with hormone therapy (fulvestrant or letrozole) in 383 people with advanced breast cancer that has a specific genetic change (PIK3CA mutation). The goal was to see how many patients were alive without their cancer getting worse after 6 months. Results showed the combination helped control the cancer for a period of time, but ongoing treatment is needed.

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

383 people

The number who actually took part.

Started

Aug 2017

Finished

Nov 2024

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 99 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.

Key Inclusion Criteria: Subjects eligible for inclusion in the Core Phase of the study fulfilled the following key inclusion criteria: * Subject was an adult male or female ≥ 18 years of age. * Subjects with histologically and/or cytologically confirmed diagnosis of estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive breast cancer by local laboratory. * Subjects with a confirmed human epidermal growth factor receptor-2 (HER2)-negative aBC. * Subjects with gene encoding the p110alpha catalytic subunit of PI3K (phosphatidylinositol-3-kinase) (PIK3CA) mutation. * In case of women, both premenopausal and postmenopausal subjects were allowed to be included in this study. * Subjects with documented evidence of tumor progression on or after: i. Cyclin-Dependent Kinase 4 and 6 inhibitor (CDK4/6i) treatment as last treatment regimen in Cohorts A and B. ii. aromatase inhibitor (AI) treatment (either in adjuvant or metastatic setting) and received systemic chemotherapy or ET (monotherapy or combination except CDK4/6i + AI) as last treatment regimen in Cohort C. Upon completion of enrollment of Cohort B, subjects who received CDK4/6i + fulvestrant as immediate prior therapy were eligible for Cohort C. iii. No more than 2 prior anticancer therapies for aBC. iv. Received no more than 1 prior regimen of chemotherapy for the treatment of advanced/metastatic disease was permitted. v. Recovered to grade 1 or better from any adverse events (AEs) related to previous anticancer therapy prior to study entry (except alopecia or other toxicities not considered a safety risk for the subject at the investigator's discretion). * Subjects with: i. Measurable disease, i.e., at least 1 measurable lesion as per RECIST v1.1 criteria; or ii. If no measurable disease was present, at least 1 predominantly lytic bone lesion had to be present. * Subjects with adequate bone marrow and coagulation function, liver function and renal function as shown by laboratory values. * Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2. Key exclusion criteria were: * Subjects with a known hypersensitivity to alpelisib, fulvestrant, letrozole, goserelin, or leuprolide or to any of their excipients. * Subjects with prior treatment with any PI3K inhibitor (PI3Ki). * Subjects with central nervous system (CNS) involvement unless they met all of the following criteria: i. At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment, ii. Clinically stable CNS tumor at the time of screening untreated or without evidence of progressions for at least 4 weeks after treatment as determined by clinical examination and brain imaging (magnetic resonance imaging (MRI) or computed tomography (CT) during screening period and stable low dose of steroids for 2 weeks prior to initiating study treatment. * Subjects with an established diagnosis of diabetes mellitus type I or uncontrolled type II. * Any concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate subject participation in the study (e.g., chronic active hepatitis, severe hepatic impairment, etc.). * Subjects with a history of noncompliance to medical regimens. * Subjects with impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of the study drugs based on investigator discretion. * Subjects with documented pneumonitis/interstitial lung disease which was active and requiring treatment. * Subjects concurrently using other anticancer therapy. All anticancer therapy had to be discontinued prior to Day 1 of study treatment. * Subjects who had major surgery within 14 days prior to starting treatment with alpelisib, or did not recover from major side effects. * Subjects with significant cardiac abnormalities. * History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis. * Subjects who did not use highly effective contraception while on alpelisib and through the duration after the final dose of alpelisib (not applicable to postmenopausal women). * Subjects with unresolved osteonecrosis of the jaw. Other inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hereditary sensory and autonomic neuropathy 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

  • Advent Health Cancer Institute

    Orlando, Florida, 32804, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • Cancer Care Centers of South Texas HOAST

    San Antonio, Texas, 78229, United States

  • Greater Baltimore Med Center Cancer Center

    Baltimore, Maryland, 21204, United States

  • Josephine Ford Cancer Center

    Detroit, Michigan, 48202, United States

  • Kaiser Permanent Southern Californi

    San Diego, California, 92120, United States

  • Kaiser Permanente Medical Group

    Anaheim, California, 92807, United States

  • Lahey Clinic

    Burlington, Massachusetts, 01805, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Memorial Sloane Ketterin Cancer Ctr

    New York, New York, 10065, United States

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87106, United States

  • Northwest Medical Specialists

    Tacoma, Washington, 98405, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1118AAT, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1125ABD, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1426ANZ, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Novartis Investigative Site

    Rosario, Sante Fe, S200KZE, Argentina

  • Novartis Investigative Site

    La Rioja, 5300, Argentina

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Novartis Investigative Site

    Kitchener, Ontario, N2G 1G3, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5B 1N9, Canada

  • Novartis Investigative Site

    Temuco, Araucania, 4810469, Chile

  • Novartis Investigative Site

    Santiago, 7500921, Chile

  • Novartis Investigative Site

    Santiago, 8420383, Chile

  • Novartis Investigative Site

    Odense C, 5000, Denmark

  • Novartis Investigative Site

    Vejle, DK-7100, Denmark

  • Novartis Investigative Site

    Nice, Alpes Maritimes, 06189, France

  • Novartis Investigative Site

    Saint-Cloud, Hauts De Seine, 92210, France

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Caen, 14021, France

  • Novartis Investigative Site

    Lille, 59020, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Montpellier, 34298, France

  • Novartis Investigative Site

    Saint-Herblain, 44805, France

  • Novartis Investigative Site

    Strasbourg, 67000, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Augsburg, 86150, Germany

  • Novartis Investigative Site

    Berlin, 14169, Germany

  • Novartis Investigative Site

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    Essen, 45136, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Delhi, 110085, India

  • Novartis Investigative Site

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Rehovot, 7661041, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Ancona, AN, 60126, Italy

  • Novartis Investigative Site

    Bergamo, BG, 24127, Italy

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Milan, MI, 20141, Italy

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Osaka, Osaka, 540-0006, Japan

  • Novartis Investigative Site

    Jalisco, 45640, Mexico

  • Novartis Investigative Site

    Maastricht, Limburg, 6229 HX, Netherlands

  • Novartis Investigative Site

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    Singapore, 217562, Singapore

  • Novartis Investigative Site

    Seoul, Korea, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 06351, South Korea

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Salamanca, Castille and León, 37007, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Castellon, 12002, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Tainan, 70403, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taipei, 103616, Taiwan

  • Novartis Investigative Site

    Edinburgh, Scotland, EH4 2XU, United Kingdom

  • Novartis Investigative Site

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    Leicester, LE2 7LG, United Kingdom

  • Novartis Investigative Site

    London, SW3 6JJ, United Kingdom

  • Novartis Investigative Site

    Nottingham, NG5 1PB, United Kingdom

  • St Vincent Frontier Cancer Center

    Billings, Montana, 59102, United States

  • Texas Oncology

    Dallas, Texas, 75246, United States

  • UCSF

    San Francisco, California, 94115, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • Uni Hosp of Cleveland Cancer Center

    Cleveland, Ohio, 44106, United States

  • University of Calif Irvine Med Cntr

    Irvine, California, 92660, United States

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66205, United States

  • University of Louisville James Graham Brown Cancer Center

    Louisville, Kentucky, 40202, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Yale University Yale Cancer Center

    New Haven, Connecticut, 06511, United States

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