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

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ClinicalTrials.gov Identifier: NCT01363986
Recruitment Status : Terminated (Study was prematurely terminated due to difficulties experienced in recruiting patients in a reasonable timeframe.)
First Posted : June 2, 2011
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: trastuzumab [Herceptin] Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : September 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Trastuzumab Monotherapy
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.
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.




Primary Outcome Measures :
  1. Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7 [ Time Frame: 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 :
  1. Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15 [ Time Frame: 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.

  2. Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit [ 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 ]
    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.

  3. Overall Survival [ 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 ]
    The number of participants surviving at the final visit.

  4. Brain Progression-Free Survival (B-PFS) [ 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363986


Locations
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Italy
Ancona, Italy
Brindisi, Italy, 72100
Candiolo, Italy, 10060
Firenze, Italy, 50134
Latina, Italy, 04100
Lecce, Italy, 73100
Meldola, Italy, 47014
Parma, Italy, 43100
Ravenna, Italy, 48100
Roma, Italy, 00168
Rozzano, Italy, 20089
San Giovanni Rotondo, Italy, 71013
Saronno, Italy, 21047
Sassari, Italy, 07100
Torino, Italy, 10126
Viterbo, Italy, 01100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01363986     History of Changes
Other Study ID Numbers: ML25432
First Posted: June 2, 2011    Key Record Dates
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents