Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Auxilio Mutuo Cancer Center Sanofi-Aventis |
---|---|
Information provided by: | Auxilio Mutuo Cancer Center |
ClinicalTrials.gov Identifier: | NCT00830544 |
The purpose of this study is to evaluate the pathological CR rate in breast and lymph nodes of a novel neoadjuvant regimen for invasive breast carcinoma.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Neoadjuvant chemotherapy Drug: Chemotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | Phase II Study of Neoadjuvant Chemotherapy of Breast Cancer |
Estimated Enrollment: | 54 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Experimental chemotherapy using neoadjuvant approach
|
Drug: Neoadjuvant chemotherapy
Docetaxel 75 mg/m2, day 1 Epirubicin 80 mg/m2, day 1 Cyclophosphamide 500 mg/m2, day 1 Navelbine 25 mg/M2 in 250 cc NS over 60 min on day 1 and day 8 Bevacizumab 5 mg/kg in 100 cc NS over 90 min day 1 and day 8 Capecitabine 825 mg/M2 p.o. bid from day 1-14. Trastuzumab
Drug: Chemotherapy
Neoadjuvant chemotherapy
Drug: Neoadjuvant chemotherapy
Experimental chemotherapy regimen
|
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Hematologic (minimal values):
Exclusion Criteria:
Puerto Rico | |
Auxilio Mutuo Cancer Center | Recruiting |
San Juan, Puerto Rico, 00927 | |
Contact: Fernando Cabanillas, MD 787-771-7933 fcabanil@mdanderson.org | |
Contact: Fernando Cabanillas, MD 787-771-7933 fcabanil@mdanderson.org | |
Principal Investigator: Fernando Cabanillas, MD |
Principal Investigator: | Fernando Cabanillas, MD | Auxilio Mutuo Cancer Center |
Responsible Party: | Auxilio Mutuo Cancer Center ( Fernando Cabanillas,MD ) |
Study ID Numbers: | CCAM 07-03 |
Study First Received: | January 27, 2009 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00830544 History of Changes |
Health Authority: | United States: Institutional Review Board |
neoadjuvant chemotherapy breast cancer Breast cancer patients with tumors over one cm |
Docetaxel Capecitabine Vinorelbine Skin Diseases Trastuzumab |
Breast Neoplasms Bevacizumab Cyclophosphamide Epirubicin Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |