Clinical trial · Interventional
Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy | Drug | — | UNRESOLVED |
| aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm #1: Endocrine+CDK4/6i
- description
- aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor without chemotherapy
- interventionNames
- Drug: aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
- type
- ACTIVE_COMPARATOR
- label
- Arm #2: TC*4-Endocrine+CDK4/6i
- description
- 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
- interventionNames
- Drug: 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
- Drug: aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:
* 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;
* 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.
Exclusion Criteria:
* 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;
* 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.References
Publications (0)
Data not yet available