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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: trastuzumab [Herceptin]

• Registration Number: NCT01363986
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Study Start: 2011-09
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2014-05-07
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-23
• Last Update Submitted: 2014-07-23
• Results First Posted: 2014-08-11
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trastuzumab Monotherapy	trastuzumab [Herceptin]	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7	Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])	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

Name	Time	Method
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	The number of participants surviving at the final visit.
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)	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.
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	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.
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	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.