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

Not Recruiting

Trial ID: NCT01868503


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.

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

Stanford Investigator(s)

Maximilian Diehn, MD, PhD
Maximilian Diehn, MD, PhD

Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)


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

   - 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


drug: lapatinib ditosylate

radiation: radiation therapy

other: laboratory biomarker analysis

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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