Breast Cancer
Conditions
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, stage IA breast cancer, stage IB breast cancer, HER2-negative breast cancer, HER2-positive breast cancer
Brief 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.
Detailed description
OBJECTIVES: Primary * Determine the feasibility of accruing women with unresected infiltrating carcinoma of the breast to a clinical trial involving serial breast biopsies and administration of neoadjuvant paclitaxel before formal assessment of axillary lymph node status. * Determine a standard protocol template for gene microarray analysis, in terms of the timing and method of collecting tissue samples, before and after administration of neoadjuvant paclitaxel in these patients. * Determine the safety and efficacy of tissue sampling in these patients. Secondary * Identify gene(s) or gene clusters that exhibit significant differences between responding and non-responding tumors before treatment with neoadjuvant paclitaxel in these patients. * Identify gene(s) or gene clusters that exhibit changes in gene expression before and after the administration of neoadjuvant paclitaxel in these patients. * Compare significant differences in gene expression between responding and non-responding tumors in patients treated with this drug. * Develop, preliminarily, a statistical model utilizing individual genes and/or gene clusters that can best predict response to paclitaxel in these patients. OUTLINE: This is a pilot, multicenter study. Patients undergo core needle breast biopsy within 14 days before starting neoadjuvant paclitaxel treatment. Patients receive neoadjuvant paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo core needle breast biopsy 48 hours after the first administration of paclitaxel, upon completion of course 1, and either upon completion of the last course (in patients with clinical or radiographic evidence of residual disease) or during definitive breast surgery. Biopsy samples are analyzed for gene expression by gene microarray analysis. Patients are followed for survival. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Interventions
DRUGpaclitaxel
subjects will receive paclitaxel neoadjuvantly
GENETICmicroarray analysis
subjects will have a biopsy to collect tissue for gene microarray analysis
PROCEDUREbiopsy
All subjects will have a biopsy to collect tissue
PROCEDUREneoadjuvant therapy
paclitaxel is given neoadjuvantly
DRUGPaclitaxel
All patients will receive paclitaxel neoadjuvantly
Sponsors
National Cancer Institute (NCI)
Georgetown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response | 3 months | Due to the early termination of the study, this data for this outcome was not collected. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel Paclitaxel given before surgery
paclitaxel: subjects will receive paclitaxel neoadjuvantly
microarray analysis: subjects will have a biopsy to collect tissue for gene microarray analysis
biopsy: All subjects will have a biopsy to collect tissue
neoadjuvant therapy: paclitaxel is given neoadjuvantly
Paclitaxel: All patients will receive paclitaxel neoadjuvantly | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | PI left institution and study was close | 22 |
Baseline characteristics
| Characteristic | Paclitaxel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Overall Response
Due to the early termination of the study, this data for this outcome was not collected.
Time frame: 3 months