Breast CancerPhase 3SENIORNCT07005557
Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer
A Phase 3 study testing Chemotherapy, CDK4/6 Inhibitor and Endocrine therapy in people with Breast Cancer and Adjuvant Therapy, run by Fudan University.
Trial summary
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged >65 years) with lymph… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer, Adjuvant Therapy
- What is being tested?
- Chemotherapy, CDK4/6 Inhibitor and Endocrine therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,244 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 15 May 2035
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- -1. Age: Female patients aged ≥65 years. 2. Disease Status: Histologically confirmed early-stage breast cancer after surgery with ER expression ≥50% AND one of the following:
- ≥4 positive lymph nodes
- 1-3 positive lymph nodes plus at least one of the following high-risk features: i. High-risk multigene assay result ii. Primary tumor size >2 cm iii. Histologic grade 3 iv. Lymphovascular invasion (LVI) positive v. Ki-67 >20% 3. Treatment Acceptance: Willing to receive adjuvant CDK4/6 inhibitor therapy. 4. Performance Status: ECOG score 0-2. 5. Adequate Organ Function:
- Hematology (within 14 days, no transfusion): i. Hemoglobin (Hb) ≥90 g/L ii. Absolute neutrophil count (ANC) ≥1.5×10⁹/L iii. Platelets (PLT) ≥100×10⁹/L b) Biochemistry: i. Total bilirubin (TBIL) ≤1.5×ULN ii. ALT/AST ≤3×ULN iii. Serum creatinine (Cr) ≤1×ULN iv. Estimated creatinine clearance (CrCl) >50 mL/min (Cockcroft-Gault formula) 6. Consent \& Compliance: Willing to participate, sign informed consent, and comply with follow-up.
Who cannot join
- 1. Patients who have received neoadjuvant therapy (including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy).
- 2. Bilateral breast cancer. 3. History of other malignancies, except: Cured basal cell carcinoma of the skin； Carcinoma in situ of the cervix 4. Distant metastasis (any site). 5. Any T4 lesion (UICC 1987 TNM staging), including: Skin invasion; Fixed mass adherence; Inflammatory breast cancer 6. Concurrent participation in other clinical trials. 7. Severe organ dysfunction (cardiac, pulmonary, hepatic, or renal), including:
- LVEF <50% (by echocardiography) b) Major cardiovascular/cerebrovascular events within 6 months before randomization: i. Unstable angina ii. Chronic heart failure iii. Uncontrolled hypertension (>150/90 mmHg) iv. Myocardial infarction or stroke c) Poorly controlled diabetes mellitus d) Severe hypertension 8. Known allergy to taxane-based drugs or their excipients. 9. Severe or uncontrolled infections. 10. History of psychoactive drug abuse (unable to abstain) or psychiatric disorders.
- 11. Patients deemed ineligible by investigator assessment. 12. Refusal to receive adjuvant CDK4/6 inhibitor therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Peng Ji contact
About this study
Official title: Study Evaluating Node-positive, ER+/HER2- In Older (≥65 Years) Breast Cancer Patients for Chemotherapy Exemption: A Randomized, Open-label, Multicenter Phase III Clinical Trial
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged >65 years) with lymph node-positive, HR+/HER2- breast cancer.
- Conditions
- Breast Cancer, Adjuvant Therapy
- Being tested
- Chemotherapy, CDK4/6 Inhibitor, Endocrine therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Chemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.
CDK4/6 InhibitorDrug
All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)
Endocrine therapyDrug
Endocrine therapy (letrozole/anastrozole/exemestane)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Chemotherapy, endocrine therapy, or CDK4/6 inhibitors, administered at the physician's discretion. Receives: Drug: Chemotherapy; Drug: CDK4/6 Inhibitor; Drug: Endocrine therapy |
| Chemo-free | Experimental | A chemotherapy-sparing approach using CDK4/6 inhibitor combined with aromatase inhibitor (minimum 5-year duration). Receives: Drug: CDK4/6 Inhibitor; Drug: Endocrine therapy |
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)
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
Geriatric assessment (G-8)
- Modified Geriatric-8 (G-8) screening tool
Measured: Up to approximately 3 years
Clinical Frailty Scale
Clinical Frailty Scale (CFS, version 2.0)
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 posted5 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 May 2030 (estimated)
- Study completion15 May 2035 (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
- 1,244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhiming Shao, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005557
- Sponsor's protocol ID
- SCHBCC-N089
- Acronym
- SENIOR
- Status last verified
- Jun 2025
- First submitted
- 3 May 2025
- Last updated
- 5 Jun 2025
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Node-positive, ER+/HER2- In Older (≥65 Years) Breast Cancer Patients for Chemotherapy Exemption: A Randomized, Open-label, Multicenter Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT07005557
- Acronym / sponsor ID
- SENIOR / SCHBCC-N089
- Conditions
- Breast Cancer, Adjuvant Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,244 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 May 2030 (estimated)
- Study completion
- 15 May 2035 (estimated)
- First posted
- 5 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. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged >65 years) with lymph node-positive, HR+/HER2- breast cancer.
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: Chemotherapy, Drug: CDK4/6 Inhibitor, Drug: Endocrine therapyChemotherapy, endocrine therapy, or CDK4/6 inhibitors, administered at the physician's discretion. |
| Chemo-free | Experimental | Drug: CDK4/6 Inhibitor, Drug: Endocrine therapyA chemotherapy-sparing approach using CDK4/6 inhibitor combined with aromatase inhibitor (minimum 5-year duration). |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- -1. Age: Female patients aged ≥65 years. 2. Disease Status: Histologically confirmed early-stage breast cancer after surgery with ER expression ≥50% AND one of the following:
- ≥4 positive lymph nodes
- 1-3 positive lymph nodes plus at least one of the following high-risk features: i. High-risk multigene assay result ii. Primary tumor size >2 cm iii. Histologic grade 3 iv. Lymphovascular invasion (LVI) positive v. Ki-67 >20% 3. Treatment Acceptance: Willing to receive adjuvant CDK4/6 inhibitor therapy. 4. Performance Status: ECOG score 0-2. 5. Adequate Organ Function:
- Hematology (within 14 days, no transfusion): i. Hemoglobin (Hb) ≥90 g/L ii. Absolute neutrophil count (ANC) ≥1.5×10⁹/L iii. Platelets (PLT) ≥100×10⁹/L b) Biochemistry: i. Total bilirubin (TBIL) ≤1.5×ULN ii. ALT/AST ≤3×ULN iii. Serum creatinine (Cr) ≤1×ULN iv. Estimated creatinine clearance (CrCl) >50 mL/min (Cockcroft-Gault formula) 6. Consent \& Compliance: Willing to participate, sign informed consent, and comply with follow-up.
Key exclusion criteria (4 listed)
- 1. Patients who have received neoadjuvant therapy (including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy).
- 2. Bilateral breast cancer. 3. History of other malignancies, except: Cured basal cell carcinoma of the skin； Carcinoma in situ of the cervix 4. Distant metastasis (any site). 5. Any T4 lesion (UICC 1987 TNM staging), including: Skin invasion; Fixed mass adherence; Inflammatory breast cancer 6. Concurrent participation in other clinical trials. 7. Severe organ dysfunction (cardiac, pulmonary, hepatic, or renal), including:
- 11. Patients deemed ineligible by investigator assessment. 12. Refusal to receive adjuvant CDK4/6 inhibitor therapy.
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 |
|---|---|---|
| ChemotherapyChemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine. | Drug | Control |
| CDK4/6 InhibitorAll patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib) | Drug | Chemo-free, Control |
| Endocrine therapyEndocrine therapy (letrozole/anastrozole/exemestane) | Drug | Chemo-free, Control |
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
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
Geriatric assessment (G-8)
Time frame: Up to approximately 3 years
Clinical Frailty Scale
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 5 Jun 2025.
- 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.
Peng Ji contact
Zhiming Shao principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chemotherapy, CDK4/6 Inhibitor and Endocrine therapy in people with Breast Cancer and Adjuvant Therapy, run by Fudan University.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 5 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.