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

Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01363986
• Other study ID #: ML25432
• Status: Terminated
• Phase: Phase 2
• First received: May 31, 2011
• Last updated: July 23, 2014
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• trastuzumab [Herceptin]
Initial loading dose of 4 mg/kg i.v. infusion, followed by weekly doses of 2 mg/kg for up to 18 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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])	No
Secondary	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.	Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT)	No
Secondary	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.	BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment	No
Secondary	Overall Survival	The number of participants surviving at the final visit.	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	No
Secondary	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.	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	No