CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Breast Cancer

NCT07213206 | Not Yet Recruiting Phase 3

• 1 other identifier: SCHBCC-N095
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators designed a phase III clinical trial involving hormone receptor-positive and HER2-positive stage I breast cancer patients. This trial aims to evaluate the efficacy and safety of a treatment regimen combining CDK4/6 inhibitors, endocrine therapy, and anti-HER2 therapy compared with the traditional approach of chemotherapy combined with anti-HER2 therapy.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• iDFS

  invasive disease-free survival

  3 years

Secondary Outcomes (4)

• RFS

  3 years

• DRFS

  3 years

• OS

  3 years

• adverse effects

  3 years

Study Arms (2)

CDK 4/6 inhibitor combined therapy (omit chemo)

EXPERIMENTAL

CDK4/6 inhibitor for two years combined with endocrine therapy for five years and Trastuzumab(without chemo) for one year

Drug: CDK 4/6 inhibitor combined therapy (omit chemo)

standard of care

ACTIVE COMPARATOR

four cycles of docetaxel and cyclophosphamide or four cycles of weekly paclitaxel combined with Trastuzumab for one year

Drug: standard of care

Interventions

CDK 4/6 inhibitor combined therapy (omit chemo) DRUG

CDK 4/6 inhibitor and endocrine therapy combined with Trastuzumab ( without chemotherapy)

CDK 4/6 inhibitor combined therapy (omit chemo)

standard of care DRUG

four cycles of docetaxel and cyclophosphamide or four cycles of weekly paclitaxel Combined with Trastuzumab followed by standard endocrine therapy( aromatase inhibitors or tamoxifen，Ovarian function suppression agents may be added if premenopausal)

standard of care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged between 18 and 75 years;
• Unilateral invasive carcinoma confirmed by histopathological examination;
• Postoperative pathological stage I early breast cancer: histologically confirmed invasive carcinoma with a maximum tumor diameter not exceeding 2 cm and no lymph node metastasis (N0);
• Estrogen receptor (ER) expression ≥ 50%;
• Immunohistochemical and molecular pathology must meet one of the following criteria: HER-2 overexpression (3+) or HER-2 (0-2+) with gene amplification confirmed by fluorescence in situ hybridization (FISH);
• Histological grade 1-2 or selected grade 3 tumors with at least one of the following additional features: PAM50 or HER2-based subtyping indicating luminal phenotype , or tumor size ≤ 1 cm );
• Adequate major organ function, defined as:
• (1) Hematologic parameters: hemoglobin (HB) ≥ 90 g/L (without blood transfusion within 14 days), absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 100 × 10⁹/L; (2) Biochemical parameters: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, serum creatinine (Cr) ≤ 1 × ULN, and calculated creatinine clearance \> 50 mL/min using the Cockcroft-Gault formula; 8) Cardiac function preserved with left ventricular ejection fraction (LVEF) \> 50%; 9) Willing to participate in the study, with signed informed consent, good compliance, and willingness to comply with follow-up requirements.

You may not qualify if:

• Tumors with a maximum diameter exceeding 2 cm and/or presence of positive axillary lymph nodes;
• HER2-negative status defined as HER2- or HER2+ by immunohistochemistry; or HER2 2+ by immunohistochemistry without gene amplification confirmed by fluorescence in situ hybridization (FISH);
• Patients who have previously received neoadjuvant therapy or any form of systemic or non-surgical local treatment prior to enrollment, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy;
• History of other malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;
• Has metastatic (Stage 4) breast cancer;
• Pregnant or lactating women, as well as women of childbearing potential who are unable to use effective contraception;
• Patients currently enrolled in other clinical trials;
• Severe organ dysfunction involving the cardiovascular, pulmonary, hepatic, or renal systems, including left ventricular ejection fraction (LVEF) \< 50% as assessed by echocardiography; history of severe cardiovascular or cerebrovascular events within 6 months prior to enrollment (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \> 150/90 mmHg, myocardial infarction, or stroke); patients with poorly controlled diabetes mellitus; patients with severe or uncontrolled hypertension;
• Active severe or uncontrolled infections;
• Patients with a history of substance abuse involving psychotropic drugs with ongoing dependency, or a documented history of psychiatric disorders that may interfere with study compliance;
• Patients deemed unsuitable for participation by the principal investigator or designated study physician.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Zhimin C Shao

CONTACT

02164175590; zhimingshao@yahoo.com

Yin Liu

CONTACT

02164175590; liuyinfudan@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: October 8, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2035
• Last Updated: October 8, 2025

Record last verified: 2025-10