Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2008-001084-10-FR
EUCTR2008-001084-10-FR
Active, not recruiting
Not Applicable

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

FNCLCC0 sitesOctober 21, 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
DrugsTyverb® 250mgXeloda® 150mgXeloda® 500mg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
FNCLCC
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 21, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FNCLCC

Eligibility Criteria

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •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 :

Outcomes

Primary Outcomes

Not specified

Similar Trials

Unknown
Phase 2
A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phaseChronic myelogenous leukemia
JPRN-UMIN000001927Tokyo STI Study Group50
Recruiting
Not Applicable
A multicentre two-arm, phase II trial assessing the safety and efficacy of first-line lazertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR-mutant non-small cell lung cancerNeoplasms
KCT0006760Yonsei University Health System, Severance Hospital68
Completed
Not Applicable
Phase II Multicenter Clinical Trial to evaluate the immune response generation capacity and the safety of the ALVAC-HIVVCP1452 Vaccine administered alone and in combination with the MN rpg 120 / HIV-1 vaccine in humans from Brazil, Haiti, Peru and Trinidad and Tobago.-B23 Human immunodeficiency virus [HIV] disease resulting in other conditionsHuman immunodeficiency virus [HIV] disease resulting in other conditionsB23
PER-036-01FRED HUTCHINSON CANCER RESEARCH CENTER,
Active, not recruiting
Phase 1
A clinical trial to evaluate the efficacy and safety ofpembrolizumab and gemcitabine in patients with HER2-negative Advanced Breast Cancer. PANGEA-Breast”Patients with HER2-negative advanced breast cancer.MedDRA version: 19.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-001779-54-ESGEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)36
Active, not recruiting
Phase 1
Clinical Trial to study the effect of the treatment with eribulin and endocrine therapy in metastatic breast cancer patientsuminal Metastatic Breast CancerMedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864MedDRA version: 20.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-004324-30-ESMedica Scientia Innovation Research (MEDSIR)60