Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer (CBCRT01)
|ClinicalTrials.gov Identifier: NCT01479036|
Recruitment Status : Unknown
Verified November 2011 by Xijing Hospital.
Recruitment status was: Recruiting
First Posted : November 24, 2011
Last Update Posted : November 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: docetaxel and epirubicin Drug: docetaxel and epirubicin plus endostatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase Ⅲ Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-Line Therapy in Patients With Breast Cancer|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||February 2015|
Active Comparator: docetaxel and epirubicin
DE chemotherapy alone
Drug: docetaxel and epirubicin
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, totally 3 cycles
Experimental: docetaxel and epirubicin plus endostatin
chemotherapy plus endostatin
Drug: docetaxel and epirubicin plus endostatin
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostatin 7.5mg/m2, IV (in the vein) on 1st to 14th days of each 21 day cycle; every 3 weeks, totally 3 cycles
Other Name: Endostatin, Simcere-Medgenn (No. S20050088)
- Clinical/pathological response [ Time Frame: 3 years ]The clincial response will be evaluated according to RECIST criteria. The parameters of tumor metabolism and blood supply, as demonstrated by PET, MRA and CEUS, will be collected and analysed.
- Number of participants with adverse events [ Time Frame: 3 years ]The number of participants with adverse events will be recorded and analysed.
- Quality of life [ Time Frame: 3 years ]Quality of life is scored using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Questionnaire (QLQ30) at study entry and prior to surgery.
- Number of adverse events reported during neoadjuvant therapy [ Time Frame: 3 years ]The adverse events during neoadjuvant therapy will be graded using the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 2.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479036
|Contact: Jianghao Chen, MD, PhDemail@example.com|
|Contact: Qing Yao, MDfirstname.lastname@example.org|
|Xi'an, Shaanxi, China, 710032|
|Contact: Aidong Wen, MD 86-29-84775475 ext 8037 email@example.com|
|Principal Investigator: Jianghao Chen, MD, PhD|
|Principal Investigator:||Jianghao Chen, MD, PhD||Xijing Hospital|
|Study Director:||Ling Wang, MD||Xijing Hospital|