Status:
TERMINATED
Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Male Breast Cancer
Recurrent Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 gr...
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 bre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01868503
Start Date
July 1 2013
End Date
July 1 2015
Last Update
June 26 2017
Active Locations (1)
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1
Stanford University Cancer Institute
Stanford, California, United States, 94305