Trial Outcomes & Findings for A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer (NCT NCT02721641)
NCT ID: NCT02721641
Last Updated: 2017-03-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
69 participants
Primary outcome timeframe
From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
Results posted on
2017-03-31
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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69
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Overall Study
COMPLETED
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69
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was the only demographic variable collected for the study and was only collected from 32 participants.
Baseline characteristics by cohort
| Measure |
Herceptin
n=69 Participants
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.
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|---|---|
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Age, Continuous
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58.0 years
STANDARD_DEVIATION 11.00 • n=32 Participants • Age was the only demographic variable collected for the study and was only collected from 32 participants.
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PRIMARY outcome
Timeframe: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)Population: Analysis was performed on all enrolled participants.
Outcome measures
| Measure |
Herceptin
n=69 Participants
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.
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|---|---|
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On-Study Duration of Trial Treatment
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386.0 days
Interval 1.0 to 2697.0
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Herceptin
n=26 Participants
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.
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Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)
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0 Participants
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Herceptin
n=26 Participants
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.
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Number of Participants Withdrawn From Study Because of LVEF Dysfunction
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0 Participants
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Adverse Events
Herceptin
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Herceptin
n=69 participants at risk
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.
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|---|---|
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Infections and infestations
Arthritis bacterial
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1.4%
1/69 • 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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Infections and infestations
Erysipelas
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1.4%
1/69 • 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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Infections and infestations
Urinary tract infection
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1.4%
1/69 • 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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Gastrointestinal disorders
Nausea
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1.4%
1/69 • 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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Gastrointestinal disorders
Upper gastrointestinal haemorrhage
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1.4%
1/69 • 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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Gastrointestinal disorders
Vomiting
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1.4%
1/69 • 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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Injury, poisoning and procedural complications
Fibula fracture
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1.4%
1/69 • 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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Injury, poisoning and procedural complications
Lower limb fracture
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1.4%
1/69 • 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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General disorders
Pain
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1.4%
1/69 • 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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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
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1.4%
1/69 • 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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Nervous system disorders
Headache
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1.4%
1/69 • 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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Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
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1.4%
1/69 • 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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Surgical and medical procedures
Pain management
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1.4%
1/69 • 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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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER