Paclitaxel and Radiation Therapy in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00647218|
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : February 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Post-operative adjuvant therapy Drug: neoadjuvant therapy Procedure: therapeutic surgical procedure Radiation: Radiation therapy with concurrent Paclitaxel Drug: Hormonal Therapy||Not Applicable|
- Evaluate the efficacy of paclitaxel and concurrent radiotherapy (as measured by pathologic response rates) in patients with stage II or III breast cancer.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Neoadjuvant Paclitaxel and Concurrent Radiation With Correlative Molecular Studies in Stage II/III Breast Cancer|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||November 2004|
|Actual Study Completion Date :||November 2004|
Drug: Post-operative adjuvant therapy
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.
Other Name: None notedDrug: neoadjuvant therapy
Paclitaxel 175 mg/m2 IV every 3 weeks x 3 cycles
Other Name: None notedProcedure: therapeutic surgical procedure
Modified radical mastectomy or segmental mastectomy plus axillary dissection 6-8 weeks following completion of chemotherapy/Radiotherapy.
Other Name: None notedRadiation: Radiation therapy with concurrent Paclitaxel
Radiation to breast 4680 cGy/26 fractions with concurrent Paclitaxel 30 mg/m2, twice per week
Other Name: None notedDrug: Hormonal Therapy
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.
- Pathologic Complete Response Rate [ Time Frame: 9 weeks ]
- Toxicity paclitaxel and radiation [ Time Frame: at 18 weeks ]
- Correlation of tumor response with local recurrence-free survival, distant disease-free survival, and overall survival [ Time Frame: at time of disease progression or death by any cause ]
- Protein expression profiles as measured by mass spectrometry before and after treatment with paclitaxel [ Time Frame: Baseline and 18 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647218
|United States, Tennessee|
|Williamson Medical Center|
|Frankling, Tennessee, United States, 37067|
|Jackson, Tennessee, United States, 38301|
|Boston Baskin Cancer Center|
|Memphis, Tennessee, United States, 38104|
|Methodist Lebonheur Healthcare|
|Memphis, Tennessee, United States, 38104|
|Meharry Medical College|
|Nashville, Tennessee, United States, 37208|
|Vanderbilt-Ingram Cancer Cetner|
|Nashville, Tennessee, United States|
|Study Chair:||A. Bapsi Chakravarthy, MD||Vanderbilt-Ingram Cancer Center|