Education and Training
Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: lapatinib ditosylate
- radiation: radiation therapy
- other: laboratory biomarker analysis
Eligibility
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
ccto-office@stanford.edu
650-498-7061
Not Recruiting