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
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]
2006
SWOG 0338: a phase II trial of imatinib mesylate in combination with capecitabine in metastatic breast cancer.
Other Clinical Trials
SWOG Clinical Trial Number
S2206
A Randomized trial of neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone for Adults with MammaPrint Ultrahigh (MP2) hormone receptor (HR) positive /Human Epidermal Growth Factor receptor (HER2) negative stage II-III breast cancer
Research Committee(s)
Breast Cancer
Symptom Control and Quality of Life
Activated
10/30/2023
Accrual
9%
Open
Phase
SWOG Clinical Trial Number
S2212
TIL Adapted Neo adjuvant Chemotherapy Optimization in Triple negative breast cancer (SCARLET)
Research Committee(s)
Breast Cancer
Activated
07/21/2023
Accrual
16%
Open
Phase
SWOG Clinical Trial Number
CTSU/NRG-BR007
A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score </= 18 Breast Cancer
Research Committee(s)
Breast Cancer
Activated
06/07/2021
Open
Phase