Spots Global Cancer Trial Database for The Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Breast Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: The Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Breast Cancer

Official Title: A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Early Operable Breast Cancer

Study ID: NCT03647280

Conditions

Breast Cancer

Interventions

Abraxane

Epirubicin

Study Description

Brief Summary: Some studies have demonstrated the efficacy of Abraxane in treating breast cancer in both adjuvant and metastatic settings. Few data is available on Abraxane in neoadjuvant treatment for breast cancer. The aim of this project is to evaluate tailored primary systemic therapy with weekly Abraxane (125mg/m2) Combined With Q3week Epirubicin (100mg/m2) in early operable (stage of T2-4N0-3M0) breast cancer. This study will be an open label non randomized, single arm, single center study.

Detailed Description: The hypothesis is that tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is feasible and achieves high response rates. It is proposed that 50 patients will be enrolled in this study. The target population is women with early breast cancer (stage of T2-4N0-3M0) who are eligible for primary systemic therapy. The primary objective of the trial is to determine the overall response rate. Secondary endpoints will include response rates in axillary lymph nodes, safety and tolerability and the rate of breast conservation.