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Study was prematurely terminated due to difficulties experienced in recruiting patients in a reasonable timeframe.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab Monotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab [Herceptin] | Drug | Initial loading dose of 4 mg/kg i.v. infusion, followed by weekly doses of 2 mg/kg for up to 18 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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]) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ancona | Italy | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab Monotherapy | Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenously (i.v.) on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) |
| 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 |
| 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 |
| 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 |
| Brindisi |
| 72100 |
| Italy |
| Candiolo | 10060 | Italy |
| Florence | 50134 | Italy |
| Latina | 04100 | Italy |
| Lecce | 73100 | Italy |
| Meldola | 47014 | Italy |
| Parma | 43100 | Italy |
| Ravenna | 48100 | Italy |
| Roma | 00168 | Italy |
| Rozzano | 20089 | Italy |
| San Giovanni Rotondo | 71013 | Italy |
| Saronno | 21047 | Italy |
| Sassari | 07100 | Italy |
| Torino | 10126 | Italy |
| Viterbo | 01100 | Italy |
| COMPLETED |
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| NOT COMPLETED |
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Intent to treat (ITT) population included all consented participants who received study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab Monotherapy | Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT population; 1 participant was not assessed at Cycle 7. | Posted | Number | participants | Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT]) |
|
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| 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. | ITT population; 2 participants were not assessed at Cycle 15. | Posted | Number | participants | Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) |
|
| |||||||||||||||||||||||||||
| 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. | ITT population; 1 participant was not assessed at the final visit. | Posted | Number | participant | BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | The number of participants surviving at the final visit. | ITT population; survival status of 1 participant was unknown at the final visit. | Posted | Number | participant | 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 |
|
| |||||||||||||||||||||||||||
| 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. | Due to the premature interruption of the study and the small number of enrolled participants (3 nerolled), all participant data were listed only, without any descriptive statistics or data analysis. The endpoint of B-PFS was thus not analyzed. | Posted | 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 |
|
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Adverse events were reported from randomization up through 28 days after the final study drug treatment.
Safety was assessed in all consented participants who received study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trastuzumab Monotherapy | Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks. | 0 | 3 | 3 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | NCI-CTC AE 4.0 | Non-systematic Assessment |
| |
| Headache | General disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Device-related infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Gait disturbance | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Speech disorder | General disorders | MedDRA 14.1 | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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