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A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01363986
First received: May 31, 2011
Last updated: January 3, 2013
Last verified: January 2013
History of Changes

May 31, 2011
January 3, 2013
September 2011
September 2012   (final data collection date for primary outcome measure)
Brain response rate to trastuzumab and whole brain radiotherapy [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01363986 on ClinicalTrials.gov Archive Site
  • Brain response rate to trastuzumab and whole brain radiotherapy [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
  • Brain progression-free survival [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Patient's survival status [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer
A Multicenter, Open Label Study to Assess the Effect of Trastuzumab + Whole Brain Radiotherapy (WBRT) on Brain Metastases From HER-2 Positive Breast Cancer. (bHERt-2)

This single-arm, multicenter, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time on study treatment is 18 weeks.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: trastuzumab [Herceptin]
4 mg/kg (loading dose) followed by 2 mg/kg intravenously for a maximum number of 18 weekly cycles
Experimental: Single arm
Intervention: Drug: trastuzumab [Herceptin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of breast carcinoma with HER-2 overexpression
  • At least one measurable brain metastasis
  • Patients for whom, according to investigator assessment, whole brain radiotherapy is the best therapeutic option
  • Performance status (WHO) </=2
  • Life expectancy >/=3 months

Exclusion Criteria:

  • Presence of neoplastic meningitis
  • Any prior radiotherapy to the brain
  • Patients for whom, according to investigator assessment, stereotactic radiotherapy is the best therapeutic option
  • Previous neoplasms, other than breast carcinoma, within 5 years since enrolment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01363986
ML25432
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP