Breast CancerPhase 3NCT07019363
CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)
A Phase 3 study testing Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) and Standard endocrine therapy combined with CDK4/6 Inhibitor in people with Breast Cancer and Adjuvant Therapy, run by Fudan University at 1 site in China.
Trial summary
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Adjuvant Therapy
- What is being tested?
- Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) and Standard endocrine therapy combined with CDK4/6 Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,903 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2025to 15 Apr 2033
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged ≥18 and ≤70 years.
- ECOG systemic status grade 0 to 1.
- Histologically confirmed invasive HR+/HER2+ breast cancer (Specific definition: breast cancer patients whose estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2) are all determined to be positive by pathologic testing. Specifically: ER positive: IHC>10%, PR positive: IHC>10%, HER2 positive: IHC+++ or IHC++ but amplified by FISH.
- Early-stage breast cancer after radical mastectomy with postoperative pathology consistent with TNM staging of ≥pN1 ; or postoperative pathology suggestive of non-pCR after neoadjuvant therapy; or postoperative pathology suggestive of pCR after neoadjuvant therapy but with clinical staging consistent with cT4 or N3 before neoadjuvant therapy
- Within 1 year of completion of adjuvant anti-HER2 targeted therapy: anti-HER2 targeted therapy includes trastuzumab-based therapy, and/or T-DM1 therapy, and/or TKI therapy.
- The function of major organs is basically normal, and the following conditions are met: ① The criteria for routine blood tests need to be met: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 75 × 109/L; ② The biochemical tests need to be met as follows: TBIL ≤ 1.5 × ULN (the upper limit of normal value); ALT and AST ≤ 3 × ULN; serum Cr ≤ 1 × ULN, and endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula).
- Female subjects of childbearing potential are required to use a medically approved form of contraception during study treatment, and for at least 3 months after the last dose of study drug.
- Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant, and cooperated with follow-up visits.
Who cannot join
- Bilateral breast cancer;
- Metastasis to any site;
- Taking food or medications that are strong inhibitors or inducers of CYP3/4.
- Strong inhibitors of CYP3/4 include: boceprevir, clarithromycin, konifactam, delavirdine, indinavir, itraconazole, ketoconazole, ritonavir, mibefradil, miconazole, fazodone, nelfinavir, propoxiconazole, ritonavir, saquinavir, naloxone, telaprevir, telithromycin, voriconazole, grapefruit, grapefruit juice, or grapefruit containing foods.
- Strong inducers of CYP3/4 including carbamazepine, phenytoin, pramipexole, rifampin, and St. John's wort.
- History of clinically significant or uncontrolled cardiac disease including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
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- other malignancy within the previous 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
- Pregnant or lactating women, women of childbearing age who are unable to use effective contraception;
- Patients who are concurrently enrolled in other clinical trials;
- severe or uncontrolled infection;
- Patients with known active HBV or HCV infection or Hepatitis B DNA ≥500, or chronic stage with abnormal liver function;
- Those with a history of psychotropic substance abuse that cannot be stopped or those with psychiatric disorders;
- Patients who, in the judgment of the investigator, are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
min he contact
About this study
Official title: A Study on the Efficacy and Safety of CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients Who Have Completed Adjuvant Anti-HER2 Targeted Therapy"
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine therapy in HR+/HER2+ early breast cancer patients.
- Conditions
- Breast Cancer, Adjuvant Therapy
- Being tested
- Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane), Standard endocrine therapy combined with CDK4/6 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.
Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)Drug
Standard endocrine therapy
Standard endocrine therapy combined with CDK4/6 InhibitorDrug
CDK4/6 inhibitor therapy for 2 years in combination with standard endocrine therapy
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | endocrine therapy Receives: Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) |
| Experimental | Experimental | Standard endocrine therapy combined with CDK4/6i Receives: Drug: Standard endocrine therapy combined with CDK4/6 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-years Invasive disease free survival
5-year invasive disease-free survival (iDFS), defined as the time from randomization to the first occurrence of: local recurrence, distant metastasis, contralateral invasive breast cancer, death from any cause.
Measured: 5 years
Secondary outcomes (4)
Distant Recurrence-Free Survival (DRFS)
DRFS is defined as the time interval from the start of cancer treatment to the first occurrence of distant metastasis or death from any cause.
Measured: 5 years
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: Approximately 5 years
Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).
Incidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc.
Measured: Up to approximately 3 years
Patient-Reported Outcome (PRO)
Patient-Reported Outcome (PRO) refers to a report that comes directly from the patient on her health status, functional status, and experience of treatment, without interpretation by healthcare or other personnel (e.g., symptoms, quality of life, physical functioning, etc.), and is usually collected through standardized questionnaires or scales. Lower scores in European Organization for Research and Treatment of Cancer(EORTC) QLQ-BR45 questionnaire will mean a better outcome.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start15 Jun 2025
- Primary completion15 May 2029 (estimated)
- Study completion15 Apr 2033 (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 Fudan 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
- 1,903 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- zhimin shao, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019363
- Sponsor's protocol ID
- SCHBCC-N091
- Status last verified
- Jun 2025
- First submitted
- 4 May 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients Who Have Completed Adjuvant Anti-HER2 Targeted Therapy"
- ClinicalTrials.gov ID
- NCT07019363
- Acronym / sponsor ID
- SCHBCC-N091
- Conditions
- Breast Cancer, Adjuvant Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,903 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 May 2029 (estimated)
- Study completion
- 15 Apr 2033 (estimated)
- First posted
- 13 Jun 2025 (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 study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine therapy in HR+/HER2+ early breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)endocrine therapy |
| Experimental | Experimental | Drug: Standard endocrine therapy combined with CDK4/6 InhibitorStandard endocrine therapy combined with CDK4/6i |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females aged ≥18 and ≤70 years.
- ECOG systemic status grade 0 to 1.
- Histologically confirmed invasive HR+/HER2+ breast cancer (Specific definition: breast cancer patients whose estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2) are all determined to be positive by pathologic testing. Specifically: ER positive: IHC>10%, PR positive: IHC>10%, HER2 positive: IHC+++ or IHC++ but amplified by FISH.
- Early-stage breast cancer after radical mastectomy with postoperative pathology consistent with TNM staging of ≥pN1 ; or postoperative pathology suggestive of non-pCR after neoadjuvant therapy; or postoperative pathology suggestive of pCR after neoadjuvant therapy but with clinical staging consistent with cT4 or N3 before neoadjuvant therapy
- Within 1 year of completion of adjuvant anti-HER2 targeted therapy: anti-HER2 targeted therapy includes trastuzumab-based therapy, and/or T-DM1 therapy, and/or TKI therapy.
Key exclusion criteria (13 listed)
- Bilateral breast cancer;
- Metastasis to any site;
- Taking food or medications that are strong inhibitors or inducers of CYP3/4.
- History of clinically significant or uncontrolled cardiac disease including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
- other malignancy within the previous 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
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 |
|---|---|---|
| Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)Standard endocrine therapy | Drug | Control |
| Standard endocrine therapy combined with CDK4/6 InhibitorCDK4/6 inhibitor therapy for 2 years in combination with standard endocrine therapy | Drug | Experimental |
Primary outcome
5-years Invasive disease free survival
Time frame: 5 years
5-year invasive disease-free survival (iDFS), defined as the time from randomization to the first occurrence of: local recurrence, distant metastasis, contralateral invasive breast cancer, death from any cause.
4 secondary outcomes
Distant Recurrence-Free Survival (DRFS)
Time frame: 5 years
Overall Survival (OS)
Time frame: Approximately 5 years
Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).
Time frame: Up to approximately 3 years
Patient-Reported Outcome (PRO)
Time frame: Up to approximately 3 years
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 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
min he contact
zhimin shao principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) and Standard endocrine therapy combined with CDK4/6 Inhibitor in people with Breast Cancer and Adjuvant Therapy, run by Fudan 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 8 inclusion and 13 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 21 Jan 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 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 Zhimin Shao, MD, PhD (+86-021-64175590, zhi_ming_shao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-years Invasive disease free survival (time frame: 5 years). 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 21 Jan 2026.