|
|
 |
|
 |
|
|
|
|
Title:
|
Phase III Trial of Continuous Schedule AC+G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node Negative Breast Cancer - IRB# 04-068B
|
|
Treatments:
|
AC, Cyclophosphamide, Doxorubicin, Filgrastim, Paclitaxel, Trimethoprim sulfa
|
|
Disease Site:
|
Breast
|
|
Disease SubSite:
|
High Risk Node Neg or Node Positive
|
|
Drug Provided:
|
G-CSF
|
|
Comments:
|
Growth factor support with G-CSF(provided). Arms that require Peg-G: Peg G is not provided.SWOG (Automatic Specimen Reimbursement): Specimen Tracking System
|
|
Eligibility:
|
Histologically confirmed diagnosis of operable Stage I, II, or III invasive breast carcinoma with known estrogen or progesterone receptor status; Patients with T4 tumors are not eligible; Patients with bilateral synchronous breast cancer diagnosed within 1 month of each other are eligible; Patients must be high risk by meeting one of the following criteria: (1) tumor >/= 2 cm in greatest diameter (includes both invasive & intraductal component; (2) tumor >/= 1 cm in diater and either ER-/PgR- OR ER+ or PgR+ with a Genomic Health Recurrence Score of >/= 26; (3) one of more axillary or intramammary nodes are positive; Either modified radical mastectomy or local excision of all tumors plus an axillary lymph node dissection or sentinel node resection prior to registration; Patients must have at least 6 axillary or intramammary lymph nodes sampled, with the exception of patients who have a sentinel node procedure with all sampled nodes being uninvolved by malignancy; Patients must be registered within 84 days from final surgical procedure; No prior cytotoxic chemotherapy or chemotherapy with anthracycline, anthrcenedione, or taxane; Co-enrollment in S0230, NSABP B-39, IBCSG 24-02 (SOFT), and IBCSG 25-02 (TEXT) are allowed; No prior radiation therapy except for partial breast irradiation (PBI); PBI must be completed at least 2 wks prior to registration; RT for prior DCIS ok if done 2 wks before registration; No clinical diagnosis for congestive heart failure or angina pectoris; If history of hypertension or age >=60 years, MUGA, echocardiogram scan, or cardiac catheterization must be performed within 42 days prior to registration and LVEF %>= ILLN; Serum creatinine and bilirubin <= IULN; alkaline phosphatase <= 2x IULN; SGOT/SGPT <= 2x IULN; ANC >= 1, 2000; platelet count >= 100,000; No nursing or pregnant women.
|
|
Participating Sites:
|
Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
|
|
|
|
|
 |
|
 |
|
|
|