- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01868503
Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with histologically or cytologically confirmed locally advanced breast cancer that is refractory to chemotherapy or other therapeutic agents or with a history of breast cancer with new evidence of a local recurrence (defined as a chest wall or breast recurrence and/or nodal recurrence); the diagnosis will be made based on clinical and pathologic features
- Patients must be >18 years of age.
- Karnofsky Performance Status (KPS) score > 70
Patts must have normal organ function as defined below:
- total bilirubin < 1.5 x institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) < 2.5 x institutional upper limit of normal
- creatinine < 1.5 x institutional upper limit of normal
- Patients must have left-ventricular ejection fraction > 50% at baseline.
Exclusion Criteria:
- Patients who have contraindications to radiotherapy, such as scleroderma, dermatomyositis, or severe cutaneous manifestations of systemic lupus erythematosus (SLE)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
- Women who are pregnant or lactating, as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the duration of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
Undergo radiation therapy
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
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.
|
Baseline to 12 weeks
|
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.
|
Up to 12 weeks
|
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.
|
Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathleen Horst, Stanford University Hospitals and Clinics
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRS0027
- P30CA124435 (U.S. NIH Grant/Contract)
- NCI-2013-01065 (REGISTRY: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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