Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer
Recruiting now · Phase 2
Conditions studied: HR+/HER2+ Early Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07616427
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 100
- Starts
- 2026-05-20
- Expected to finish
- 2033-05-20
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
Where it is running
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
- 2nd Affiliated Hospital, School of Medicine — Hangzhou, Zhejiang, China (enrolling)
- Ningbo No. 2 Hospital — Ningbo, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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