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

Launched by STANFORD UNIVERSITY · May 30, 2013

Keywords

ClinConnect Summary

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 radiothera...

Gender

ALL

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