SWOG clinical trial number
E1199
A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paciltaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients with Axillary Node-Positive or High-Risk Node Negative Breast Cancer
Abbreviated Title
ADJUVANT: Doxorubicin/cyclophosphamide -> paclitaxel or docetaxel
Treatment
Cyclophosphamide
Paclitaxel
Docetaxel
Doxorubicin
AC
Operable, histologically confirmed adenocarcinoma of the female breast with histologically involved lymph nodes (T1, 2 or 3; N1 or 2; M0; AJC Stage IIA, IIB, IIIA) and high risk axillary node-negative disease (T2N0, Stage IIA; T3N0, Stage IIB); for node-negative patients, the primary tumor must measure at least 2.1cm in maximum diameter; at least 6 nodes removed; sentinal node biopsy OK; bilateral disease OK if nodes positive for at least one primary; <= 84 days from surgery; adequate tumor free margins (< 1mm); LCIS < 1 mm from resection margins OK; neutrophils >= 1,500/mm3; platelets >= 100,000/mm3; serum creatinine <= 1.5 mg/dL; total bilirubin <= 1.5 mg/dL; SGOT (AST) <= 2X ULN; >= 18 years of age; no prior heart disease; no prior chemotherapy or RT for this malignancy; prior RT for DCIS OK if completed >= 2 weeks prior to study entry; <= 4 weeks of tamoxifien or SERM OK - tamoxifen or SERM must be discontinued prior to enrollment; no hypersensitivity to paclitaxel or other drugs formulated in Cremophor EL (polyoxethylated castor oil) or to docetaxel or other drugs formulated with polysorbate.
2010
Obesity at diagnosis is associated with inferior outcomes in hormone receptor positive breast cancer
JA Sparano;M Wang;S Martino;V Jones;EA Perez;T Saphner;AC Wolff;GW Sledge;W Wood;J Fetting;NE Davidson San Antonio Breast Cancer Symposium, abst. #S2-1; poster
2009
Black race is associated with a worse outcome in patients with hormone receptor positive, HER2-normal breast cancer treated with adjuvant chemohormonal therapy
J Sparano;M Wang;V Stearns;S Martino;V Jones;E Perez;T Saphner;A Wolff;G Sledge;W Wood;NE Davidson San Antonio Breast Cancer Symposium, abstract #37 (general session)
2008
Weekly paclitaxel in the adjuvant treatment of breast cancer [PMC2743943; PMID18420499]
JA Sparano;M Wang;S Martino;V Jones;EA Perez;TJ Saphner;AC Wolff;GW Sledge;WC Wood;NE Davidson New England Journal of Medicine 358(16):1663-1771
2007
Phase III study of doxorubicin-cyclophosphamide followed by paclitaxel or docetaxel given every 3 weeks or weekly in operable breast cancer: results of Intergroup Trial E1199
JA Sparano;M Wang;S Martino;V Jones;EA Perez;TJ Saphner;AC Wolff;GW Sledge;WC Wood;NE Davidson Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings, 25(185):516
2005
Phase III study of doxorubcin-cyclophosphamide followed by paclitaxel or docetaxel given every 3 weeks or weekly in patients with axillary node-positive or high-risk node-negative breast cancer: results of North American Breast Cancer Intergroup Trial E1199
JA Sparano;M Wang;S Martino;V Jones;EA Perez;TJ Saphner;AC Wolff;GW Sledge;WC Wood;NE Davidson Proceedings of the San Antonio Breast Cancer Symposium 2005, abstract #48
