Lapatinib and Radiation Therapy in Treating Patients With Locally Recurrent or Chemotherapy-Refractory Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Lapatinib 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 together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with radiation therapy in treating patients with locally recurrent or chemotherapy-refractory locally advanced or metastatic breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lapatinib

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer meeting 1 of the following criteria:

• Locally recurrent disease

• Locally advanced disease AND meets the following criterion:

• Chemotherapy-refractory disease (achieved < partial response to ≥ 3 courses of neoadjuvant chemotherapy)

• Metastatic disease

• Evaluable disease by exam and/or imaging studies

• Amenable to serial biopsies by skin punch, core biopsy, or fine-needle aspiration

• Unresectable disease after standard neoadjuvant chemotherapy

• Resectability must be determined by a surgical oncologist prior to treatment

• Stable CNS metastases allowed

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Male or female

• Menopausal status not specified

• Life expectancy > 12 weeks

• ECOG performance status 0-2

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to swallow and retain oral medication

• WBC ≥ 3,000/mm³

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Total bilirubin normal

• AST and ALT ≤ 2.5 times upper limit of normal

• Creatinine normal OR creatinine clearance ≥ 60 mL/min

• Cardiac ejection fraction normal by ECHO or MUGA

• No other malignancy within the past 5 years

• No concurrent disease or condition that would preclude study participation

• No ongoing coagulopathy

• No active severe infection

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior therapy

• At least 3 weeks since prior and no other concurrent systemic therapy for breast cancer

• At least 14 days since prior and no concurrent herbal or alternative medicine

• At least 14 days since prior and no concurrent dietary supplement

• At least 14 days since prior CYP3A4 inducers

• At least 7 days since prior CYP3A4 inhibitors

• No antacid within 1 hour before or after study drug administration

• Concurrent bisphosphonate allowed

• No concurrent oral glucocorticosteroid > 1.5 mg of dexamethasone (or equivalent)