Breast CancerPhase 3NCT07400523
Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy
A Phase 3 study testing Ribociclib plus aromatase inhibitor and Aromatase inhibitor in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.
Trial summary
This is a multi-center, open-lable, prospective, randomized phase III clinical trial to investigate the efficacy and safety of adjuvant ribociclib combined with aromatase inhibitor in hormone receptor-positive, HER2-negative early breast cancer with residual disease after neoadjuvant chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ribociclib plus aromatase inhibitor and Aromatase inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 4 sitesChina
- Study dates
- 10 Feb 2026to 10 Feb 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Willingness for study participation with written informed consent
- Female with age at least 18 years
- Histologically confirmed unilateral or bilateral primary invasive breast cancer
- Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion
- Histologically confirmed hormone receptor-positive (≥1% ER and/or PR positive stained cells) and HER2-negative (IHC 2+ with FISH-negative or IHC 0-1+) assessed preferably on core biopsy of the breast or tissue from post-neoadjuvant residual invasive disease, or if no other tissue is available the residual tumor of the lymph node can be assessed. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable
- Histologically confirmed Ki67 expression assessed preferably on core biopsy or post-neoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable
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- QTc interval < 450 msec with mean resting heart rate 50-99 beats/min (determined by ECG)
- Patients must have received neoadjuvant chemotherapy of at least 18 weeks. This period must include 6 weeks of a taxane-containing neoadjuvant therapy (Exception: For patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant treatment, a total treatment period of less than 18 weeks is also eligible)
- Adequate surgical treatment including resection of all clinically evident disease and ipsilateral axillary lymph node dissection. Histologically complete resection (R0) of the invasive and ductal in situ tumor is required in case of breast conserving surgery as the final treatment. No evidence of gross residual disease (R2) is required after total mastectomy (R1 resection is acceptable). Axillary dissection is not required in patients with a negative sentinel-node biopsy before (pN0, pN+[mic]) or after (ypN0, ypN+[mic]) neoadjuvant chemotherapy
- Less than 16 weeks interval since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) at date of randomization
- Completion of adjuvant radiotherapy according to standard guidelines (e.g. NCCN) is strongly recommended. If radiotherapy is not performed the reason for this needs to be documented in the eCRF
- No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy. Local progression during chemotherapy is not an exclusion criterion
- c/pT3N0; c/pT2N0 with MammaPrint high-risk, G3, G2+Ki67 ≥20%, or lymphovascular invasion
- Eastern Cooperative Oncology Group performance status 0 or 1
- Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade ≤1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion)
- Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer
- The patient must be accessible for scheduled visits, treatment and follow-up. Patients registered on this trial must be treated at the participating center which could be the Principal or a Co- investigator's site
Who cannot join
- c/pN+
- Known severe hypersensitivity reactions to compounds similar to ribociclib or to aromatase inhibitor
- Inadequate organ function immediate prior to randomization including: Hemoglobin <10g/dL (100g/L); ANC < 2000/mm³ (< 2.0 x 10^9/L); Platelets <100,000/mm³ (< 100 x 10^9/L); AST or ALT >1.5 x upper limit of normal (ULN); alkaline phosphatase > 2.5 x ULN, total serum bilirubin > 1.25 x ULN; serum creatinine >1.25 x ULN or estimated creatinine clearance < 60 mL/min as calculated using the method standard for the institution; severe and relevant co-morbidity that would interact with the participation in the study
- Evidence for infection including wound infections, Human Immunodeficiency Virus (HIV) or any type of Hepatitis
- The cumulative dose of doxorubicin is more than 450mg/m² or epirubicin is more than 900mg/m²
- Uncontrolled electrolyte disorders (eg, hypocalcemia, hypokalemia, hypomagnesemia)
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- Any of the following within 6 months of randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 Grade ≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism
- Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection
- Prior malignancy (including invasive or ductal in-situ breast cancer) within 5 years prior to randomization, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
- Current severe acute or uncontrolled chronic systemic disease (e.g. diabetes mellitus) or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Recent (within the past year) or active suicidal behavior
- Pregnancy or lactation period. Women of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment and for 90 days after discontinuation. A serum pregnancy test must be negative in premenopausal women or women with amenorrhea of less than 12 months
- Major surgery within 2 weeks prior to randomization
- 10 weeks or more have passed since completion of radiotherapy at day of randomization and 16 weeks interval since the date of final surgery have passed
- Prior treatment with any CDK4/6 inhibitor
- Patients treated within the last 7 days prior to randomization and/or concurrent use of drugs known to be strong CYP3A4 inhibitors or inducers
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to randomization
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou
Chang Gong, 86+13925089353, gchang@mail.sysu.edu.cn
- Recruiting
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Weige Tan, 86+2081568636, tanweige@gzhmu.edu.cn
- Recruiting
Shantou Central Hospital
Shantou
Siqi Qiu, 86+075488550450, s_patrick@163.com
- Recruiting
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000
Shengchao Huang, +86 13828223780
About this study
Official title: Ribociclib Plus Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy: an Open-label, Multicenter, Randomized, Phase III Trial
This is a multi-center, open-lable, prospective, randomized phase III clinical trial to investigate the efficacy and safety of adjuvant ribociclib combined with aromatase inhibitor in hormone receptor-positive, HER2-negative early breast cancer with residual disease after neoadjuvant chemotherapy
- Conditions
- Breast Cancer
- Being tested
- Ribociclib plus aromatase inhibitor, Aromatase inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ribociclib plus aromatase inhibitorDrug
Ribociclib (oral 600 mg once daily for 3 weeks on, 1 week off) plus daily aromatase inhibitor (letrozole oral 2·5 mg/day, anastrozole oral 1 mg/day, or exemestane oral 5 mg/day)
Aromatase inhibitorDrug
Daily aromatase inhibitor (letrozole oral 2·5 mg/day, anastrozole oral 1 mg/day, or exemestane oral 5 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib plus aromatase inhibitor | Experimental | Not described Receives: Drug: Ribociclib plus aromatase inhibitor |
| Aromatase inhibitor | Active comparator | Not described Receives: Drug: Aromatase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year invasive disease-free survival
The time from random assignment until the presence of invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence, invasive contralateral breast cancer, second primary invasive cancer (non-breast), or any-cause death assessed by the investigator
Measured: during the 3 years after random assignment
Secondary outcomes (6)
3-year recurrence-free survival
The time from random assignment until the presence of invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence, or any-cause death assessed by the investigator
Measured: during the 3 years after random assignment
3-year distant disease-free survival
The time from random assignment until the presence of distant recurrence, second primary invasive cancer (non-breast), or any-cause death assessed by the investigator
Measured: during the 3 years after random assignment
3-year overall survival
The time from random assignment until any-cause death assessed by the investigator
Measured: during the 3 years after random assignment
Health-related quality of life 1
The score of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30)
Measured: within 7 days before the first treatment and the end of each cycle (each cycle is 28 days)
Health-related quality of life 2
The score of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer-Specific Module (QLQ-BR42)
Measured: within 7 days before the first treatment and the end of each cycle (each cycle is 28 days)
Safety (adverse events)
Safety will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0)
Measured: from signing the informed consent form until 28 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start10 Feb 2026
- Primary completion10 Feb 2030 (estimated)
- Study completion10 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 446 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gong, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400523
- Sponsor's protocol ID
- SYSKY-2026-047
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in future research article after de-identification and the study protocol will be shared beginning 3 months and ending 5 years following publication. Proposals should be directed to gchang@mail.sysu.edu.cn and data will be shared by email.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ribociclib Plus Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy: an Open-label, Multicenter, Randomized, Phase III Trial
- ClinicalTrials.gov ID
- NCT07400523
- Acronym / sponsor ID
- SYSKY-2026-047
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 446 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 10 Feb 2030 (estimated)
- Study completion
- 10 Feb 2031 (estimated)
- First posted
- 10 Feb 2026 (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 is a multi-center, open-lable, prospective, randomized phase III clinical trial to investigate the efficacy and safety of adjuvant ribociclib combined with aromatase inhibitor in hormone receptor-positive, HER2-negative early breast cancer with residual disease after neoadjuvant chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ribociclib plus aromatase inhibitor | Experimental | Drug: Ribociclib plus aromatase inhibitor |
| Aromatase inhibitor | Active comparator | Drug: Aromatase inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Willingness for study participation with written informed consent
- Female with age at least 18 years
- Histologically confirmed unilateral or bilateral primary invasive breast cancer
- Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion
- Histologically confirmed hormone receptor-positive (≥1% ER and/or PR positive stained cells) and HER2-negative (IHC 2+ with FISH-negative or IHC 0-1+) assessed preferably on core biopsy of the breast or tissue from post-neoadjuvant residual invasive disease, or if no other tissue is available the residual tumor of the lymph node can be assessed. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable
Key exclusion criteria (17 listed)
- c/pN+
- Known severe hypersensitivity reactions to compounds similar to ribociclib or to aromatase inhibitor
- Inadequate organ function immediate prior to randomization including: Hemoglobin <10g/dL (100g/L); ANC < 2000/mm³ (< 2.0 x 10^9/L); Platelets <100,000/mm³ (< 100 x 10^9/L); AST or ALT >1.5 x upper limit of normal (ULN); alkaline phosphatase > 2.5 x ULN, total serum bilirubin > 1.25 x ULN; serum creatinine >1.25 x ULN or estimated creatinine clearance < 60 mL/min as calculated using the method standard for the institution; severe and relevant co-morbidity that would interact with the participation in the study
- Evidence for infection including wound infections, Human Immunodeficiency Virus (HIV) or any type of Hepatitis
- The cumulative dose of doxorubicin is more than 450mg/m² or epirubicin is more than 900mg/m²
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 |
|---|---|---|
| Ribociclib plus aromatase inhibitorRibociclib (oral 600 mg once daily for 3 weeks on, 1 week off) plus daily aromatase inhibitor (letrozole oral 2·5 mg/day, anastrozole oral 1 mg/day, or exemestane oral 5 mg/day) | Drug | Ribociclib plus aromatase inhibitor |
| Aromatase inhibitorDaily aromatase inhibitor (letrozole oral 2·5 mg/day, anastrozole oral 1 mg/day, or exemestane oral 5 mg/day) | Drug | Aromatase inhibitor |
Primary outcome
3-year invasive disease-free survival
Time frame: during the 3 years after random assignment
The time from random assignment until the presence of invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence, invasive contralateral breast cancer, second primary invasive cancer (non-breast), or any-cause death assessed by the investigator
6 secondary outcomes
3-year recurrence-free survival
Time frame: during the 3 years after random assignment
3-year distant disease-free survival
Time frame: during the 3 years after random assignment
3-year overall survival
Time frame: during the 3 years after random assignment
Health-related quality of life 1
Time frame: within 7 days before the first treatment and the end of each cycle (each cycle is 28 days)
Health-related quality of life 2
Time frame: within 7 days before the first treatment and the end of each cycle (each cycle is 28 days)
Safety (adverse events)
Time frame: from signing the informed consent form until 28 days after completion of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in future research article after de-identification and the study protocol will be shared beginning 3 months and ending 5 years following publication. Proposals should be directed to gchang@mail.sysu.edu.cn and data will be shared by email.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ribociclib plus aromatase inhibitor and Aromatase inhibitor in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites 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 17 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang Gong, Professor (86+13925089353, gchang@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year invasive disease-free survival (time frame: during the 3 years after random assignment). 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 28 Apr 2026.