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Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer

Primary Purpose

Male Breast Cancer, Recurrent Breast Cancer, Stage IIIA Breast Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

lapatinib ditosylate

radiation therapy

laboratory biomarker analysis

About this trial

This is an interventional treatment trial for Male Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lapatinib Plus Radiation Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Patients Achieving Complete Clinical Response

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).

Secondary Outcome Measures

Feasibility of Assessing the Effects of Lapatinib and Radiation Therapy on BCSCs Using Flow Cytometry and SCGEP

Defined as the percentage of biopsy specimens for which the SCGEP assay achieves a non-zero number.

Change in the Proportion of BCSCs

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

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

Proportion of patients who achieve a pathological complete response will be estimated with 95% exact confidence intervals.

Full Information

NCT ID

NCT01868503

First Posted

May 30, 2013

Last Updated

June 21, 2017

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01868503

Brief Title

Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer

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 Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Protocol modification

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Male Breast Cancer, Recurrent Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lapatinib Plus Radiation Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

lapatinib ditosylate

Other Intervention Name(s)

GSK572016, GW-572016, GW2016, Lapatinib, Tykerb

Intervention Description

Given PO

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Other Intervention Name(s)

irradiation, radiotherapy, therapy, radiation

Intervention Description

Undergo radiation therapy

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Percentage of Patients Achieving Complete Clinical Response

Description

Time Frame

Up to 12 weeks

Secondary Outcome Measure Information:

Title

Feasibility of Assessing the Effects of Lapatinib and Radiation Therapy on BCSCs Using Flow Cytometry and SCGEP

Description

Defined as the percentage of biopsy specimens for which the SCGEP assay achieves a non-zero number.

Time Frame

12 weeks

Title

Change in the Proportion of BCSCs

Description

Time Frame

Baseline to 12 weeks

Title

Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Description

Adverse events will be tabulated by organ system and severity.

Time Frame

Up to 12 weeks

Title

Pathologic Complete Response Rate for Those Patients Undergoing Surgical Resection Defined as no Evidence of Residual Tumor in the Breast and Lymph Nodes

Description

Proportion of patients who achieve a pathological complete response will be estimated with 95% exact confidence intervals.

Time Frame

Up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen Horst

Organizational Affiliation

Stanford University Hospitals and Clinics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University Cancer Institute

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer

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