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

Stopped early · Phase 2

Conditions studied: Male Breast Cancer, Recurrent Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

In brief

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.

Key facts

Study ID

NCT01868503

Run by

Stanford University

People needed

7

Starts

2013-07-01

Expected to finish

2015-07-01

Last updated by the study team

2017-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Stanford University Cancer Institute — Stanford, California, United States

Full record on ClinicalTrials.gov

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