Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment.

PURPOSE: This clinical trial is studying how well genetic testing works in predicting response to paclitaxel in women who have unresected breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion:

• Histologically confirmed infiltrating carcinoma of the breast

• Unresected disease

• High-risk (> 50% risk of relapse) disease, including any of the following high-risk markers:

• Estrogen receptor- and progesterone receptor- negative

• Palpable axillary lymph nodes

• Grade 3 histology

• S phase fraction > 10%

• Ki67 > 30%

• Disease that warrants combination therapy with doxorubicin, cyclophosphamide, and paclitaxel

• HER2/neu negative or positive

• Hormone receptor status:

• Not specified

Menopausal status

• Known

Performance status

• ECOG 0-2

• Absolute neutrophil count > 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin ≤ 1. 5 times normal (except for patients with known Gilbert's disease)

• Creatinine ≤ 1.5 times normal

Exclusion:

• uncontrolled congestive heart failure

• myocardial infarction within the past 6 months

• unstable angina

• uncontrolled hypertension

• pregnant or nursing

• serious bacterial, viral, or fungal infection requiring ongoing treatment

• severe peripheral neuropathy

• poor psychiatric risk

• history of any other known serious co-morbid medical or psychiatric condition

• prior cytotoxic therapy for breast cancer