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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000348-28 | EudraCT Number |
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This study is designed to provide continued access to intravenous (IV) Herceptin and to evaluate long-term outcomes and overall safety in participants with stable disease and human epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who have completed a prior study with IV Herceptin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Herceptin | Experimental | Participants with stable disease and HER2-overexpressing metastatic or locally advanced cancer will receive expanded access to IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herceptin | Drug | Herceptin will be administered as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| On-Study Duration of Trial Treatment | From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) | |
| Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%) | From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up) | |
| Number of Participants Withdrawn From Study Because of LVEF Dysfunction | LVEF dysfunction was defined as low LVEF measured on two consecutive assessments, with the second assessment performed after 3 weeks of study medication being withheld. Low LVEF included values less than or equal to 39% or values between 40% and 45% (inclusive) with a decrease of 10 or more percentage points from Baseline. | From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool | New South Wales | 2170 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29544445 | Derived | Muller V, Clemens M, Jassem J, Al-Sakaff N, Auclair P, Nuesch E, Holloway D, Shing M, Bang YJ. Long-term trastuzumab (Herceptin(R)) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer. BMC Cancer. 2018 Mar 15;18(1):295. doi: 10.1186/s12885-018-4183-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Herceptin | Participants received intravenous (IV) Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Waratah |
| New South Wales |
| 2298 |
| Australia |
| Brisbane | Queensland | 4006 | Australia |
| Brisbane | Queensland | 4066 | Australia |
| Fitzroy | Victoria | 3065 | Australia |
| Geelong | Victoria | 3220 | Australia |
| Parkville | Victoria | 3052 | Australia |
| Brussels | 1090 | Belgium |
| Beijing | 100021 | China |
| Beijing | 100142 | China |
| Marseille | 13273 | France |
| Berlin | 12203 | Germany |
| Göttingen | 37075 | Germany |
| Hamburg | 20246 | Germany |
| Heidelberg | 69120 | Germany |
| Lübeck | 23538 | Germany |
| München | 80637 | Germany |
| München | 81377 | Germany |
| Trier | 54290 | Germany |
| Guatemala City | 01010 | Guatemala |
| Budapest | 1122 | Hungary |
| Debrecen | 4032 | Hungary |
| Ramat Gan | 5262100 | Israel |
| Auckland | 1023 | New Zealand |
| Panama City | 0832-00752 | Panama |
| Gdansk | 80-214 | Poland |
| Lisbon | 1099-023 | Portugal |
| Izhevsk | 426009 | Russia |
| Moscow | 115478 | Russia |
| Saint Petersburg | 197758 | Russia |
| Belgrade | 11000 | Serbia |
| Bundang City | 463-802 | South Korea |
| Seoul | 03080 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 138-736 | South Korea |
| Alicante | Alicante | 3010 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Edinburgh | EH4 2XU | United Kingdom |
| Glasgow | G12 0YN | United Kingdom |
| London | SE1 9RT | United Kingdom |
| Nottingham | NG5 1PB | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Age was the only demographic variable collected for the study and was only collected from 32 participants. Gender, weight, and race were not collected under the protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Herceptin | Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was the only demographic variable collected for the study and was only collected from 32 participants. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex/Gender, Customized | Gender information was not collected under the protocol. | Number | 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 | On-Study Duration of Trial Treatment | Analysis was performed on all enrolled participants. | Posted | Median | Full Range | days | From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) |
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| Primary | Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%) | All enrolled participants with available LVEF data were included in the analysis. | Posted | Count of Participants | Participants | From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up) |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants Withdrawn From Study Because of LVEF Dysfunction | LVEF dysfunction was defined as low LVEF measured on two consecutive assessments, with the second assessment performed after 3 weeks of study medication being withheld. Low LVEF included values less than or equal to 39% or values between 40% and 45% (inclusive) with a decrease of 10 or more percentage points from Baseline. | All enrolled participants with available LVEF data were included in the analysis. | Posted | Count of Participants | Participants | From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) |
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From date of enrollment until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment (up to approximately 7.4 years)
Only serious adverse events were collected during the trial. Terms were reported verbatim as provided by the reporter and were not re-coded. Analysis was performed on all enrolled participants.
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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 | Herceptin | Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes. | 11 | 69 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis bacterial | Infections and infestations | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pain | General disorders | Non-systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pain management | Surgical and medical procedures | 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 | Hoffmann-La Roche | 800-821-8590 | global-roche-genentech-trials@gene.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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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