Back to resultsA Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
trastuzumab [Herceptin]
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trastuzumab Monotherapy
Arm Description
Participants 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15
Brain objective response was defined as either a CR or 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 CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.
Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit
Brain objective response was defined as either a CR or 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 CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.
Overall Survival
The number of participants surviving at the final visit.
Brain Progression-Free Survival (B-PFS)
B-PFS was defined as the time from the date of first study drug assumption and the date of documented evidence of brain progression (defined as appearance of new brain metastases or progression of pre-existing lesions) or death for brain progression, whichever came first. Progression in other metastatic sites, deaths not due to brain-progression and withdrawals due to adverse events were to be considered as competing risk.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01363986
Brief Title
A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Study was prematurely terminated due to difficulties experienced in recruiting patients in a reasonable timeframe.
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trastuzumab Monotherapy
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
trastuzumab [Herceptin]
Intervention Description
Initial loading dose of 4 mg/kg i.v. infusion, followed by weekly doses of 2 mg/kg for up to 18 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7
Description
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.
Time Frame
Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])
Secondary Outcome Measure Information:
Title
Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15
Description
Brain objective response was defined as either a CR or 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 CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.
Time Frame
Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT)
Title
Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit
Description
Brain objective response was defined as either a CR or 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 CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.
Time Frame
BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment
Title
Overall Survival
Description
The number of participants surviving at the final visit.
Time Frame
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
Title
Brain Progression-Free Survival (B-PFS)
Description
B-PFS was defined as the time from the date of first study drug assumption and the date of documented evidence of brain progression (defined as appearance of new brain metastases or progression of pre-existing lesions) or death for brain progression, whichever came first. Progression in other metastatic sites, deaths not due to brain-progression and withdrawals due to adverse events were to be considered as competing risk.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Ancona
Country
Italy
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
City
Firenze
ZIP/Postal Code
50134
Country
Italy
City
Latina
ZIP/Postal Code
04100
Country
Italy
City
Lecce
ZIP/Postal Code
73100
Country
Italy
City
Meldola
ZIP/Postal Code
47014
Country
Italy
City
Parma
ZIP/Postal Code
43100
Country
Italy
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
City
Saronno
ZIP/Postal Code
21047
Country
Italy
City
Sassari
ZIP/Postal Code
07100
Country
Italy
City
Torino
ZIP/Postal Code
10126
Country
Italy
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer
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