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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | zanidatamab (ZW25) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer
Excerpt:
...All patients in both Parts 1 and 2 must have HER2-positive and HR-positive disease....
Trial ID:
Source:
Title:
Neoadjuvant zanidatamab for stage I node negative HER2 positive breast cancer
Published date:
12/02/2023
Excerpt:
Four (36%) had pCR, 3 RCB1 (28%) and 4 RCB2 (36%)….Neoadjuvant zanidatamab demonstrates significant preliminary efficacy, (pCR/RCB-1 64%) with a good safety profile in patients with stage I node negative HER2+ BC.
Source:
Title:
Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy (1L) for patients (pts) with advanced HER2-positive breast cancer (BC): Updated results from a phase 1b/2 study.
Published date:
05/25/2023
Excerpt:
Of the 33 efficacy evaluable (EE) pts, confirmed ORR was 90.9% (95% confidence interval [CI]: 75.7, 98.1)….Zani combined with docetaxel demonstrated promising antitumor activity as 1L therapy for advanced HER2+ BC, with a manageable safety profile.
DOI:
10.1200/JCO.2023.41.16_suppl.1044
Trial ID:
Source:
Title:
132P - Neoadjuvant zanidatamab for stage I node negative HER2 positive breast cancer (BC) (ID 345)
Published date:
05/07/2023
Excerpt:
Neoadjuvant zanidatamab for 3 months showed significant efficacy, (pCR/RCB-1 64%) w/ acceptable safety profile in pts w/ stage I node neg HER2+ BC. The trial is ongoing and has been modified to increase treatment duration to 5mths (10 cycles).
Source:
Title:
Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with docetaxel as first-line (1L) therapy for patients (pts) with advanced HER2-positive breast cancer: Preliminary results from a phase 1b/2 study
Published date:
05/26/2022
Excerpt:
Cohort 1 of this ongoing open-label, Phase 1b/2 study (NCT04276493) is evaluating zani in combination with docetaxel as a 1L therapy in adult females with advanced HER2+ breast cancer...Of the 22-efficacy evaluable (EE) pts, confirmed ORR was 86.4% (95% CI: 65.1, 97.1). The 6 months PFS rate was 90.9% (95% CI: 68.3, 97.7). Zani and docetaxel combination demonstrated antitumor activity in 1L therapy for advanced HER2+ breast cancer...
Secondary therapy:
docetaxel
DOI:
10.1200/JCO.2022.40.16_suppl.1031
Trial ID:
Source:
Title:
Zanidatamab (ZW25), a HER2-targeted bispecific antibody, in combination with chemotherapy (chemo) for HER2-positive breast cancer (BC): Results from a phase 1 study
Published date:
09/10/2021
Excerpt:
Zani in combination with chemo is well tolerated, with encouraging and durable antitumor activity in heavily pretreated (including prior tras, pert, and T-DM1) pts with HER2-positive BC. These data support further investigation of zani as a novel therapeutic for these pts.
Secondary therapy:
Chemotherapy
Trial ID:
