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CDK4/6 Inhibitors Intensification for Chemotherapy Omission in Small Size High-risk ER-positive Breast Cancer（Cinnamon）

NCT07432178 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2288

Last updated 2026-04-02

No results posted yet for this study

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.). 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

Interventions

DRUG

Dalpiciclib+AI ± OFS

Chemotherapy-free regimen Dalpiciclib 125mg qd d1-d21 Q4W orally for 2 years Combined with AI (at least 5 years) ± OFS

DRUG

TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy

TC (Docetaxel + Cyclophosphamide) × 4 cycles Endocrine therapy according to current indications and physician's choice

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2031-03-31
Completion
2034-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07432178 on ClinicalTrials.gov