Status:
COMPLETED
Lapatinib Ditosylate and Capecitabine in Treating Patients With Stage IV Breast Cancer and Brain Metastases
Lead Sponsor:
UNICANCER
Conditions:
Breast Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as c...
Detailed Description
OBJECTIVES: Primary * To assess the objective response rate by volumetric analysis of brain metastasis as assessed by MRI in patients with HER2-positive stage IV breast cancer treated with lapatinib...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Stage IV disease
- At least 1 measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI
- No single brain metastasis that could be treated by surgery
- HER-2 positive primary tumor as defined as IHC3+ or IHC2+ and FISH-positive
- Hormone receptor status: not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥ 3 months
- Absolute Neutrophil Count (ANC) ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10g/dL
- Creatinine ≥ 1.5 times upper limit of normal (ULN)
- Albumin ≥ 2.5 g/dL
- Serum bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)
- ASAT and ALAT ≤ 3 times ULN (≤ 5 times ULN with documented liver metastasis)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception 2 weeks before, during, and for 28 days after completion of study treatment (female) or for 1 week after completion of treatment (male)
- Able to swallow and retain oral medication
- Affiliated to a Social Security System
- No known contraindication to MRI
- No prior or active malignancy, unless disease free for ≥ 10 years
- No other concurrent severe and/or uncontrolled medical disease which could compromise study participation, including any of the following:
- Infection
- Cardiac disease (e.g., uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past year, Left Ventricular EJection Fraction (LVEF) \> grade 2)
- Current active hepatic or biliary disease (except for Gilbert syndrome, asymptomatic gallstones, liver metastasis or stable chronic liver disease per investigator assessment)
- Renal disease
- Active gastrointestinal (GI) tract ulceration, malabsorption syndrome, active uncontrolled ulcerative colitis, or disease significantly affecting GI function
- Severely impaired lung function (e.g., spirometry and diffusion capacity of lung for carbon monoxide (DLCO) ≤ 50% of normal, and O\_2 saturation ≤ 88% at rest on room air)
- No known dihydropyrimidine dehydrogenase deficiency
- No significantly altered mental status prohibiting the understanding of the study, or with psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Not deprived of liberty or placed under the authority of a tutor
- PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior breast cancer treatment (e.g., trastuzumab, chemotherapy, immunotherapy or biological response modifiers, endocrine therapy, or radiotherapy)
- More than 30 days since prior investigational drugs
- More than 14 days since prior and no concurrent strong inhibitors or inducers of the cytochrome P450 isoenzyme 3A4 (CYP3A4) (i.e., clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir)
- No prior whole brain radiotherapy (WBRT) or brain stereotactic radiotherapy
- No prior treatment with capecitabine and/or lapatinib ditosylate
- No prior resection of the stomach or small bowel
- No concurrent systemic treatment or radiation therapy for breast cancer (except corticosteroid, bisphosphonates, or mannitol)
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00967031
Start Date
April 1 2009
Last Update
January 18 2013
Active Locations (1)
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1
Centre Leon Berard
Lyon, France, 69373