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Molecular Triaging of Newly Diagnosed Breast Cancer
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2010
CompletedFirst Posted
Study publicly available on registry
July 9, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedJuly 31, 2012
July 1, 2012
July 7, 2010
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathological Response Rate in Patients
Response is defined as pathologic complete (pCR/RCB-0) or near complete (RCB-I) response pathologic finding after completion of chemotherapy.
Every 3-4 weeks during chemotherapy.
Study Arms (3)
Group 1: ER-Positive
EXPERIMENTALParticipants 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.
Group 2: ER-Negative
EXPERIMENTALParticipants with ER-negative cancers (randomized between Group 2 \& Group 3), Standard T/FAC or T/FEC chemotherapy before surgery.
Group 3: ER-Negative + Bevacizumab
EXPERIMENTALParticipants 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.
Interventions
80 mg/m2 by vein over about 1-2 hours once every 7 days x 12 courses.
500 mg/m2 for 4 courses (once every 7 days)
50 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments
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.
500 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments.
10 mg/kg intravenously every 2 weeks, discontinued 6 weeks before surgery (i.e. after 3rd course of FEC or FAC)
Eligibility Criteria
You may qualify if:
- Patients 18 years of age or older with histologically confirmed HER2-normal (defined as fluorescence in situ hybridization, FISH \< 2.2 or immunohistochemistry, IHC \<3+ if FISH result is not available) invasive carcinoma of the breast for whom systemic adjuvant therapy is clinically indicated.
- Patients must have intact cancer in the breast and intact regional lymph nodes (diagnostic core needle or fine needle biopsies are allowed).
- Routine estrogen, progesterone and HER-2 receptor determination must be performed before starting therapy.
- Patients with prior history of breast cancer are eligible.
- Patients with bilateral breast cancers are eligible.
- Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of starting chemotherapy. Patients must agree to barrier contraception (condom) while on study.
- Patients must agree to undergo pretreatment needle biopsy of the primary tumor in the breast for molecular profiling.
- Patients must agree to undergo surgery at MDACC and if assigned to bevacizumab containing chemotherapy it must be administered at MDACC.
You may not qualify if:
- Patients for whom anthracycline or paclitaxel chemotherapies are contraindicated, including: uncompensated congestive heart failure, myocardial infarction within the past 12 months, pre-existing peripheral neuropathy \> grade 2, prior doxorubicin therapy with \> cumulative dose of 240 mg/m\^2
- Women who had lumpectomy or surgical partial excisional biopsy of the cancer, or sentinel lymph node biopsy of a positive node, before starting preoperative therapy.
- Proteinuria within 1 months of starting therapy as demonstrated by either (a) Urine protein:creatinine (UPC) ratio \>/= 1.0 or (b) proteinuria \>/= 2+ by urine dipstick test. Patients discovered to have \>/=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate \</= 1g of protein in 24 hours to be eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lajos Pusztai, MD, DPHIL
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2010
First Posted
July 9, 2010
Study Start
September 1, 2010
Last Updated
July 31, 2012
Record last verified: 2012-07