Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGHerceptin
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ongoing participants from any completed global Roche-sponsored Herceptin trial * Participants enrolled in any Roche-sponsored Herceptin trial who have at least stable disease (or whose disease has not recurred) during Herceptin therapy at the end of the lead-in trial * Available study termination data (including tumor assessment and laboratory data) on the Case Report Form for the lead-in trial * Judged eligible by the investigator following a thorough risk/benefit assessment, if signs of chronic heart failure developed during the lead-in trial
Exclusion criteria
* Pregnant or nursing women * Women of childbearing potential unless using effective contraception as determined by the investigator * Severe dyspnea at rest requiring supplementary oxygen therapy * Severe uncontrolled systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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| Number of Participants Withdrawn From Study Because of LVEF Dysfunction | From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) | LVEF dysfunction was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. |
Countries
Australia, Belgium, China, France, Germany, Guatemala, Hungary, Israel, New Zealand, Panama, Poland, Portugal, Russia, Serbia, South Korea, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 69 |
| Total | 69 |
Baseline characteristics
| Characteristic | Herceptin | — |
|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 11 | — |
| Sex/Gender, Customized | — | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 11 / 69 |
Outcome results
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.
Time frame: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
Population: All enrolled participants with available LVEF data were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Herceptin | Number of Participants Withdrawn From Study Because of LVEF Dysfunction | 0 Participants |
Primary
Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)
Time frame: From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up)
Population: All enrolled participants with available LVEF data were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Herceptin | Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%) | 0 Participants |
Primary
On-Study Duration of Trial Treatment
Time frame: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
Population: Analysis was performed on all enrolled participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Herceptin | On-Study Duration of Trial Treatment | 386.0 days |