Comparison Study of Neoadjuvant Paclitaxel Plus Carboplatin/Epirubicin Treatment in Triple-negative Breast Cancer
|ClinicalTrials.gov Identifier: NCT01276769|
Recruitment Status : Unknown
Verified November 2011 by ZHANG Pin, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : January 13, 2011
Last Update Posted : November 16, 2011
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: Paclitaxel plus carboplatin Drug: Paclitaxel and epirubicin||Phase 2|
It is know that triple-negative breast cancer(TNBC) is more aggressive than non-triple negative breast cancer in both pathological features and clinical prognosis,and there is no standard chemotherapy regimens especially for TNBC. NCCN guidelines recommends Paclitaxel or Epirubicin based regimens as the preferred regimens both for the adjuvant chemotherapy and the treatment of Recurrence and Metastatic breast cancer.The combination of these two drugs is considered as a strong arrangement and therefore,is common used in Triple negative breast cancer patients because of its poor prognosis.
According to the results of some retrospective studies, platinum-based chemotherapy regimens showed a promising sensitive to Triple negative breast cancer patients compared with regimens without platinum.
This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and sensitive to carboplatin.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IIb Trial of Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Epirubicin as Neoadjuvant Treatment in Locally Advanced Triple-negative Breast Cancer|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||July 2012|
Active Comparator: ET
The control arm receive the paclitaxel plus epirubicin
Drug: Paclitaxel and epirubicin
Paclitaxel 175 mg/m2 D3 i.v.,Epirubicin 75mg/m2 D1，2 i.v.
1 cycle = 21days
the experimental arm which receive the paclitaxel combined with carboplatin
Drug: Paclitaxel plus carboplatin
Paclitaxel 175 mg/m2 D1 i.v., carboplatin AUC=5 D2 i.v.
1 cycle = 21days 2-6cycles
- Pathology of specimens derived from the breast modified radical mastectomy/Breast-conserving surgery [ Time Frame: One week after the surgery ]After patients complete the neoadjuvant chemothreapy and receive the surguries,we can get their pathology ，and compare the pCR（pathological complete remission）rates of two amrs
- follow-up the patient every 3-6 months to obtain the 3 year-DFS(disease free survival ) and OS(overall survival ) [ Time Frame: we follow up the patients every 6 month ,up to 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276769
|Cancer institute &Hospital，Chinese Academy of Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: ZHANG Pin, BD +861087788120 email@example.com|
|Contact: YIN Yi, BD firstname.lastname@example.org|
|Principal Investigator: ZHANG Pin, BD|
|Principal Investigator:||ZHANG Pin, BD||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|