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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01363986

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: trastuzumab [Herceptin]	Phase 2

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Brain response rate to trastuzumab and whole brain radiotherapy [ Time Frame: Week 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	66
Study Start Date:	September 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single arm	Drug: trastuzumab [Herceptin] 4 mg/kg (loading dose) followed by 2 mg/kg intravenously for a maximum number of 18 weekly cycles

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363986

Contacts

Contact: Please reference Study ID Number: ML25432

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

Italy
	Not yet recruiting
Ancona, Italy
	Terminated
Brindisi, Italy, 72100
	Terminated
Candiolo, Italy, 10060
	Not yet recruiting
Catania, Italy, 95100
	Terminated
Firenze, Italy, 50134
	Terminated
Latina, Italy, 04100
	Not yet recruiting
Latina, Italy, 04100
	Not yet recruiting
Lecce, Italy, 73100
	Not yet recruiting
Macerata, Italy, 62100
	Completed
Meldola, Italy, 47014
	Completed
Parma, Italy, 43100
	Completed
Ravenna, Italy, 48100
	Recruiting
Roma, Italy, 00158
	Not yet recruiting
Rozzano, Italy, 20089
	Terminated
San Giovanni Rotondo, Italy, 71013
	Terminated
Saronno, Italy, 21047
	Terminated
Sassari, Italy, 07100
	Recruiting
Torino, Italy, 10126
	Terminated
Viterbo, Italy, 01100

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01363986 History of Changes
Other Study ID Numbers:	ML25432
Study First Received:	May 31, 2011
Last Updated:	May 21, 2012
Health Authority:	Italy: Ministry of Health

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012