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Genetic clues could personalize breast cancer treatment

NCT ID NCT03439046

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study looks at genetic changes in postmenopausal women with a common type of advanced breast cancer (HR+ HER2-). Participants first receive ribociclib plus letrozole; those with a specific mutation (PIK3CA) may later switch to alpelisib plus fulvestrant. The goal is to track how these mutations evolve during treatment and whether they relate to how long the cancer stays under control.

What this could mean

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

Active substance
ribociclib, letrozole, alpelisib, fulvestrant
What this could lead to
If successful, this study could help identify which genetic mutations predict better responses to these targeted therapies, potentially personalizing treatment for advanced breast cancer.
What could go wrong
This is an observational analysis within a treatment study, not a test of new drugs. Results may not change practice if the molecular patterns do not clearly link to outcomes.

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

287 people

The number who actually took part.

Started

Feb 2018

Finished

Dec 2023

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 years and older

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.

CORE PHASE Inclusion Criteria: * Patient has an advanced (locoregionally recurrent or metastatic) breast cancer in first line treatment (treatment naïve for the advanced setting). * Patient is in post-menopause, defined by one of the following: * Prior bilateral oophorectomy * Age ≥60 * Age \<60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range * Patient has a histologically and/or cytologically confirmed diagnosis of estrogenreceptor positive and/or progesterone receptor positive breast cancer by local laboratory. * Patient has an 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. * Patient is willing to undergo blood and tumor sample collection for the biological assessments/objectives as scheduled in the protocol. CORE PHASE Exclusion Criteria: * Patient who received prior treatment with any CDK4/6 inhibitor. * Patient who received any prior systemic hormonal therapy or chemotherapy for advanced breast cancer. Note: Patients who received neo/adjuvant therapy for breast cancer are eligible. If the prior neo/adjuvant therapy included letrozole or anastrozole, the disease-free interval must be greater than 12 months from the completion of treatment until study entry. • Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible. \- Patient is currently using other anti-cancer therapy. Other protocol-defined inclusion/exclusion criteria may apply. EXTENSION PHASE Inclusion criteria: * Patient has been discontinued (any reason allowed) from treatment with ribociclib + letrozole in the core phase and is deemed suitable for treatment with alpelisib + fulvestrant in second line. Ribociclib + letrozole must be the last treatment regimen before alpelisib + fulvestrant. * Patient has PIK3CA mutation as determined in tumor tissue and/or plasma by a Novartis designated laboratory. Results of tissue samples obtained during the core phase (screening or EOT) are acceptable EXTENSION PHASE Exclusion criteria: * Patient has received prior treatment with any PI3K inhibitors. * Patient is concurrently using other anti-cancer therapy. Ribociclib and letrozole used in the core phase must be discontinued at least 7 days prior to day one of the extension study treatment. All drugs with overlapping toxicities must be discontinued within 7 days and AE resolved to NCI CTCAE v4.03 Grade ≤1 prior to study treatment. Exception to this criterion: patients with any grade of alopecia are allowed to enter the study.

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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

  • Novartis Investigative Site

    Casale Monferrato, AL, 15033, Italy

  • Novartis Investigative Site

    Bari, BA, 70124, Italy

  • Novartis Investigative Site

    Bergamo, BG, 24127, Italy

  • Novartis Investigative Site

    Benevento, BN, 82100, Italy

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Brindisi, BR, 72100, Italy

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    Cremona, CR, 26100, Italy

  • Novartis Investigative Site

    Catania, CT, 95123, Italy

  • Novartis Investigative Site

    Catania, CT, 95124, Italy

  • Novartis Investigative Site

    Cona, FE, 44100, Italy

  • Novartis Investigative Site

    San Giovanni Rotondo, FG, 71013, Italy

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Livorno, LI, 57124, Italy

  • Novartis Investigative Site

    Monza, MB, 20900, Italy

  • Novartis Investigative Site

    Province of Macerata, MC, 62100, Italy

  • Novartis Investigative Site

    Messina, ME, 98158, Italy

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Milan, MI, 20141, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Nuoro, NU, 08100, Italy

  • Novartis Investigative Site

    Palermo, PA, 90127, Italy

  • Novartis Investigative Site

    Palermo, PA, 90146, Italy

  • Novartis Investigative Site

    Padova, PD, 35100, Italy

  • Novartis Investigative Site

    Perugia, PG, 06129, Italy

  • Novartis Investigative Site

    Pisa, PI, 56126, Italy

  • Novartis Investigative Site

    Aviano, PN, 33081, Italy

  • Novartis Investigative Site

    Prato, PO, 59100, Italy

  • Novartis Investigative Site

    Fano, PU, 61032, Italy

  • Novartis Investigative Site

    Faenza, RA, 48018, Italy

  • Novartis Investigative Site

    Roma, RM, 00128, Italy

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Roma, RM, 00189, Italy

  • Novartis Investigative Site

    Salerno, SA, 84131, Italy

  • Novartis Investigative Site

    Candiolo, TO, 10060, Italy

  • Novartis Investigative Site

    Torino, TO, 10128, Italy

  • Novartis Investigative Site

    Udine, UD, 33100, Italy

  • Novartis Investigative Site

    Negrar, VR, 37024, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Naples, 80138, Italy

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