Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer
This phase II trial studies how well lapatinib ditosylate and radiation therapy work in treating patients with locally advanced or locally recurrent breast cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving lapatinib ditosylate together with radiation therapy may be an effective treatment for breast cancer.
Male Breast Cancer
Recurrent Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Drug: lapatinib ditosylate
Radiation: radiation therapy
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study to Investigate Concurrent Lapatinib and Radiotherapy in Locally Advanced or Locally Recurrent Breast Cancer and the Impact on Breast Cancer Stem Cells|
- Percentage of patients achieving complete clinical response [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]Complete clinical response will be defined as the absence of tumor on the chest wall, in the treated breast, or in the nodal regions as assessed by clinical examination +/- radiographic imaging (if clinically indicated).
- Feasibility of assessing the effects of lapatinib and radiation therapy on BCSCs using flow cytometry and SCGEP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Defined as the percentage of biopsy specimens for which the SCGEP assay achieves a non-zero number.
- Change in the proportion of BCSCs [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]Defined as the difference between the percentage of BCSCs before and after treatment. Proportion of biopsy samples that are evaluable for BCSCs will be estimated along with 95% exact confidence intervals. BCSC results will be summarized using medians and interquartile ranges. Changes in BCSCs will be assessed using the Wilcoxon signed rank test.
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]Adverse events will be tabulated by organ system and severity.
- Pathologic complete response rate for those patients undergoing surgical resection defined as no evidence of residual tumor in the breast and lymph nodes [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]Proportion of patients who achieve a pathological complete response will be estimated with 95% exact confidence intervals.
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||January 2021 (Final data collection date for primary outcome measure)|
Experimental: Treatment (lapatinib ditosylate, radiation therapy)
Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.
Drug: lapatinib ditosylate
Other Names:Radiation: radiation therapy
Undergo radiation therapy
Other Names:Other: laboratory biomarker analysis
I. To assess the clinical complete response rate (CR) after concurrent lapatinib (lapatinib ditosylate) and radiotherapy in patients with locally advanced or locally recurrent breast cancer that is refractory to chemotherapy.
I. To evaluate the feasibility of assessing breast cancer stem cells (BCSCs) using flow cytometry and single cell gene expression profiling (SCGEP).
II. To determine the change in the proportion of BCSCs after combined modality therapy.
III. To evaluate the safety and efficacy of the combination of lapatinib and radiotherapy.
IV. To assess the pathologic complete response rate (pCR) in those undergoing surgical resection.
Patients receive lapatinib ditosylate orally (PO) once daily (QD) on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.
After completion of study treatment, patients are followed up at 2-4 weeks and then at 6-12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868503
|United States, California|
|Stanford University Cancer Institute||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Amanda Simmons 650-724-4606 email@example.com|
|Principal Investigator: Kathleen C. Horst|
|Principal Investigator:||Kathleen Horst||Stanford University Hospitals and Clinics|