Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer
|ClinicalTrials.gov Identifier: NCT01868503|
Recruitment Status : Terminated (Protocol modification)
First Posted : June 4, 2013
Results First Posted : January 19, 2017
Last Update Posted : June 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||July 2015|
U.S. FDA Resources
Experimental: Lapatinib Plus 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 and will have their blood banked for laboratory biomarker analysis.
Drug: lapatinib ditosylate
Other Names:Radiation: radiation therapy
Undergo radiation therapy
Other Names:Other: laboratory biomarker analysis
- Percentage of Patients Achieving Complete Clinical Response [ Time Frame: Up to 12 weeks ]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 ]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 ]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 ]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 ]Proportion of patients who achieve a pathological complete response will be estimated with 95% exact confidence intervals.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868503
|United States, California|
|Stanford University Cancer Institute|
|Stanford, California, United States, 94305|
|Principal Investigator:||Kathleen Horst||Stanford University Hospitals and Clinics|