A Prospective Phase Ib Study of Anlotinib With Trastuzumab Deruxtecan for HER2-Low Unresectable and/or Metastatic Breast Cancer (ALTER-BC-Ib-01)
This study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy.
• 1\. Age 18 - 75 years; ECOG PS 0 or 1. 2. Pathologically documented breast cancer that:
‣ Is unresectable or metastatic.
⁃ Has a history of low HER2 expression (IHC 1+\& IHC 2+/ISH- or 0\<IHC\<1+).
⁃ Is HR-positive or HR-negative.
⁃ Has progressed on, and would no longer benefit from, endocrine therapy.
⁃ Has been treated with ≥1 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting.
‣ 3\. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1（Previously treated lesions with radiotherapy or focal therapy and no progression cannot be included as target lesion for assessment）.
‣ 4\. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
‣ 5\. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 6 months.