Status:
COMPLETED
Lapatinib and Radiation Therapy in Treating Patients With Locally Recurrent or Chemotherapy-Refractory Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity of lapatinib ditosylate and radiotherapy in patients with locally recurrent breast cancer or chemotherapy-refractory, locally advanced or metastatic brea...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00379509
Start Date
April 1 2006
End Date
August 1 2012
Last Update
March 21 2017
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295