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Study identifier: NCT07616427 Synced from ClinicalTrials.gov · July 29, 2026
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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

Condition: HR+/HER2+ Early Breast Cancer  ·  Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

PhasePhase 2
Planned participants100
Who can joinFemale, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Yunxiang Zhou  ·  15868131018  ·  yxzhou@zju.edu.cn

Always discuss trial participation with your own doctor first.

Locations (3)

The First Affiliated Hospital of Nanjing Medical UniversityNanjing, Jiangsu, ChinaRecruiting
2nd Affiliated Hospital, School of MedicineHangzhou, Zhejiang, ChinaRecruiting
Ningbo No. 2 HospitalNingbo, Zhejiang, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07616427