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Clinical Trials/EUCTR2010-021191-29-IT
EUCTR2010-021191-29-IT
Active, not recruiting
Not Applicable

A multicenter, open label study to assess the effect of trastuzumab + Whole Brain Radiotherapy (WBRT) on brain metastases from HER-2 positive breast cancer. - bHERt2

ROCHE0 sitesJune 13, 2011
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ConditionsStage IV, HER-2 positive breast cancer patients with brain metastasis and who are eligible for WBRT.MedDRA version: 13.1Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DrugsHerceptin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stage IV, HER-2 positive breast cancer patients with brain metastasis and who are eligible for WBRT.
Sponsor
ROCHE
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 13, 2011
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ROCHE

Eligibility Criteria

Inclusion Criteria

  • •1\. Written informed consent;
  • •2\. Patients aged \= 18 years;
  • •3\. Able to comply with the protocol procedures;
  • •4\. Patients with prior histological and/or cytological diagnosis of
  • •breast carcinoma with HER\-2 over expression (IHC 3\+; IHC 2\+
  • •and amplified FISH or CISH or SISH) who have first evidence of
  • •disease progression to the brain, regardless of control of
  • •extracranial disease if present;
  • •5\. At least one measurable brain metastasis evaluated with brain
  • •contrast MRI;

Exclusion Criteria

  • •1\. Presence of neoplastic meningitis;
  • •2\. Any prior radiotherapy to the brain;
  • •3\. Patients with non\-controlled extra\-cerebral disease who at the
  • •time of enrolment, according to investigator judgment, are
  • •eligible to a chemotherapy treatment not compatible with the
  • •study protocol related timelines;
  • •4\. Patients for whom, according to investigator assessment,
  • •stereotactic radiotherapy is the best therapeutic option;
  • •5\. Previous neoplasm, other than breast carcinoma, within 5 years
  • •since the enrolment. Patients with previous diagnosis of in situ

Outcomes

Primary Outcomes

Not specified

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