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

NCT ID NCT03822468

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

376 people

The number who actually took part.

Started

Jun 2019

Finished

Aug 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 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.

Key inclusion criteria: * Patient has advanced (loco-regionally recurrent or metastatic) breast cancer not amenable to curative therapy. * Patient has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PgR-positive breast cancer based on the most recently analyzed tissue sample, and all tested by local laboratory. * Patient has 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 and based on the most recently analyzed tissue sample. * Patient must have measurable disease, i.e., at least one measurable lesion according to RECIST version 1.1. (a lesion in a previously irradiated site may only be counted as a target lesion if there is clear evidence of progression since the irradiation). * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the central laboratory: * QTcF interval at screening \< 450 ms (QT interval using Fridericia's correction) * Mean resting heart rate 50 to 90 bpm (determined from the ECG) * Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test (for β-hCG) within 14 days prior to randomization. * Women of CBP must be willing to use highly effective methods of contraception. Key Exclusion Criteria: * Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's judgment. * Patient who received any prior systemic anti-cancer therapy(including endocrine therapy, chemotherapy, prior CDK4/6 inhibitors) for aBC. Patients who received neo-/adjuvant therapy for breast cancer are eligible. * Patient is concurrently using other anti-cancer therapy. * Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major toxicities. * Patient has received extended-field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization, and has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). Patients in whom ≥ * 25% of the bone marrow has been previously irradiated are also excluded. * Patient has a concurrent malignancy or malignancy within 3 years of the randomization date, with the exception of adequately treated basal or squamous cell skin carcinoma, or curatively resected cervical carcinoma in situ. * Patients with central nervous system (CNS) involvement unless they meet specific stability criteria. * Patient has clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality. * Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, and has not fully recovered from side effects of such treatment. Other protocol-defined Inclusion/Exclusion may apply.

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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

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