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Promising drug combo shows progress against advanced breast cancer

NCT ID NCT03671330

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Updated 2 times

Summary

This study tested whether adding the drug ribociclib to standard hormone therapy helps slow the growth of advanced breast cancer in Chinese women. About 327 women with a specific type of breast cancer (HR+, HER2-) took part. The main goal was to see how long the cancer stayed under control. This is not a cure, but aims to manage the disease and delay progression.

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

327 people

The number who actually took part.

Started

Aug 2018

Finished

May 2025

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 60 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.

Inclusion Criteria: * Patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor (ER) positive and/or progesterone receptor positive breast cancer by local laboratory (based on most recently analyzed biopsy). * Patient has HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (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 must have either: * Measurable disease, i.e., at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is a clear sign of progression since the irradiation). OR * If no measurable disease is present, then at least 1 predominantly lytic bone lesion must be present (patients with no measurable disease and only 1 predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation). * Patient has ECOG performance status 0 or 1. For premenopausal cohort: * Patient is an adult, female ≥ 18 years old and \< 60 years old at the time of informed consent and has signed informed consent before any trial related activities are conducted and according to local guidelines. * Confirmed negative serum pregnancy test before starting study treatment or patient has had a hysterectomy. * Patient has advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer not amenable to curative therapy (e.g. surgery and/or radiotherapy). * Patients who received ≤ 14 days of a NSAI (letrozole or anastrozole) with or without goserelin or goserelin ≤ 28 days for advanced breast cancer prior to randomization are eligible. Patients must continue treatment with the same hormonal agent + goserelin during the study. No treatment interruption is required for these patients prior to randomization. * Patients who have received up to 1 line of chemotherapy for advanced breast cancer and have been discontinued 28 days before randomization are eligible. For postmenopausal cohort: * Patient is an adult, female ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. * Women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy. Exclusion Criteria: * Patient who has received a prior CDK4/6 inhibitor. * Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment * Patient with CNS metastases. * Patient who has not had resolution of clinical and laboratory acute toxicities related to prior anti-cancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade ≤1. * Patient has a known history of Human immunodeficiency Virus (HIV) infection (testing not mandatory). * Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality * Patient is currently receiving any of the substances as defined in the protocol that cannot be discontinued 7 days prior to the start of the treatment: For premenopausal cohort: * Pregnant or nursing (lactating) women. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 21 days after stopping study medication. Note: Use of oral (estrogen and progesterone), transdermal, injected or implanted hormonal methods of contraception as well as hormonal replacement therapy is not allowed in this study. For postmenopausal cohort: \- Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and 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 randomization. \- Patients who received ≤ 14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible. 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

  • Novartis Investigative Site

    Hefei, Anhui, 230001, China

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100044, China

  • Novartis Investigative Site

    Chongqing, Chongqing Municipality, 404100, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000, 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

    Nanchang, Jiangxi, 330009, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Shengyang, Liaoning, 110016, China

  • Novartis Investigative Site

    Shengyang, Liaoning, 110042, China

  • Novartis Investigative Site

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, 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

    Fuzhou, 350001, 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

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