Molecular Triaging of Newly Diagnosed Breast Cancer

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01159236
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    80 mg/m2 by vein over about 1-2 hours once every 7 days x 12 courses.
  • Fluorouracil — DRUG
    500 mg/m2 for 4 courses (once every 7 days)
  • Doxorubicin — DRUG
    50 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments
  • Epirubicin — DRUG
    100 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments, may be given instead of Doxorubicin in Group 1 and 2.
  • Cyclophosphamide — DRUG
    500 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments.
  • Bevacizumab — DRUG
    10 mg/kg intravenously every 2 weeks, discontinued 6 weeks before surgery (i.e. after 3rd course of FEC or FAC)

Study Details

The goal of this clinical research study is to learn if using "gene signatures" can be an effective way to decide the best treatment for breast cancer patients. Gene signatures may be able to help researchers predict who will respond to chemotherapy given before surgery.

Key Dates

First listed
Jul 9, 2010
Start date
Sep 30, 2010
Status verified
Jul 2012

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: ER-Positive
    Participants with Estrogen Receptor (ER)-Positive breast cancers receive Standard T/FAC or T/FEC chemotherapy before surgery. T/FAC or T/FEC: Combination chemotherapy with sequential paclitaxel (80 mg/m2) weekly x 12 weeks followed by 5-fluorouracil (500 mg/m2), cyclophosphamide (500 mg/m2) and doxorubicin (50 mg/m2) or epirubicin (100 mg/m2) (FAC or FEC) once every 3 weeks for 4 treatments.
  • Experimental: Group 2: ER-Negative
    Participants with ER-negative cancers (randomized between Group 2 \& Group 3), Standard T/FAC or T/FEC chemotherapy before surgery.
  • Experimental: Group 3: ER-Negative + Bevacizumab
    Participants with ER-negative cancers (randomized between Group 2 \& Group 3), T/FEC chemotherapy combined with 10 mg Bevacizumab every 2 weeks during first 3 treatments before surgery.

Primary Outcome Measure

Pathological Response Rate in Patients [ Time Frame: Every 3-4 weeks during chemotherapy. ]

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