CDK4/6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment

Sponsor
Peking University People's Hospital
Study ID
NCT07366112
Phase
PHASE2
Status
Recruiting
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Conditions

  • Early-Stage Breast Cancer
  • HER2-negative Breast Cancer
  • High-risk Breast Cancer
  • Hormone Receptor-Positive Breast Cancer
  • ctDNA Monitoring

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CDK4/6 inhibitor with endocrine therapy — DRUG
    CDK4/6 inhibitor with endocrine therapy for neoadjuvent therapy

Study Details

Exploring the dynamics of ctDNA following neoadjuvant therapy with CDK4/6 inhibitors combined with endocrine treatment, and its potential to guide de-escalation of adjuvant chemotherapy

Key Dates

First listed
Jan 26, 2026
Start date
Apr 20, 2026
Status verified
Feb 2026
Primary completion
Jan 1, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
158 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CDK4/6 inhibitor with endocrine therapy
    Patients receive 4 cycles of neoadjuvant CDK4/6 inhibitor with endocrine therapy. Post-surgery treatment is guided by ctDNA status: ctDNA-negative at baseline and post-neoadjuvant, with post-op Ki67 ≤10% ：Continue CDK4/6 inhibitor with endocrine therapy for 2-3 years. ctDNA-positive → negative, or persistently ctDNA-negative with post-op Ki67 \>10% : Randomized 1:1 to: Arm 1: CDK4/6 inhibitor with endocrine therapy for 2-3 years. Arm 2: Adjuvant chemotherapy (investigator's choice) → CDK4/6 inhibitor with endocrine therapy for 2-3 years. （3）Persistently ctDNA-positive or ctDNA-negative → positive: Adjuvant chemotherapy → CDK4/6 inhibitor with endocrine therapy for 2-3 years. Premenopausal women receive ovarian suppression with LHRH agonists.

Primary Outcome Measure

ctDNA Clearance Rate after Neoadjuvant Therapy [ Time Frame: From baseline to 4 weeks post-neoadjuvant therapy (pre-surgery) ]

Central Contacts

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