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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Male Breast Cancer, Recurrent Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

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Trial Information

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


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.


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

- Prior radiotherapy and/or chemotherapy is allowed

- Life expectancy must be greater than 3 months

- Karnofsky performance status (KPS) score >= 70

- Total bilirubin =< 1.5 x institutional upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 x institutional upper limit of normal

- Alkaline phosphatase =< 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

- Ability to understand and willingness to sign a written informed consent document

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients achieving complete clinical response

Outcome Description:

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).

Outcome Time Frame:

Up to 12 weeks

Safety Issue:

No

Principal Investigator

Kathleen Horst

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University Hospitals and Clinics

Authority:

United States: Federal Government

Study ID:

BRS0027

NCT ID:

NCT01868503

Start Date:

July 2013

Completion Date:

Related Keywords:

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

Name

Location
Stanford University Cancer Institute Stanford, California  94305