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New triple therapy aims to halt advanced breast cancer

NCT ID NCT01872260

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a combination of two experimental drugs (LEE011 and BYL719) plus a standard hormone therapy (letrozole) in about 255 women with advanced ER+ breast cancer. The goal is to find safe doses and see if the triple combination can better control the cancer. Participants must have ER+ or PR+ tumors and have had limited prior treatments.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

259 people

The number who actually took part.

Started

Oct 2013

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

Female participants only

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: * Postmenopausal, Estrogen-receptor positive and/or Progesterone-receptor positive breast cancer * Phase Ib dose escalation only: Any number of prior lines of endocrine therapy is allowed with the exception of cytotoxic therapy which is limited to one prior line administered in the advanced (metastatic or locally advanced) setting. * Phase Ib dose expansions Arms 1, 2 and 3 * No prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole for a maximum of one month prior to starting study treatment. * Patients who received (neo)adjuvant therapy for breast cancer are eligible. Prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease-free interval is greater than 12 months from the completion of treatment. Exclusion Criteria: * HER2-overexpression in the patient's tumor tissue * Patients with active CNS or other brain metastases * Major surgery within 2 weeks * Acute or chronic pancreatitis * Bilateral diffuse lymphangitic carcinomatosis * Another malignancy within 3 years * Receiving hormone replacement therapy that cannot be discontinued * Impaired cardiac function * Patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ≥ 126 mg/dL / 7.0 mmol/L or hemoglobin A1c \>6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus. * Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer 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

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Massachusetts General Hospital SC-5

    Boston, Massachusetts, 02114, United States

  • Mays Cancer Ctr Uthsa Mdacc

    San Antonio, Texas, 78229, United States

  • Northwest Medical Specialties

    Tacoma, Washington, 98405, United States

  • Novartis Investigative Site

    Westmead, New South Wales, 2145, Australia

  • Novartis Investigative Site

    Parkville, Victoria, 3050, Australia

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009, Australia

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Saint-Herblain, 44805, France

  • Novartis Investigative Site

    Pisa, PI, 56126, Italy

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28050, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Bellinzona, 6500, Switzerland

  • Novartis Investigative Site

    Glasgow, G12 0YN, United Kingdom

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Texas Oncology

    Amarillo, Texas, 79124, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • Univ of California at San Diego Moores Cancer Ctr

    San Diego, California, 92103, United States

  • Vanderbilt University Medical Ctr

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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