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Association details:
| Biomarker: | HER-2 negative |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Liporaxel (paclitaxel oral) (Bcl2 inhibitor, Tubulin inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Multi-national, Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®, Oral Paclitaxel) Compared to IV Paclitaxel in Patients with Recurrent or Metastatic Breast Cancer
Excerpt:
...3.Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples (from primary or metastatic site) in any of the following cases (If metastasis is confirmed and it is feasible to obtain the tumor sample from the metastatic site, HER2 status assessment must be performed using the sample from the metastatic site):1)IHC Assessment • IHC score of 0 or 1+ • In case of IHC score of 2+, ISH must be performed to confirm HER2-negative breast cancer2)ISH Assessment• Dual-probe HER2/CEP17 ratio s who have a life expectancy of ≥12 weeks. ...
Trial ID:
Source:
Title:
Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
Excerpt:
...Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples 3....
Trial ID:
More C2 evidence
Source:
Title:
A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Oral Paclitaxel (DHP107) Compared to IV Paclitaxel as First-line Therapy in Patients with Recurrent or metastatic HER2 negative Breast Cancer
Excerpt:
...1) Subjects who are ≥ 19 years of age on the date of written informed consent.2) Subjects with confirmation of primary, recurrent or metastatic HER2 negative breast cancer based on histopathology examination (tumor characteristics should be confirmed by histological or cytological evaluation). ...
Trial ID:
Less C2 evidence
Source:
Title:
Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study)
Published date:
12/15/2021
Excerpt:
This multicenter, phase II study using a Simon's two-stage design investigated the efficacy and safety of DHP107 200 mg/m2 administered orally twice daily on days 1, 8, and 15 every 4 weeks for the first-line treatment of recurrent or metastatic HER2-negative breast cancer....Objective response rate was 55% (17 patients)...Disease control rate (partial response and stable disease) was 74%...DHP107 showed promising efficacy and acceptable tolerability in this phase II study...
DOI:
10.1177/17588359211061989
Trial ID:
