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

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 chemother

Trial Details

NCT ID
NCT07616427
Phase
PHASE2
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Fovinaciclib
  • Aromatase Inhibitors
  • Trastuzumab + Pertuzumab
Locations (sample)
  • Nanjing, Jiangsu, China|32.06167,118.77778
  • Hangzhou, Zhejiang, China|30.29365,120.16142
  • Ningbo, Zhejiang, China|29.87819,121.54945

Key Eligibility Criteria

  • Female patients aged ≥18 years and ≤75 years. Histologically confirmed HR-positive (ER \>10%) and HER2-positive (IHC 3+ or IHC 2+/ISH+) early-stage…
  • Pathologically staged as stage I-III according to the American Joint Committee on Cancer (AJCC) 8th edition staging system.
  • Premenopausal patients must receive ovarian function suppression. Considered suitable for aromatase inhibitor treatment according to investigator a…
  • Presence of evaluable disease according to RECIST version 1.1, including measurable and/or non-measurable lesions.

For full eligibility, visit ClinicalTrials.gov.

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