Advanced Breast CancerPhase 2NCT06375707
First-Line Ribociclib Plus Endocrine Therapy Versus Chemotherapy With or Without Subsequent Endocrine Therapy in Patients With Rapidly Progressive HR-Positive/HER2-Negative Advanced Breast Cancer
A Phase 2 study testing Ribociclib in people with Advanced Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This phase II study focuses on women with rapidly progressive hormone receptor-positive and HER2-negative advanced breast cancer, including patients with symptomatic visceral metastases, rapidly increasing tumor burden, impending organ dysfunction, or highly symptomatic non-visceral disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Ribociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2024to 30 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient aged 18 years or older.
- ECOG PS of 0-2.
- Histologically or cytologically confirmed recurrent, metastatic, or unresectable locally advanced breast cancer not amenable to curative surgery or radiotherapy.
- HR-positive/HER2-negative disease: ER expression in at least 10% of tumor-cell nuclei; HER2 IHC 0 or 1+, or IHC 2+ with negative FISH/ISH. When metastatic-tissue pathology is available, the metastatic result is preferred.
- At least one feature of rapid disease progression, as determined by the investigator: symptomatic visceral metastasis; rapidly progressive disease or impending visceral compromise; or markedly symptomatic nonvisceral disease.
- No prior systemic anticancer therapy for recurrent or metastatic disease. Prior neoadjuvant or adjuvant therapy is permitted.
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- At least one measurable lesion according to RECIST 1.1.
- Postmenopausal, premenopausal, or perimenopausal status. Premenopausal or perimenopausal patients must agree to receive OFS.
- Adequate baseline organ function: hemoglobin at least 90 g/L; white blood cell count at least 3.5 × 10^9/L; absolute neutrophil count at least 1.5 × 10^9/L; platelet count at least 100 × 10^9/L; serum creatinine not above the institutional ULN; and clinically acceptable hepatic function.
- Negative pregnancy test for patients of childbearing potential and agreement to use effective contraception according to applicable product information and institutional requirements.
- Written informed consent and ability to comply with treatment and follow-up procedures.
Who cannot join
- Prior systemic anticancer therapy for recurrent or metastatic disease.
- Prior CDK4/6 inhibitor therapy in the neoadjuvant or adjuvant setting.
- Symptomatic central nervous system metastasis requiring urgent local intervention. Treated, clinically stable, asymptomatic CNS metastasis may be permitted at investigator discretion.
- Known contraindication or serious hypersensitivity to ribociclib or the selected endocrine agent.
- Clinically significant uncontrolled cardiac disease, arrhythmia, congenital long-QT syndrome, uncorrected electrolyte abnormality, or baseline QTcF at or above 450 ms.
- Severe or active cardiovascular, hepatic, respiratory, renal, hematologic, infectious, or psychiatric disease that may increase risk or interfere with efficacy assessment.
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- Inability to swallow oral medication or clinically significant gastrointestinal disease that may impair drug absorption.
- Pregnancy or breastfeeding.
- Clinical condition judged by the investigator to preclude safe systemic treatment.
- Any other condition that, in the investigator's opinion, makes participation inappropriate.
- Eligibility for the historical external control cohort
- The external control cohort must satisfy the same core disease, treatment-line, biomarker, rapid-progression, and measurable-disease criteria as the prospective cohort. The following retrospective adaptations are permitted:
- ECOG PS may be taken from an explicit medical-record entry. If functional descriptions are mapped to ECOG PS according to a prespecified rule, the inferred status will be flagged and excluded in sensitivity analyses.
- Rapid disease progression will be determined from contemporaneous symptoms, laboratory findings, imaging descriptions, physician notes, and the treatment-decision context.
- Baseline laboratory values will be the closest available results within the prespecified window before the index chemotherapy date.
- At least one measurable lesion must be retrospectively assessable according to RECIST 1.1. Patients with unavailable or inadequate imaging will be excluded.
- Patients with critically missing baseline covariates, treatment details, tumor-response information, or follow-up outcomes will be excluded according to prespecified data-quality rules.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of First-Line Ribociclib Plus Endocrine Therapy Versus Chemotherapy With or Without Subsequent Endocrine Therapy in Patients With Rapidly Progressive HR-Positive/HER2-Negative Advanced Breast Cancer: A Multicenter, Nonrandomized Phase II Study With an External Control
This phase II study focuses on women with rapidly progressive hormone receptor-positive and HER2-negative advanced breast cancer, including patients with symptomatic visceral metastases, rapidly increasing tumor burden, impending organ dysfunction, or highly symptomatic non-visceral disease. These patients often require prompt and effective systemic treatment.
The purpose of the study is to determine whether first-line ribociclib combined with endocrine therapy can provide effective and rapid tumor control compared with chemotherapy-based treatment. Women in the prospective study group receive ribociclib plus endocrine therapy, with ovarian function suppression when clinically indicated. Their outcomes are compared with data from patients previously treated at the same participating hospitals with combination chemotherapy, with or without subsequent endocrine maintenance therapy.
The main outcome is the objective response rate, defined as the proportion of patients whose tumors shrink or disappear. Other outcomes include progression-free survival, overall survival, clinical benefit, time to response, treatment safety, and quality of life.
Read the detailed description
This study focuses on patients with rapidly progressive hormone receptor-positive, HER2-negative advanced breast cancer, a population for whom prompt systemic disease control is clinically important. Rapid progression may include symptomatic visceral metastases, rapidly increasing tumor burden, impending organ dysfunction, or highly symptomatic non-visceral disease.
The study was initially designed as a prospective, multicenter, randomized phase II trial. Owing to difficulties in prospectively recruiting patients to the chemotherapy control arm, the protocol was amended to include a prospective ribociclib plus endocrine therapy cohort and a retrospective external control cohort. Following statistical consultation, objective response rate was designated as the primary endpoint, with progression-free survival retained as a key secondary endpoint.
Under the amended design, eligible patients receiving first-line ribociclib plus endocrine therapy are enrolled prospectively. Their outcomes are compared with an external control cohort selected from patients treated at the same participating hospitals who received first-line combination chemotherapy, with or without subsequent endocrine maintenance therapy. External control patients are identified from electronic medical records and institutional clinical databases and are required to meet eligibility criteria comparable to those applied to the prospective cohort. The historical control period extends from January 2020 to January 2024.
Objective response rate was designated as the primary endpoint because it directly evaluates early antitumor activity in this phase II setting and was used as the basis for the revised sample-size calculation. Progression-free survival remains a key secondary endpoint. To reduce confounding associated with the nonrandomized external-control design, the study will use predefined eligibility criteria, standardized outcome definitions, and propensity score-based methods, including inverse probability weighting and propensity score matching, with additional multivariable analyses as appropriate.
The major protocol amendment was incorporated into Protocol Version 4.0, dated 28 December 2025, and was approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University on 21 January 2026 under approval number 2023-SR-880.A1.
- Conditions
- Advanced Breast Cancer
- Being tested
- Ribociclib
- Keywords
- HR positive /HER2 negative, Ribociclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibociclibDrug
Also called Anastrozole, Letrozole, Exemestane, Fulvestrant
Ribociclib is administered orally at a dose of 600 mg once daily on Days 1-21 of each 28-day treatment cycle. It is given in combination with investigator-selected endocrine therapy, including anastrozole, letrozole, exemestane, or fulvestrant. Premenopausal or perimenopausal patients also receive ovarian function suppression with goserelin when indicated. Treatment continues until disease progression, unacceptable toxicity, death, withdrawal of consent, or another protocol-defined reason for discontinuation. Dose interruption or reduction is permitted according to protocol-specified toxicity management criteria.
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib combined with ET±OFS | Experimental | Not described Receives: Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Overall response rate (ORR) is defined as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR), as per local review and according to RECIST 1.1.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (8)
Progression Free Survival
Progression-free survival is defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival(OS)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Measured: From date of randomization until the date of death from any cause, assessed up to 100 months
Progression Free Survival2
Refers to the time from randomization to disease progression or death after a patient enters a clinical trial and receives second-line therapy.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Time to treatment failure
Time to treatment failure is defined as the time from the date of randomization/start of treatment to the earliest of date of progression, date of death due to any cause, change to other anti-cancer therapy, or date of discontinuation due to reasons other than 'Protocol violation' or 'Administrative problems'.
Measured: From randomization to treatment failure or withdrawal from the trial; reasons for withdrawal can be patient request, disease progression, death, or adverse events, whichever came first, assessed up to 100 months
Time To Response (TTR)
Time to response is defined as the time from the date of randomization to the first documented response of either CR or PR, which must be subsequently confirmed, as defined by RECIST 1.1.
Measured: From the date of randomization to the first documented response of either CR or PR, whichever came first, assessed up to 100 months
Clinical benefit rate(CBR)
Clinical benefit rate is defined as the proportion of patients with a best overall response of CR, or PR or stable disease, lasting for a duration of at least 24 weeks, as defined by RECIST 1.1.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Change from baseline in the global health status/QOL scale score by using FACT-B questionnaire
Functional Assessment of Cancer Therapy - Breast (FACT-B) will be collected to assess health-related QoL, health status, functioning, disease symptoms, side effects, and cancer-related pain.
Descriptive statistics will be used to summarize the overall score at each scheduled assessment time point. Additionally, change from baseline at the time of each assessment will be summarized.
The distribution of time to definitive 10% deterioration in the global health status from FACT-B questionnaire will be assessed in the two treatment arms. Scores range from 0 to 4. no subscale. 0 score is the worst for social/family and functional wellbeing and 4 is the worst for physical, emotional wellbeing and additional concerns.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Frequency/severity of adverse events, lab abnormalities
Safety of ribociclib in combination with NSAI and OFS, and combination chemotherapies
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start9 Jan 2024
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible participants are prospectively enrolled into a single treatment group receiving first-line ribociclib plus endocrine therapy. Comparative outcomes are assessed using a retrospective, non-concurrent external control cohort of patients previously treated with chemotherapy, with or without subsequent endocrine therapy, at the participating institutions.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Fuyang Cancer Hospital, Affiliated Hospital of Jiangnan University, Jiangyin People's Hospital, Weifang Yidu Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375707
- Sponsor's protocol ID
- HERO-KC23
- Status last verified
- Apr 2024
- First submitted
- 28 Dec 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of First-Line Ribociclib Plus Endocrine Therapy Versus Chemotherapy With or Without Subsequent Endocrine Therapy in Patients With Rapidly Progressive HR-Positive/HER2-Negative Advanced Breast Cancer: A Multicenter, Nonrandomized Phase II Study With an External Control
- ClinicalTrials.gov ID
- NCT06375707
- Acronym / sponsor ID
- HERO-KC23
- Conditions
- Advanced Breast Cancer
- Keywords
- HR positive /HER2 negative, Ribociclib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Fuyang Cancer Hospital, Affiliated Hospital of Jiangnan University, Jiangyin People's Hospital, Weifang Yidu Central Hospital
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II study focuses on women with rapidly progressive hormone receptor-positive and HER2-negative advanced breast cancer, including patients with symptomatic visceral metastases, rapidly increasing tumor burden, impending organ dysfunction, or highly symptomatic non-visceral disease. These patients often require prompt and effective systemic treatment.
The purpose of the study is to determine whether first-line ribociclib combined with endocrine therapy can provide effective and rapid tumor control compared with chemotherapy-based treatment. Women in the prospective study group receive ribociclib plus endocrine therapy, with ovarian function suppression when clinically indicated. Their outcomes are compared with data from patients previously treated at the same participating hospitals with combination chemotherapy, with or without subsequent endocrine maintenance therapy.
The main outcome is the objective response rate, defined as the proportion of patients whose tumors shrink or disappear. Other outcomes include progression-free survival, overall survival, clinical benefit, time to response, treatment safety, and quality of life.
Detailed description
This study focuses on patients with rapidly progressive hormone receptor-positive, HER2-negative advanced breast cancer, a population for whom prompt systemic disease control is clinically important. Rapid progression may include symptomatic visceral metastases, rapidly increasing tumor burden, impending organ dysfunction, or highly symptomatic non-visceral disease.
The study was initially designed as a prospective, multicenter, randomized phase II trial. Owing to difficulties in prospectively recruiting patients to the chemotherapy control arm, the protocol was amended to include a prospective ribociclib plus endocrine therapy cohort and a retrospective external control cohort. Following statistical consultation, objective response rate was designated as the primary endpoint, with progression-free survival retained as a key secondary endpoint.
Under the amended design, eligible patients receiving first-line ribociclib plus endocrine therapy are enrolled prospectively. Their outcomes are compared with an external control cohort selected from patients treated at the same participating hospitals who received first-line combination chemotherapy, with or without subsequent endocrine maintenance therapy. External control patients are identified from electronic medical records and institutional clinical databases and are required to meet eligibility criteria comparable to those applied to the prospective cohort. The historical control period extends from January 2020 to January 2024.
Objective response rate was designated as the primary endpoint because it directly evaluates early antitumor activity in this phase II setting and was used as the basis for the revised sample-size calculation. Progression-free survival remains a key secondary endpoint. To reduce confounding associated with the nonrandomized external-control design, the study will use predefined eligibility criteria, standardized outcome definitions, and propensity score-based methods, including inverse probability weighting and propensity score matching, with additional multivariable analyses as appropriate.
The major protocol amendment was incorporated into Protocol Version 4.0, dated 28 December 2025, and was approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University on 21 January 2026 under approval number 2023-SR-880.A1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible participants are prospectively enrolled into a single treatment group receiving first-line ribociclib plus endocrine therapy. Comparative outcomes are assessed using a retrospective, non-concurrent external control cohort of patients previously treated with chemotherapy, with or without subsequent endocrine therapy, at the participating institutions.
| Arm | Type | Receives |
|---|---|---|
| Ribociclib combined with ET±OFS | Experimental | Drug: Ribociclib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female patient aged 18 years or older.
- ECOG PS of 0-2.
- Histologically or cytologically confirmed recurrent, metastatic, or unresectable locally advanced breast cancer not amenable to curative surgery or radiotherapy.
- HR-positive/HER2-negative disease: ER expression in at least 10% of tumor-cell nuclei; HER2 IHC 0 or 1+, or IHC 2+ with negative FISH/ISH. When metastatic-tissue pathology is available, the metastatic result is preferred.
- At least one feature of rapid disease progression, as determined by the investigator: symptomatic visceral metastasis; rapidly progressive disease or impending visceral compromise; or markedly symptomatic nonvisceral disease.
Key exclusion criteria (17 listed)
- Prior systemic anticancer therapy for recurrent or metastatic disease.
- Prior CDK4/6 inhibitor therapy in the neoadjuvant or adjuvant setting.
- Symptomatic central nervous system metastasis requiring urgent local intervention. Treated, clinically stable, asymptomatic CNS metastasis may be permitted at investigator discretion.
- Known contraindication or serious hypersensitivity to ribociclib or the selected endocrine agent.
- Clinically significant uncontrolled cardiac disease, arrhythmia, congenital long-QT syndrome, uncorrected electrolyte abnormality, or baseline QTcF at or above 450 ms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibociclibAlso: Anastrozole, Letrozole, Exemestane, FulvestrantRibociclib is administered orally at a dose of 600 mg once daily on Days 1-21 of each 28-day treatment cycle. It is given in combination with investigator-selected endocrine therapy, including anastrozole, letrozole, exemestane, or fulvestrant. Premenopausal or perimenopausal patients also receive ovarian function suppression with goserelin when indicated. Treatment continues until disease progression, unacceptable toxicity, death, withdrawal of consent, or another protocol-defined reason for discontinuation. Dose interruption or reduction is permitted according to protocol-specified toxicity management criteria. | Drug | Ribociclib combined with ET±OFS |
Primary outcome
Overall response rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall response rate (ORR) is defined as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR), as per local review and according to RECIST 1.1.
8 secondary outcomes
Progression Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival(OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months
Progression Free Survival2
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Time to treatment failure
Time frame: From randomization to treatment failure or withdrawal from the trial; reasons for withdrawal can be patient request, disease progression, death, or adverse events, whichever came first, assessed up to 100 months
Time To Response (TTR)
Time frame: From the date of randomization to the first documented response of either CR or PR, whichever came first, assessed up to 100 months
Clinical benefit rate(CBR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Change from baseline in the global health status/QOL scale score by using FACT-B questionnaire
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Frequency/severity of adverse events, lab abnormalities
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ribociclib in people with Advanced Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.