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Breast cancer drug ribociclib made available Long-Term in new study

NCT ID NCT05161195

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study offers continued access to the targeted cancer drug ribociclib for people with metastatic breast cancer who are already benefiting from it in a previous Novartis trial. About 134 participants will keep taking ribociclib, sometimes with other hormone therapies, while researchers monitor long-term safety and how well the cancer is controlled. The goal is to ensure patients can stay on a treatment that is working for them.

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) taken alone or with other drugs like letrozole, anastrozole, goserelin, or tamoxifen
What this could lead to
If successful, this study could confirm that ribociclib is safe and effective for long-term use in metastatic breast cancer, supporting its continued availability.
What could go wrong
This is a roll-over study, not a new treatment test, so it won't prove whether ribociclib works better than other options. Side effects may still occur with long-term use.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

134 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Aug 2030

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

Anyone

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: * Signed informed consent must be obtained prior to participation in the study. * Participant is currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs and the parent study has fulfilled its primary objective(s). * Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. * Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study. * Participant must have evidence of clinical benefit as determined by the Investigator. Key Exclusion Criteria: * Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol. * Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume). * Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria). * Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment. Highly effective contraception methods include: 1. Total abstinence 2. Female sterilization 3. Male partner sterilization 4. Placement of an intrauterine device (IUD) * Male contraception during ribociclib use by male participants is not required unless it is necessary due to the safety profile of other medications a participant is taking or by local regulations. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer

Contacts and locations

Locations

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • Duly Health and Care

    Plainfield, Illinois, 60585, United States

  • Eastchester Center for Cancer Care

    The Bronx, New York, 10469, United States

  • Englewood Health

    Englewood, New Jersey, 07631, United States

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703, United States

  • Indian Univ Health Goshen Center forCancer

    Goshen, Indiana, 46526, United States

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224, United States

  • John D Archbold Memorial Hospital

    Thomasville, Georgia, 31792, United States

  • Mid Florida Hematology And Onc Ctr

    Orange, Florida, 32763, United States

  • Millennium Research Clin Develop

    Houston, Texas, 77090, United States

  • Northern Light Mercy Hospital

    Portland, Maine, 04102, United States

  • Novartis Investigative Site

    San Juan, J5402DIL, Argentina

  • Novartis Investigative Site

    Natal, Rio Grande do Norte, 59075-740, Brazil

  • Novartis Investigative Site

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Novartis Investigative Site

    Florianópolis, Santa Catarina, 88020-210, Brazil

  • Novartis Investigative Site

    São José do Rio Preto, São Paulo, 15090 000, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01317-000, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 03102-002, Brazil

  • Novartis Investigative Site

    São Paulo, 01255-000, Brazil

  • Novartis Investigative Site

    Chongqing, Chongqing Municipality, 404100, China

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050011, China

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150081, China

  • Novartis Investigative Site

    Changsha, Hunan, 410013, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029, China

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Kunming, Yunnan, 650106, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310016, China

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Qingdao, 266000, China

  • Novartis Investigative Site

    Shanghai, 200025, China

  • Novartis Investigative Site

    Shanghai, 200032, China

  • Novartis Investigative Site

    Tianjin, 300480, China

  • Novartis Investigative Site

    San José, CR, 95008, Costa Rica

  • Novartis Investigative Site

    Heraklion Crete., 715 00, Greece

  • Novartis Investigative Site

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Bhubaneswar, Odisha, 751007, India

  • Novartis Investigative Site

    Delhi, 110085, India

  • Novartis Investigative Site

    Meldola, FC, 47014, Italy

  • Novartis Investigative Site

    Osaka, Osaka, 5400006, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138677, Japan

  • Novartis Investigative Site

    Koto Ku, Tokyo, 1358550, Japan

  • Novartis Investigative Site

    El Chouf, LBN, 1503-2010, Lebanon

  • Novartis Investigative Site

    Beirut, 1100 2070, Lebanon

  • Novartis Investigative Site

    Beirut, 113-0236, Lebanon

  • Novartis Investigative Site

    San Pedro G G, 66278, Mexico

  • Novartis Investigative Site

    Trujillo, La Libertad, 13011, Peru

  • Novartis Investigative Site

    San Borja, Lima region, 15036, Peru

  • Novartis Investigative Site

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    Lisbon, 1400-038, Portugal

  • Novartis Investigative Site

    Loures, 2674-514, Portugal

  • Novartis Investigative Site

    Porto, 4200-072, Portugal

  • Novartis Investigative Site

    Singapore, 119228, Singapore

  • Novartis Investigative Site

    Cape Town, 7500, South Africa

  • Novartis Investigative Site

    Johannesburg, 2196, South Africa

  • Novartis Investigative Site

    Pretoria, 0002, South Africa

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Sant Joan Despí, Barcelona, 08970, Spain

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    Malatya, Battalgazi, 44280, Turkey (Türkiye)

  • Novartis Investigative Site

    Diyarbakır, Sur, 21280, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Novartis Investigative Site

    Kecioren Ankara, 06010, Turkey (Türkiye)

  • Novartis Investigative Site

    Hanoi, 100000, Vietnam

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74136, United States

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80528, United States

  • Summit Cancer Care

    Savannah, Georgia, 31405, United States

  • The Valley Hospital-Luckow Pavillion

    Paramus, New Jersey, 07652, United States

  • University Hospitals of Cleveland Seidman Cancer Center

    Cleveland, Ohio, 44106, United States

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