Paclitaxel and Radiation Therapy in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer

NACompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

February 29, 2000

Primary Completion Date

November 30, 2004

Study Completion Date

November 30, 2004

Conditions
Breast Cancer
Interventions
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.

DRUG

neoadjuvant therapy

Paclitaxel 175 mg/m2 IV every 3 weeks x 3 cycles

PROCEDURE

therapeutic surgical procedure

Modified radical mastectomy or segmental mastectomy plus axillary dissection 6-8 weeks following completion of chemotherapy/Radiotherapy.

RADIATION

Radiation therapy with concurrent Paclitaxel

Radiation to breast 4680 cGy/26 fractions with concurrent Paclitaxel 30 mg/m2, twice per week

DRUG

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.

Trial Locations (6)

37067

Williamson Medical Center, Frankling

37208

Meharry Medical College, Nashville

38104

Boston Baskin Cancer Center, Memphis

Methodist Lebonheur Healthcare, Memphis

38301

Jackson-Madison Hospital, Jackson

Unknown

Vanderbilt-Ingram Cancer Cetner, Nashville

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Vanderbilt-Ingram Cancer Center

OTHER

NCT00647218 - Paclitaxel and Radiation Therapy in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer | Biotech Hunter | Biotech Hunter