A multicenter phase II clinical trial assessing the efficacy of the combination of lapatinib and capecitabine in patients with non pretreated brain metastasis from HER2 positive breast cancer. - LANDSCAPE
- Conditions
- Patient with non penetrated brain metastasis from HER2 positive breast cancer.MedDRA version: 9.1Level: LLTClassification code 10006128Term: Brain metastases
- Registration Number
- EUCTR2008-001084-10-FR
- Lead Sponsor
- FNCLCC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. Histologically confirmed invasive breast cancer with stage IV disease.
2. HER-2 positive primary tumor, defined as : IHC3+, or IHC2+ and FISH positive.
3. At least one measurable CNS lesion = 10 mm on T1-weighted gadolinium-enhanced MRI.
4. At least two weeks from any specific breast cancer treatment (such as Trastuzumab,
chemotherapy, immunotherapy/biological response modifiers, endocrine therapy and
radiotherapy).
5. Adequate hematologic function (ANC = 1.0x109/L, platelets = 100 000 ; Hb = 10g/l), renal
function (creatinine = 1.5 UNL) and hepatic function (albumin = 2.5 g/dL ;
serum bilirubin = 1.5x ULN unless due to Gilbert’s syndrome ; ASAT and ALAT = 5x ULN if
documented liver metastases or = 3x ULN without liver metastases)
6. Patients able to swallow and retain oral medication.
7. At least 18 years old.
8. ECOG Performance Status of 0 to 2.
9. Life expectancy = 3 months.
10. Potentially reproductive patients must agree to use an effective contraceptive method while
on treatment, beginning 2 weeks before the first dose of investigational product and for 28
days after the final dose of investigational product for women. Males able to father a child
must practice adequate methods of birth control or practice complete abstinence from
intercourse from the first dose of investigational treatment until one week after the final
dose of investigational treatment.
11. Women of childbearing potential must have a negative serum pregnancy test within 14
days of enrollment and/or urine pregnancy test 48 hours prior to the administration of the
first study treatment.
12. Patients must be affiliated to a Social Security System.
13. Patient information and written informed consent form signed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Previous whole brain radiotherapy (WBRT) or brain stereotactic radiotherapy.
2) Planned or concurrent systemic treatment or radiation therapy for breast cancer (other that
corticosteroid, biphosphonates or mannitol).
3) Single brain metastasis which could be treated by surgery.
4) Known contra-indication to MRI.
5) Active concurrent malignancy. If there is a history of prior malignancy, the patient must be
disease free for at least 10 years.
6) Previous treatment with capecitabine, and/or lapatinib.
7) Patients with other concurrent severe and/or uncontrolled medical disease which could
compromise participation in the study, such as :
a) infection,
b) cardiac disease such as uncontrolled hypertension, congestive cardiac failure,
ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one
year, LVEF > grade 2,
c) current active hepatic or biliary disease (with exception of subjects with Gilbert's
syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per
investigator assessment),
d) renal disease,
e) active GI tract ulceration, malabsorption syndrome, disease significantly affecting
gastrointestinal function, or resection of the stomach or small bowel. Subjects with
active, uncontrolled ulcerative colitis are also excluded,
f) severely impaired lung function (spirometry and DLCO 50% or less of normal and O2
saturation of 88% or less at rest on room air).
8) Known dihydropyrimidine dehydrogenase (DPD) deficiency.
9) Patients being treated with drugs recognized as being strong inhibitors or inducers of the
isoenzyme CYP3A (Clarithromycin, Ketoconazole, Itroconazole, Voriconazole, Ritonavir, etc.)within the last 7 to 14 days prior to inclusion and/or during the study.
10) Pregnant women, women who are likely to become pregnant or are breast-feeding.
11) Patients with 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; those conditions should be
discussed with the patient before registration in the trial.
12) Patients who received any other investigational drugs within the 30 days prior to the
screening visit.
13) Individual deprived of liberty or placed under the authority of a tutor.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method