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Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer

NCT07616427 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-01

No results posted yet for this study

Summary

This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early breast cancer. All patients initially receive induction treatment with fovinaciclib plus endocrine therapy and HER2-targeted therapy, followed by early assessment of treatment response after 6 weeks of treatment. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to standard neoadjuvant chemotherapy combined with HER2-targeted therapy prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and reduce unnecessary chemotherapy exposure.

Conditions

  • HR+/HER2+ Early Breast Cancer

Interventions

DRUG

Fovinaciclib

CDK4/6 inhibitor

DRUG

Aromatase Inhibitors

Letrozole or anastrozole

DRUG

Trastuzumab + Pertuzumab

dual HER2 blockade

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2028-05-20
Completion
2033-05-20

Countries

  • China

Study Locations

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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 NCT07616427 on ClinicalTrials.gov