Saracatinib in Treating Patients With Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed By Surgery
This phase II trial is studying saracatinib to see how well it works in treating patients with metastatic or locally advanced breast cancer that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Estrogen Receptor-negative Breast Cancer
Male Breast Cancer
Progesterone Receptor-negative Breast Cancer
Recurrent Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of AZD0530 in Hormone Receptor-Negative, Metastatic or Unresectable, Locally Advanced Breast Cancer|
- Disease control rate (DCR) [ Time Frame: After 24 weeks of study therapy ] [ Designated as safety issue: No ]DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon's two-stage optimal design will be used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allows for early termination of the study.
- Overall response rate (CR and PR) [ Time Frame: Every 12 weeks during treatment, and up to 24 weeks after completion of study treatment ] [ Designated as safety issue: No ]The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Summary statistics such as mean, median, counts and proportions will be. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, t-tests or logistic regression analyses as appropriate.
- Progression-free survival (PFS) [ Time Frame: Up to 4 weeks after completion of study treatment ] [ Designated as safety issue: No ]PFS is defined as the duration of time from start of treatment to the time of progression or death. Progression free survival will be estimated using Kaplan-Meier methodology.
- Toxicity rate [ Time Frame: Weekly during course 1 and then once per each course, and at 4 weeks after completion of study treatment ] [ Designated as safety issue: Yes ]Frequency of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
- Patterns of circulating tumor cells (CTCs) in response to therapy [ Time Frame: Baseline and week 1 of courses 2 and 4 ] [ Designated as safety issue: No ]The statistical analyses will be primarily descriptive. Pretreatment levels and levels after courses 1 and 3 will be summarized for all patients. Overall trends will be examined by plotting the average CTC level at each timepoint by time. Both the patient-specific and overall plots over time will be visually assessed for trends. A paired t-test will be done to examine whether response (0=no response or progression of disease, 1=response) is related to the change between baseline levels of CTC and CTC levels after courses 1 and 3.
- IL-6 [ Time Frame: Baseline, week 1 of course 3, after completion of courses1 and 3 ] [ Designated as safety issue: No ]The statistical analyses of serum IL-6 will be primarily descriptive. Pretreatment levels of IL-6, levels at Course 1 Week 3, and after Courses 1 and 3 will be summarized for all patients. Overall trends will be examined by plotting the average IL-6 level at each timepoint by time. Both the patient-specific and overall plots over time will be visually assessed for trends. A paired t-test will be done to examine whether response (0=no response or progression of disease, 1=response) is related to the change between baseline levels and levels after Course 1 Week 3.
|Study Start Date:||October 2007|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other Name: AZD0530Other: laboratory biomarker analysis
I. To estimate the disease control rate of AZD0530 (saracatinib) in patients with metastatic breast cancer.
I. To estimate the efficacy of AZD0530 in terms of overall response rate (complete and partial response) and progression free survival.
II. To describe the toxicity profile of AZD0530 in this patient population. III. To prospectively explore changes in circulating tumor cells from pre-treatment levels in patients receiving AZD0530.
Patients receive saracatinib orally (PO) on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Clifford Hudis||Memorial Sloan-Kettering Cancer Center|