Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer

Summary

This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin. The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer. The primary endpoint of the study is to to assess Pathological complete response rate（pCR）using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).. The total number of patients to be included in this study is 60 patients. The duration of the study, from first patient visit to last patient visit will be approximately 19 months.

Timeline

Start

2018-11-26

Primary completion

2019-11-30

Completion

2020-02-01

Publications

• Liu Y, Fan L, Wang ZH, Shao ZM. Nab-paclitaxel Followed by Dose-dense Epirubicin/Cyclophosphamide in Neoadjuvant Chemotherapy for Triple-negative Breast Cancer: A Phase II Study. Oncologist. 2023 Jan 18;28(1):86-e76. doi: 10.1093/oncolo/oyac223.

Drugs

Indications