Neoadjuvant Epirubicin, Cyclophosphamide, and Paclitaxel With or Without Gemcitabine in Treating Women Who Are Undergoing Surgery for Early Breast Cancer
NCT00070278 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2013-08-07
Summary
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer.
PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating women who are undergoing surgery for early invasive breast cancer.
Conditions
Interventions
- DRUG
- DRUG
-
epirubicin hydrochloride
- DRUG
-
gemcitabine hydrochloride
- DRUG
- GENETIC
-
comparative genomic hybridization
- GENETIC
-
microarray analysis
- GENETIC
-
mutation analysis
- PROCEDURE
-
conventional surgery
- PROCEDURE
-
neoadjuvant therapy
Sponsors & Collaborators
-
Cambridge University Hospitals NHS Foundation Trust
lead OTHER
Principal Investigators
-
Helena Earl, MBBS, PhD, FRCP · Cambridge University Hospitals NHS Foundation Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-31
- Primary Completion
- 2007-09-30
Countries
- United Kingdom
Study Locations
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