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Genetic clues could personalize breast cancer treatment

NCT ID NCT03439046

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

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.

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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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