Breast CancerPhase 3NCT06996093
Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor
A Phase 3 study testing 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy and aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy and aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,508 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2025to 1 Jun 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females and males aged 18-70 years;
- ECOG performance status 0-1;
- Early-stage breast cancer, with postoperative pathology confirming invasive carcinoma, HR-positive and HER2-negative (In this study, HR-positive is defined as: ER-positive by IHC with >10% tumor cells staining positive; HER2-negative defined as HER2 0-1+ by IHC or HER2++ with negative FISH result, without amplification);
- Postoperative pathological stage pT2N0M0 and:
- Histological grade 3, or Histological grade 2 with Ki67 ≥ 20% or high-risk multigene assay results;
- No prior neoadjuvant therapy received;
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- Good postoperative recovery, with randomization occurring no more than 8 weeks after surgery;
- Normal function of major organs, meeting the following criteria:
- Hematological tests must meet: HB ≥90 g/L (no transfusion within 14 days); ANC ≥1.5×10⁹/L; PLT ≥100×10⁹/L; Biochemical tests must meet: TBIL ≤1.5×ULN (upper limit of normal); ALT and AST ≤3×ULN; serum Cr ≤1.5×ULN;
- Contraception required for male participants and women of childbearing potential during treatment;
- Participants voluntarily enroll in the study, sign informed consent, demonstrate good compliance, and cooperate with follow-up.
Who cannot join
- Bilateral breast cancer or carcinoma in situ (DCIS/LCIS);
- Metastasis at any site;
- Clinical or imaging suspicion of malignancy in the contralateral breast requiring biopsy (unless ruled out);
- Prior neoadjuvant therapy, including chemotherapy, radiotherapy, or endocrine therapy;
- Use of tamoxifen, raloxifene, or aromatase inhibitors (AIs) for breast cancer risk reduction ("chemoprevention") and/or osteoporosis treatment within the past 2 years;
- History of other malignancies within the past 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix), including contralateral breast cancer;
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- Concurrent participation in another clinical trial;
- Severe systemic diseases and/or uncontrolled infections that preclude study participation;
- Severe cardiovascular or cerebrovascular events within 6 months before randomization (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >150/90 mmHg, myocardial infarction, or stroke);
- Known hypersensitivity to the study drugs;
- Men and women of childbearing potential unwilling to use contraception during treatment and for 8 weeks after treatment completion;
- Pregnant or lactating women;
- Positive pregnancy test before study drug administration (for women of childbearing potential);
- Psychiatric disorders, cognitive impairment, or inability to comprehend the trial protocol, adverse effects, or comply with study procedures and follow-up (requires systematic evaluation before enrollment);
- Individuals lacking personal freedom or legal capacity for independent civil conduct.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, MD, PhD, +86-021-64175590 ext. 8808, zhimingshao@yahoo.com
Wenjia Zuo, MD, +86-18017312648, wenjiaz07@126.com
About this study
Official title: Chemotherapy Omission in Hormone Receptor(HR)-Positive/Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
Read the detailed description
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
In this study, patient eligible will be randomized into either standard endocrine therapy plus CDK4/6 inhibitor without chemotherapy or standard endocrine therapy plus CDK4/6 inhibitor following 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy.The safety and efficacy of each group will be assessed through invasive disease free survival (iDFS), disease-free survival (DFS), distant disease free survival (DDFS), overall survival (OS) and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and patient reported outcome (PRO).
- Conditions
- Breast Cancer
- Being tested
- 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
- Keywords
- adjuvant chemotherapy omission, adjuvant ribociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapyDrug
4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitorDrug
aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Arm #1: Endocrine+CDK4/6i | Experimental | aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor without chemotherapy Receives: Drug: aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor |
| Arm #2: TC*4-Endocrine+CDK4/6i | Active comparator | 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor Receives: Drug: 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy; Drug: aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
invasive disease free survival
Invasive disease-free survival (IDFS), defined as occurrence of any of the following: ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or second non-breast invasive cancer.
Measured: 4 years
Secondary outcomes (4)
distant disease free survival
Distant disease free survival refers to the proportion of people alive and without distant metastases at a specified period after diagnosis, even if they had a local recurrence
Measured: 4 years
overall survival
Overall survival (OS), defined as the time from the start of the study to the occurrence of death.
Measured: 4 years
adverse effects
adverse effects graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0
Measured: 4 years
patient reported outcome
Information about a patient's health that comes directly from the patient. Examples of patient-reported outcomes include a patient's description of their symptoms, their satisfaction with care, and how a disease or treatment affects their physical, mental, emotional, spiritual, and social well-being. Lower scores in European Organization for Research and Treatment of Cancer(EORTC) QLQ-BR45 questionnaire will mean a better outcome.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start2 Jun 2025 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 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
- Model description
- Arm #1: standard endocrine therapy plus CDK4/6 inhibitor without chemotherapy Arm #2: 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by standard endocrine therapy plus CDK4/6 inhibitor
- Masking
- None (open label)
- Enrolment
- 2,508 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, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996093
- Sponsor's protocol ID
- SCHBCC-N087
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Omission in Hormone Receptor(HR)-Positive/Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor
- ClinicalTrials.gov ID
- NCT06996093
- Acronym / sponsor ID
- SCHBCC-N087
- Conditions
- Breast Cancer
- Keywords
- adjuvant chemotherapy omission, adjuvant ribociclib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,508 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2034 (estimated)
- First posted
- 30 May 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 is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
Detailed description
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
In this study, patient eligible will be randomized into either standard endocrine therapy plus CDK4/6 inhibitor without chemotherapy or standard endocrine therapy plus CDK4/6 inhibitor following 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy.The safety and efficacy of each group will be assessed through invasive disease free survival (iDFS), disease-free survival (DFS), distant disease free survival (DDFS), overall survival (OS) and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and patient reported outcome (PRO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm #1: standard endocrine therapy plus CDK4/6 inhibitor without chemotherapy Arm #2: 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by standard endocrine therapy plus CDK4/6 inhibitor
| Arm | Type | Receives |
|---|---|---|
| Arm #1: Endocrine+CDK4/6i | Experimental | Drug: aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitoraromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor without chemotherapy |
| Arm #2: TC*4-Endocrine+CDK4/6i | Active comparator | Drug: 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, Drug: aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Females and males aged 18-70 years;
- ECOG performance status 0-1;
- Early-stage breast cancer, with postoperative pathology confirming invasive carcinoma, HR-positive and HER2-negative (In this study, HR-positive is defined as: ER-positive by IHC with >10% tumor cells staining positive; HER2-negative defined as HER2 0-1+ by IHC or HER2++ with negative FISH result, without amplification);
- Postoperative pathological stage pT2N0M0 and:
- Histological grade 3, or Histological grade 2 with Ki67 ≥ 20% or high-risk multigene assay results;
Key exclusion criteria (15 listed)
- Bilateral breast cancer or carcinoma in situ (DCIS/LCIS);
- Metastasis at any site;
- Clinical or imaging suspicion of malignancy in the contralateral breast requiring biopsy (unless ruled out);
- Prior neoadjuvant therapy, including chemotherapy, radiotherapy, or endocrine therapy;
- Use of tamoxifen, raloxifene, or aromatase inhibitors (AIs) for breast cancer risk reduction ("chemoprevention") and/or osteoporosis treatment within the past 2 years;
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 |
|---|---|---|
| 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy | Drug | Arm #2: TC*4-Endocrine+CDK4/6i |
| aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitoraromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor | Drug | Arm #1: Endocrine+CDK4/6i, Arm #2: TC*4-Endocrine+CDK4/6i |
Primary outcome
invasive disease free survival
Time frame: 4 years
Invasive disease-free survival (IDFS), defined as occurrence of any of the following: ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or second non-breast invasive cancer.
4 secondary outcomes
distant disease free survival
Time frame: 4 years
overall survival
Time frame: 4 years
adverse effects
Time frame: 4 years
patient reported outcome
Time frame: 4 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 30 May 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.
Zhimin Shao, MD, PhD 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 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy and aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor 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 11 inclusion and 15 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 30 May 2025. 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 ext. 8808, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
invasive disease free survival (time frame: 4 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 30 May 2025.