SWOG clinical trial number
S0338

Phase II Trial of Imatinib Mesylate (Gleevec) (NSC-716051) In Combination With Capecitabine (Xeloda) (NSC-712807) In Metastatic Breast Cancer

Closed
Phase
Accrual
39%
Published
Abbreviated Title
ADVANCED: Imatinib Mesylate Plus Capecitabine for Stage IV Breast Cancer
Activated
06/15/2004
Closed
12/15/2005
Participants
NCORP, Members, Medical Oncologists, Affiliates

Research committees

Breast Cancer

Treatment

STI-571/Imatinib Capecitabine

Eligibility Criteria Expand/Collapse

Histologically or cytologically confirmed Stage IV adenocarcinoma of the breast; must have measurable disease; must have progressed on at least one but no more than two prior chemotherapy regimens for metastatic breast cancer; must not have received prior capecitabine or 5-fluorouracil for metastatic disease; prior hormone treatment for hormone-sensitive tumors is allowed; patients with HER-2/neu positive tumors should have received Herceptin; no prior biologic agents allowed; all prior therapies must have been completed 4 weeks prior to treatment; Age > 18 yrs; PS=0-2; bilirubin w/in normal IL; SGOT(AST)/SGPT(ALT) < 2.5 IULN; platelets > 100,000/microliter, neutrophil > 1,500/microliter, leukocytes > 3,000/microliter, & creatinine w/in normal IL or >60 mL/min w/in 28 days prior to registration; no CNS disease or metastases; RT and major surgery completion > 4 wks prior to study entry; no history of hypersensitivity to imatinib mesylate, capecitabine, or 5-fluorouracil; must not be pregnant; no prior malignancies except basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer in remission > 5yrs; must be HIV negative; must consent to specimen submission.

Publication Information Expand/Collapse

2008

A phase II study of imatinib mesylate and capecitabine in metastatic breast cancer: Southwest Oncology Group study 0338 [PMID19073506]

HK Chew;WE Barlow;KS Albain;D Lew;AM Gown;DF Hayes;J Gralow;GN Hortobagyi;R Livingston Clinical Breast Cancer 8(6):511-515

2006

SWOG 0338: a phase II trial of imatinib mesylate in combination with capecitabine in metastatic breast cancer.

H Chew;B Barlow;K Albain;D Lew;GT Budd;A Gown;J Gralow;RB Livingston Proc of the ASCO, Journal of Clinical Oncology 24(18S):#10529