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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-BRE-9936 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying how well giving paclitaxel together with radiation therapy works in treating patients undergoing surgery for stage II or stage III breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-operative adjuvant therapy | Drug | Adriamycin 60 mg/m2 IV over 20 minutes and Cytoxan 600 mg/m2 IV over 1 hour will be given every three weeks for 4 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity paclitaxel and radiation | at 18 weeks | |
| Correlation of tumor response with local recurrence-free survival, distant disease-free survival, and overall survival | at time of disease progression or death by any cause |
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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:
Measurable or evaluable tumor
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:
PRIOR CONCURRENT THERAPY:
Prior tamoxifen as chemoprevention allowed
No prior radiotherapy to the ipsilateral breast
No prior chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| A. Bapsi Chakravarthy, MD | Vanderbilt-Ingram Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Williamson Medical Center | Frankling | Tennessee | 37067 | United States | ||
| Jackson-Madison Hospital |
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|
| neoadjuvant therapy | Drug | Paclitaxel 175 mg/m2 IV every 3 weeks x 3 cycles |
|
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| therapeutic surgical procedure | Procedure | Modified radical mastectomy or segmental mastectomy plus axillary dissection 6-8 weeks following completion of chemotherapy/Radiotherapy. |
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| Radiation therapy with concurrent Paclitaxel | Radiation | Radiation to breast 4680 cGy/26 fractions with concurrent Paclitaxel 30 mg/m2, twice per week |
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| Hormonal Therapy | Drug | After completion of postoperative adjuvant Adriamycin and Cytoxan, hormonal therapy should be given at the discretion of the treating physician for all post-menopausal ER and/or PR positive patients. It is also recommended for pre-menopausal patients who are ER and/or PR positive. |
|
| Protein expression profiles as measured by mass spectrometry before and after treatment with paclitaxel | Baseline and 18 weeks |
| Jackson |
| Tennessee |
| 38301 |
| United States |
| Boston Baskin Cancer Center | Memphis | Tennessee | 38104 | United States |
| Methodist Lebonheur Healthcare | Memphis | Tennessee | 38104 | United States |
| Meharry Medical College | Nashville | Tennessee | 37208 | United States |
| Vanderbilt-Ingram Cancer Cetner | Nashville | Tennessee | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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