Study Stopped
Study was prematurely terminated due to difficulties experienced in recruiting patients in a reasonable timeframe.
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)
1 other identifier
interventional
3
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 breast-cancer
Started Sep 2011
Shorter than P25 for phase_2 breast-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
August 11, 2014
CompletedAugust 11, 2014
July 1, 2014
9 months
May 31, 2011
May 7, 2014
July 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7
Brain objective response was defined as either a complete response (CR) or partial response (PR), provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all central nervous system (CNS) lesions. PR was defined as a greater than or equal to (≥) 30 percent (%) reduction in the volumetric sum of all measurable CNS lesions.
Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])
Secondary Outcomes (4)
Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15
Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT)
Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit
BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment
Overall Survival
Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment
Brain Progression-Free Survival (B-PFS)
Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment
Study Arms (1)
Trastuzumab Monotherapy
EXPERIMENTALParticipants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.), followed by weekly doses of 2 mg/kg i.v. for up to 18 weeks.
Interventions
Initial loading dose of 4 mg/kg i.v. infusion, followed by weekly doses of 2 mg/kg for up to 18 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Ancona, Italy
Unknown Facility
Brindisi, 72100, Italy
Unknown Facility
Candiolo, 10060, Italy
Unknown Facility
Florence, 50134, Italy
Unknown Facility
Latina, 04100, Italy
Unknown Facility
Lecce, 73100, Italy
Unknown Facility
Meldola, 47014, Italy
Unknown Facility
Parma, 43100, Italy
Unknown Facility
Ravenna, 48100, Italy
Unknown Facility
Roma, 00168, Italy
Unknown Facility
Rozzano, 20089, Italy
Unknown Facility
San Giovanni Rotondo, 71013, Italy
Unknown Facility
Saronno, 21047, Italy
Unknown Facility
Sassari, 07100, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
Viterbo, 01100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2011
First Posted
June 2, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
August 11, 2014
Results First Posted
August 11, 2014
Record last verified: 2014-07