HER2 Expression of CTC to Predict Response in HER2-low Advanced Breast Cancer Patients Treated With ADC

An Exploratory Clinical Study of HER2 Expression of Circulating Tumor Cells : Predictive and Prognostic Value in HER2-low Advanced Breast Cancer Patients Treated With ADC

To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-low advanced breast cancer patients treated with ADC

Inclusion Criteria:

• Has pathologically documented breast cancer that:

  1. Is unresectable or metastatic
  2. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
  3. Has progressed on, and would no longer benefit from, endocrine therapy
  4. Has been treated at least 1 prior line of chemotherapy in the metastatic setting

• Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions

• Receives anti-HER2 ADC treatment

• Life expectancy > 3 months

• Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection

• ECOG ≤2

Exclusion Criteria:

• Has breast cancer ever assessed with high-HER2 expression
• Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
• Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
• Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study