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Association details:
| Biomarker: | HER-2 underexpression |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | Aidixi (disitamab vedotin) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
Excerpt:
...Subjects must have HER2 low expression (defined as IHC 1+ or IHC 2+/ISH-) and HR+ status (defined as recent tumor showing ER and/or PR expression ≥1% [according to ASCO/CAP 2020 guidelines]) determined by the central laboratory....
Trial ID:
Source:
Title:
The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression
Excerpt:
...0-1; 5）Patients with low expression of HER-2: HER-2 IHC 1+or HER2 IHC 2+and ISH negative;...
Trial ID:
More C2 evidence
Source:
Title:
Prospective, Single-Arm Phase II Study of Disitamab Vedotin (RC48-ADC) for Early High-Risk or Locally Advanced Estrogen Receptor-Positive/HER2-Low Breast Cancer Treatment
Excerpt:
...Pathologically confirmed HER2 low expression (defined as immunohistochemistry [IHC] 2+, in situ hybridization [ISH]- or IHC 1+); 5. ...
Trial ID:
Less C2 evidence
Source:
Title:
Efficacy and safety of the recombinant humanized anti-HER2 monoclonal antibodyMMAE conjugate RC48-ADC in patients with HER2-positive or HER2-low expressing, metastatic breast cancer: a single-arm phase II study
Published date:
12/02/2023
Excerpt:
The median PFS was 5.7 months (95% CI: 4.6-6.9 months). The DCR was 64.2% (95% CI: 54.9%-72.6%). In the HER2-positive subgroup, the ORR and mPFS were 42.7% (95% CI: 32.0%-54.1%) and 6.3 months (95% CI: 4.9-7.6 months). In the HER2-low expressing subgroup, the ORR and mPFS were 29.0% (95% CI: 16.0%-46.1%) and 3.6 months (95% CI: 2.0-5.3 months)....RC48-ADC showed consistent efficacy in HER2-positive and HER2-low expressing subgroups.
Source:
Title:
397P - Efficacy and safety of the recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate RC48-ADC in patients with HER2-positive or HER2-low expressing, locally advanced or metastatic breast cancer: A single-arm phase II study
Published date:
10/16/2023
Excerpt:
The median PFS was 5.7 months. The DCR was 57.9%. In the HER2-positive subgroup, the ORR and mPFS were 34.5% and 6.3 months. In the HER2-low expressing subgroup, the ORR and mPFS were 22.2% and 3.6 months. In addition, the mPFS in the dual drug combination-treated group was longer than that in the single drug treatment group, with mPFS of 7.1 months and 4.6 months, respectively....RC48-ADC showed consistent efficacy in HER2-positive and HER2-low expressing subgroups.
