A Pilot Study of Neoadjuvant Paclitaxel and Concurrent Radiation With Correlative Molecular Studies in Stage II/III Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
A Pilot Study of Neoadjuvant Paclitaxel and Concurrent Radiation With Correlative Molecular Studies in Stage II/III Breast Cancer
OBJECTIVES:
Primary
- Evaluate the efficacy of paclitaxel and concurrent radiotherapy (as measured by
pathologic response rates) in patients with stage II or III breast cancer.
Secondary
- Evaluate the toxicities of this treatment regimen.
- Correlate paclitaxel-induced tumor response with local recurrence-free survival,
distant disease-free survival, and overall survival.
- Evaluate protein expression profiles by mass spectrometry in biopsy material and blood
specimens collected before and after treatment with paclitaxel.
OUTLINE:
- Neoadjuvant chemotherapy: Patients receive paclitaxel IV over 3 hours on day 1.
Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity.
- Chemoradiotherapy: Beginning 3-4 weeks after completion of neoadjuvant chemotherapy,
patients receive paclitaxel IV over 1 hour twice weekly and undergo radiotherapy once
daily, 5 days a week, for 6½ weeks.
- Surgery: At 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical
resection (e.g., modified radical mastectomy or lumpectomy and axillary node
dissection).
- Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive doxorubicin
hydrochloride IV over 20 minutes and cyclophosphamide IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity.
- Hormonal therapy: After completion of adjuvant chemotherapy, patients with estrogen
receptor- and/or progesterone receptor-positive tumor receive hormonal therapy at the
discretion of the treating physician.
Patients undergo blood and tissue sample collection periodically to analyze changes in cell
cycle by flow cytometry; antibody assays; kinase assays for cyclin B1/CDC2; genetic assays
for p53, p21, and other molecular markers; and protein expression assays by mass
spectrometry.
After completion of study therapy, patients are followed periodically.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically documented invasive carcinoma of the breast*
- Tumor ≥ 2 cm in greatest dimension (e.g., T2-4) and any nodal status (e.g.,
N0-3), including locally advanced disease, as defined by the following criteria:
- Primary tumor ≥ 5 cm
- Tumor of any size with direct extension to the chest wall or skin
- Inflammatory breast cancer (T4d)
- Metastasis to ipsilateral internal mammary node
- Ipsilateral lymph nodes that are clinically fixed to each other or to other
structures (N2) NOTE: *Diagnosis may be made by core or tru-cut biopsies
- Measurable or evaluable tumor
- Measurable disease is defined as any mass that can be reproducibly measured in
two perpendicular dimensions
- Evaluable disease is defined as any lesion visible by mammogram or palpable by
physical exam that does not fit the above criteria of measurability
- Planning to undergo breast conservation surgery
- Willing to undergo AND is a candidate for radiotherapy, in the judgement of the
treating radiation oncologist
- No evidence of distant metastatic disease (e.g., lung, liver, bone, brain)
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Left ventricular ejection fraction ≥ 45%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancies within the past 5 years, except curatively treated
nonmelanomatous skin cancer or carcinoma in situ of the cervix
- No history of hypersensitivity reaction to products containing polysorbate 80 (Tween
80)
- No serious medical illness that, in the judgment of the treating physician, places
the patient at risk
- No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
- Prior tamoxifen as chemoprevention allowed
- No prior radiotherapy to the ipsilateral breast
- Prior radiotherapy to the contralateral breast is allowed
- No prior chemotherapy
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathologic Complete Response Rate
Outcome Time Frame:
9 weeks
Safety Issue:
No
Principal Investigator
A. Bapsi Chakravarthy, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Federal Government
Study ID:
VCC BRE 9936
NCT ID:
NCT00647218
Start Date:
February 2000
Completion Date:
November 2004
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Williamson Medical Center | Franklin, Tennessee 37067 |
| Meharry Medical College | Nashville, Tennessee 37208-3599 |
| Boston Baskin Cancer Center | Memphis, Tennessee 38104 |
| Vanderbilt-Ingram Cancer Cetner | Nashville, Tennessee |
| Jackson-Madison Hospital | Jackson, Tennessee 38301 |
| Methodist Lebonheur Healthcare | Memphis, Tennessee 38104 |
