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Could a lower dose of this breast cancer drug be safer and still work?

NCT ID NCT03822468

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a lower starting dose (400 mg) of the targeted drug ribociclib combined with standard hormone therapy (letrozole or anastrozole) in 376 women with advanced hormone receptor-positive, HER2-negative breast cancer. The goal was to see if the lower dose could control the cancer while reducing side effects, especially heart-related ones. Participants had not received prior treatment for advanced disease, and premenopausal women also received goserelin to suppress ovarian function.

What this could mean

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

Active substance

Ribociclib (a targeted cancer drug) combined with anastrozole or letrozole (hormone blockers)

What this could lead to

If successful, this could offer a safer starting dose of ribociclib for controlling advanced breast cancer, potentially reducing heart-related side effects while maintaining effectiveness.

What could go wrong

This is a phase 2 trial, so results are still preliminary. The lower dose might be less effective, and side effects like heart rhythm changes remain a risk.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm 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

  • Comprehensive Cancer Cntr Of Nevada

    Henderson, Nevada, 89052, United States

  • Florida Retina Institute

    Orlando, Florida, 32804, United States

  • Marin Cancer Care

    Greenbrae, California, 94904, United States

  • Millennium Research Clin Develop

    Houston, Texas, 77090, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Mount Sinai School Of Medicine

    New York, New York, 10029, United States

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68154, United States

  • Nebraska Hematology Oncology P C

    Lincoln, Nebraska, 68506, United States

  • New York Oncology Hematology

    Albany, New York, 12208, United States

  • Northwest Medical Specialties

    Tacoma, Washington, 98405, United States

  • Novartis Investigative Site

    San Juan, J5402DIL, Argentina

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    Linz, 4010, Austria

  • Novartis Investigative Site

    Salzburg, 5020, Austria

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Edegem, 2650, Belgium

  • Novartis Investigative Site

    Namur, 5000, Belgium

  • Novartis Investigative Site

    Natal, Rio Grande do Norte, 59075 740, Brazil

  • Novartis Investigative Site

    Florianópolis, Santa Catarina, 88034 000, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01317 000, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04014-002, Brazil

  • Novartis Investigative Site

    Goiânia, 74605-070, Brazil

  • Novartis Investigative Site

    São José do Rio Preto, 15090 000, Brazil

  • Novartis Investigative Site

    Plovdiv, 4004, Bulgaria

  • Novartis Investigative Site

    Sofia, 1303, Bulgaria

  • Novartis Investigative Site

    Sofia, 1756, Bulgaria

  • Novartis Investigative Site

    Cambridge, Ontario, N1R 3G2, Canada

  • Novartis Investigative Site

    Valledupar, Cesar Department, 5602310, Colombia

  • Novartis Investigative Site

    Ibague, Tolima Department, 730006, Colombia

  • Novartis Investigative Site

    Bogotá, 110131, Colombia

  • Novartis Investigative Site

    Bogotá, 110221, Colombia

  • Novartis Investigative Site

    Montería, 230002, Colombia

  • Novartis Investigative Site

    San José, 95008, Costa Rica

  • Novartis Investigative Site

    Brno, Czech Republic, 656 53, Czechia

  • Novartis Investigative Site

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    Helsinki, 00029, Finland

  • Novartis Investigative Site

    Tampere, FIN-33521, Finland

  • Novartis Investigative Site

    Besançon, 25030, France

  • Novartis Investigative Site

    Caen, 14021, France

  • Novartis Investigative Site

    Clermont-Ferrand, 63011, France

  • Novartis Investigative Site

    Lyon 08, 69373, France

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Montpellier, 34298, France

  • Novartis Investigative Site

    Saint-Herblain, 44805, France

  • Novartis Investigative Site

    Strasbourg, F 67085, France

  • Novartis Investigative Site

    Valenciennes, 59300, France

  • Novartis Investigative Site

    Langen, Hesse, 63225, Germany

  • Novartis Investigative Site

    Augsburg, 86150, Germany

  • Novartis Investigative Site

    Berlin, 13581, Germany

  • Novartis Investigative Site

    Bonn, 53111, Germany

  • Novartis Investigative Site

    Dresden, 01127, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Essen, 45136, Germany

  • Novartis Investigative Site

    Tübingen, 72076, Germany

  • Novartis Investigative Site

    Weiden, 92637, Germany

  • Novartis Investigative Site

    Budapest, H 1122, Hungary

  • Novartis Investigative Site

    Debrecen, 4032, Hungary

  • Novartis Investigative Site

    Szolnok, H-5000, Hungary

  • Novartis Investigative Site

    Raipur, Chhattisgarh, 492001, India

  • Novartis Investigative Site

    Nagpur, Maharashtra, 441108, India

  • Novartis Investigative Site

    Bhubaneswar, Odisha, 751007, India

  • Novartis Investigative Site

    Delhii, 110 085, India

  • Novartis Investigative Site

    Mumbai, 400 012, India

  • Novartis Investigative Site

    Amman, 11941, Jordan

  • Novartis Investigative Site

    Kaunas, LTU, LT 50161, Lithuania

  • Novartis Investigative Site

    Vilnius, LT-08660, Lithuania

  • Novartis Investigative Site

    Trujillo, La Libertad, 13011, Peru

  • Novartis Investigative Site

    San Borja, Lima region, 41, Peru

  • Novartis Investigative Site

    San Isidro, Lima region, 27, Peru

  • Novartis Investigative Site

    San Miguel, Lima region, 32, Peru

  • Novartis Investigative Site

    Lisbon, 1400-038, Portugal

  • Novartis Investigative Site

    Loures, 2674514, Portugal

  • Novartis Investigative Site

    Porto, 4200-072, Portugal

  • Novartis Investigative Site

    Arkhangelsk, 163045, Russia

  • Novartis Investigative Site

    Moscow, 111123, Russia

  • Novartis Investigative Site

    Moscow, 115478, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197758, Russia

  • Novartis Investigative Site

    Cape Town, 7500, South Africa

  • Novartis Investigative Site

    Johannesburg, 2196, South Africa

  • Novartis Investigative Site

    Parktown, 2193, South Africa

  • Novartis Investigative Site

    Stockholm, 112 19, Sweden

  • Novartis Investigative Site

    Stockholm, SE-118 83, Sweden

  • Novartis Investigative Site

    Uppsala, 751 85, Sweden

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Rocky Mountain Cancer Centers

    Longmont, Colorado, 80501, United States

  • Southern Cancer Center PC

    Mobile, Alabama, 36608, United States

  • Texas Oncology

    McAllen, Texas, 78503, United States

  • Weinberg Cancer Institute at FSH

    Baltimore, Maryland, 21237-3998, United States