Breast CancerPhase 3NCT07432178
CDK4/6 Inhibitors Intensification for Chemotherapy Omission in Small Size High-risk ER-positive Breast Cancer（Cinnamon）
A Phase 3 study testing Dalpiciclib+AI ± OFS and TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is a Phase III non-inferiority trial targeting a specific subset of early breast cancer patients: those with HR-positive/HER2-negative, node-negative small tumors (typically ≤2cm) but who exhibit high-risk features for recurrence (such as high histological grade, high Ki-67 index, etc.). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dalpiciclib+AI ± OFS and TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,288 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2026to 31 Mar 2034
- 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
- Female, aged 18 to 70 years.
- Histologically confirmed early breast cancer with pathological stage T1N0, 0.5 cm < tumor size ≤ 2 cm, ER-positive/HER2-negative, with ER expression ≥ 50%; and willingness to receive adjuvant dalpiciclib treatment.
- Presence of at least one of the following high-risk features:
- Ki-67 index ≥ 50%; Grade 3 (G3) tumor; an indication for chemotherapy based on results from multigene assays, including the 21-gene recurrence score and the 70-gene signature ; Age ≤ 40 years.
- ECOG performance status: 0 to 1.
- Adequate organ function, defined as meeting the following criteria:
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- Hematology (no blood transfusion within 14 days): Hemoglobin (HB) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet (PLT) ≥ 100 × 10⁹/L.
- Biochemistry: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN; Serum Creatinine (Cr) ≤ 1 × ULN, with creatinine clearance > 50 mL/min (calculated using the Cockcroft-Gault formula).
- Voluntary participation with written informed consent, good compliance, and willingness to comply with follow-up requirements.
Who cannot join
- Patients who have received neoadjuvant therapy, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy.
- Bilateral breast cancer.
- History of other prior malignancies, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- 4) Evidence of metastasis at any site. 5) Any T4 lesion (UICC 1987), including skin involvement, tumor fixation/mass, or inflammatory breast cancer.
- 6) Pregnant or lactating women, or women of childbearing potential who are unwilling to use adequate contraception.
- 7) Concurrent participation in another clinical trial. 8) Severe organ dysfunction (cardiac, pulmonary, hepatic, or renal). Left Ventricular Ejection Fraction (LVEF) < 50% (by echocardiography). History of severe cardiovascular or cerebrovascular disease within 6 months prior to randomization (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >150/90 mmHg, myocardial infarction, or cerebrovascular accident). Patients with poorly controlled diabetes mellitus or severe hypertension.
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- 9) Known hypersensitivity to taxanes or their excipients. 10)Severe or uncontrolled infection. 11)History of psychoactive substance abuse that cannot be discontinued, or history of mental disorders.
- 12)Patients deemed by the investigator to be unsuitable for participation in this study.
- 13)Patient refusal to receive adjuvant dalpiciclib treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Zhimin Shao, 02164175590, zhimingshao@yahoo.com
About this study
This study is a Phase III non-inferiority trial targeting a specific subset of early breast cancer patients: those with HR-positive/HER2-negative, node-negative small tumors (typically ≤2cm) but who exhibit high-risk features for recurrence (such as high histological grade, high Ki-67 index, etc.). Currently, the standard adjuvant treatment for these patients often includes chemotherapy followed by endocrine therapy, despite their small tumor size, due to the high-risk biological characteristics. However, chemotherapy can bring significant toxicity and long-term side effects.
This trial explores whether a chemotherapy-sparing approach is feasible. It compares the efficacy and safety of using the CDK4/6 inhibitor Dalpiciclib combined with endocrine therapy (AI ± OFS) directly, without chemotherapy, against the traditional approach of chemotherapy (TC regimen) followed by endocrine therapy. The primary goal is to demonstrate that the chemotherapy-free regimen is not inferior to the chemotherapy-containing regimen in terms of 5-year invasive disease-free survival (iDFS). If successful, this study could potentially de-escalate treatment for this high-risk population, sparing them from chemotherapy-related toxicities while maintaining excellent oncological outcomes.
- Conditions
- Breast Cancer
- Being tested
- Dalpiciclib+AI ± OFS, TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy
- Keywords
- Luminal breast cancer, non-inferiority trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalpiciclib+AI ± OFSDrug
Chemotherapy-free regimen Dalpiciclib 125mg qd d1-d21 Q4W orally for 2 years Combined with AI (at least 5 years) ± OFS
TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapyDrug
TC (Docetaxel + Cyclophosphamide) × 4 cycles Endocrine therapy according to current indications and physician's choice
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy-free arm | Experimental | Not described Receives: Drug: Dalpiciclib+AI ± OFS |
| standard-of-care | Active comparator | Not described Receives: Drug: TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
iDFS
It is defined as the percentage of patients who remain free of invasive disease recurrence, secondary primary invasive cancers, or death from any cause over a 5-year period from randomization or initiation of study treatment.
Measured: 5 years
Secondary outcomes (6)
DFS
It measures the proportion of patients who remain free of detectable disease (including recurrence, progression, or new primary cancer) and alive for 5 years after starting treatment or randomization.
Measured: 5 years
DDFS
5-year DDFS is an oncology clinical trial endpoint that specifically measures the proportion of patients who remain free of distant metastasis (spread of cancer to remote organs) and death from the cancer within 5 years after initiation of study treatment or randomization. It focuses exclusively on distant metastatic events rather than all disease recurrences.
Measured: 5 years
RFS
5-year RFS is an oncology clinical trial endpoint that measures the proportion of patients who remain free of disease recurrence (local, regional, or distant) for 5 years following curative-intent treatment (typically surgery). It specifically focuses on recurrence of the original primary cancer and does not include new primary cancers unrelated to the initial diagnosis.
Measured: 5 years
OS
Overall Survival (OS) is the gold standard efficacy endpoint in oncology clinical trials, defined as the time from randomization (or treatment initiation) to death from any cause. It represents the most objective and clinically meaningful measure of treatment benefit, directly reflecting whether a therapy prolongs patients' lives.
Measured: 5 years
Safety and Tolerability
Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 5.0) Toxicity Reporting Criteria.
Measured: 5 years
Quality of Life score in the per-protocol population
The quality of life of patients was assessed using the EORTC QLQ-C30 questionnaire before, during, and after treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start3 Apr 2026
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2034 (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
- 2,288 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 U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432178
- Sponsor's protocol ID
- SCHBCC-N0107
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CDK4/6 Inhibitors Intensification for Chemotherapy Omission in Small Size High-risk ER-positive Breast Cancer（Cinnamon）
- ClinicalTrials.gov ID
- NCT07432178
- Acronym / sponsor ID
- SCHBCC-N0107
- Conditions
- Breast Cancer
- Keywords
- Luminal breast cancer, non-inferiority trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,288 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2034 (estimated)
- First posted
- 25 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 study is a Phase III non-inferiority trial targeting a specific subset of early breast cancer patients: those with HR-positive/HER2-negative, node-negative small tumors (typically ≤2cm) but who exhibit high-risk features for recurrence (such as high histological grade, high Ki-67 index, etc.). Currently, the standard adjuvant treatment for these patients often includes chemotherapy followed by endocrine therapy, despite their small tumor size, due to the high-risk biological characteristics. However, chemotherapy can bring significant toxicity and long-term side effects.
This trial explores whether a chemotherapy-sparing approach is feasible. It compares the efficacy and safety of using the CDK4/6 inhibitor Dalpiciclib combined with endocrine therapy (AI ± OFS) directly, without chemotherapy, against the traditional approach of chemotherapy (TC regimen) followed by endocrine therapy. The primary goal is to demonstrate that the chemotherapy-free regimen is not inferior to the chemotherapy-containing regimen in terms of 5-year invasive disease-free survival (iDFS). If successful, this study could potentially de-escalate treatment for this high-risk population, sparing them from chemotherapy-related toxicities while maintaining excellent oncological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy-free arm | Experimental | Drug: Dalpiciclib+AI ± OFS |
| standard-of-care | Active comparator | Drug: TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female, aged 18 to 70 years.
- Histologically confirmed early breast cancer with pathological stage T1N0, 0.5 cm < tumor size ≤ 2 cm, ER-positive/HER2-negative, with ER expression ≥ 50%; and willingness to receive adjuvant dalpiciclib treatment.
- Presence of at least one of the following high-risk features:
- Ki-67 index ≥ 50%; Grade 3 (G3) tumor; an indication for chemotherapy based on results from multigene assays, including the 21-gene recurrence score and the 70-gene signature ; Age ≤ 40 years.
- ECOG performance status: 0 to 1.
Key exclusion criteria (9 listed)
- Patients who have received neoadjuvant therapy, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy.
- Bilateral breast cancer.
- History of other prior malignancies, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- 4) Evidence of metastasis at any site. 5) Any T4 lesion (UICC 1987), including skin involvement, tumor fixation/mass, or inflammatory breast cancer.
- 6) Pregnant or lactating women, or women of childbearing potential who are unwilling to use adequate contraception.
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 |
|---|---|---|
| Dalpiciclib+AI ± OFSChemotherapy-free regimen Dalpiciclib 125mg qd d1-d21 Q4W orally for 2 years Combined with AI (at least 5 years) ± OFS | Drug | Chemotherapy-free arm |
| TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapyTC (Docetaxel + Cyclophosphamide) × 4 cycles Endocrine therapy according to current indications and physician's choice | Drug | standard-of-care |
Primary outcome
iDFS
Time frame: 5 years
It is defined as the percentage of patients who remain free of invasive disease recurrence, secondary primary invasive cancers, or death from any cause over a 5-year period from randomization or initiation of study treatment.
6 secondary outcomes
DFS
Time frame: 5 years
DDFS
Time frame: 5 years
RFS
Time frame: 5 years
OS
Time frame: 5 years
Safety and Tolerability
Time frame: 5 years
Quality of Life score in the per-protocol population
Time frame: 5 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 28 Sep 2026.
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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.
Zhimin Shao principal investigator
Fudan U
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 Dalpiciclib+AI ± OFS and TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy in people with Breast Cancer, 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 9 inclusion and 9 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 Sep 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 Professor (08664175590 Ext. Ext. 88807, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iDFS (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 28 Sep 2026.