Trial Outcomes & Findings for A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment (NCT NCT01301729)
NCT ID: NCT01301729
Last Updated: 2016-12-29
Results Overview
PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
From the date of informed consent to the date of death or progressive disease (up to 28 months)
Results posted on
2016-12-29
Participant Flow
A total of 32 participants were enrolled in the study and received study treatment.
Participant milestones
| Measure |
Trastuzumab
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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|---|---|
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
Trastuzumab
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Overall Study
Participant did not Return for Treatment
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1
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Overall Study
Violated Selection Criteria
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1
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Baseline Characteristics
A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment
Baseline characteristics by cohort
| Measure |
Trastuzumab
n=32 Participants
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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Age, Continuous
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48.5 years
STANDARD_DEVIATION 11.61 • n=5 Participants
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Gender
Female
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32 Participants
n=5 Participants
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Gender
Male
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From the date of informed consent to the date of death or progressive disease (up to 28 months)Population: Intention to treat (ITT) data set is defined as all the participants who are eligible through screening, register and enter the study.
PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Trastuzumab
n=32 Participants
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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|---|---|
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Progression-Free Survival (PFS)
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9.9 months
Interval 6.28 to 13.63
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SECONDARY outcome
Timeframe: up to 28 monthsPopulation: ITT data set is defined as all the participants who are eligible through screening, register and enter the study.
Overall response rate was assessed using RECIST 1.0 and defined as the percentage of participants that achieved a complete response (CR) or a partial response (PR). CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.
Outcome measures
| Measure |
Trastuzumab
n=32 Participants
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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|---|---|
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Overall Response Rate
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81.3 percentage of participants
Interval 63.6 to 92.8
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SECONDARY outcome
Timeframe: From the time of PR or CR until the date of PD or death (up to 28 months)Population: ITT data set is defined as all the participants who are eligible through screening, register and enter the study. Here, number of participants are the participants who had response.
Duration of response was defined as the time from when a PR or CR was first documented until the date of documented PD or death. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. PD was defined as 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Trastuzumab
n=26 Participants
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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Duration of Response
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9.8 months
Interval 5.82 to 11.6
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SECONDARY outcome
Timeframe: Time from enrollment to the date of death (up to 28 months)Population: ITT data set is defined as all the participants who are eligible through screening, register and enter the study.
Overall survival was defined as the time from the date of enrollment to the date of death due to any cause.
Outcome measures
| Measure |
Trastuzumab
n=32 Participants
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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|---|---|
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Overall Survival
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NA months
Interval 22.64 to
The median for overall survival was not reached as insufficient number of participants had event.
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SECONDARY outcome
Timeframe: Up to 28 days after last infusion of the study drug (28 months)Population: Safety population is defined as all enrolled participants and have taken at least one dose of study drug.
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
Outcome measures
| Measure |
Trastuzumab
n=32 Participants
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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Percentage of Participants With an Adverse Event (AE)
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93.8 percentage of participants
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SECONDARY outcome
Timeframe: up to 28 monthsPopulation: Biomarker analysis was not performed as the eligible biomarker sample quantity was too limited for testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 28 monthsPopulation: ITT data set is defined as all the participants who are eligible through screening, register and enter the study.
Clinical benefit rate was assessed according to RECIST 1.0 and defined as the percentage of participants who experienced a CR, PR, or stable disease (SD) for at least 6 months. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.
Outcome measures
| Measure |
Trastuzumab
n=32 Participants
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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Clinical Benefit Rate
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81.3 percentage of participants
Interval 63.6 to 92.8
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SECONDARY outcome
Timeframe: From the date of enrollment until the date of progressive disease (up to 28 months)Population: ITT data set is defined as all the participants who are eligible through screening, register and enter the study.
Time to progression was defined as the time from the date of enrollment until the date of progressive disease.
Outcome measures
| Measure |
Trastuzumab
n=32 Participants
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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Time to Progression
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9.9 months
Interval 6.28 to 13.63
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Adverse Events
Trastuzumab
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trastuzumab
n=32 participants at risk
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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Infections and infestations
Infection
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3.1%
1/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Infections and infestations
Upper respiratory tract infection
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3.1%
1/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Psychiatric disorders
Completed suicide
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3.1%
1/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Blood and lymphatic system disorders
Leukopenia
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3.1%
1/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Blood and lymphatic system disorders
Neutropenia
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3.1%
1/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Eye disorders
Cataract
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3.1%
1/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Other adverse events
| Measure |
Trastuzumab
n=32 participants at risk
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
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|---|---|
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Investigations
Alanine aminotransferase increased
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12.5%
4/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Investigations
Aspartate aminotransferase increased
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9.4%
3/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Investigations
Transaminases increased
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6.2%
2/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Nervous system disorders
Hypoaesthesia
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34.4%
11/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Nervous system disorders
Headache
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9.4%
3/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Nervous system disorders
Insomnia
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6.2%
2/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Injury, poisoning and procedural complications
Neurotoxicity
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12.5%
4/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Musculoskeletal and connective tissue disorders
Musculoskeletal pain
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9.4%
3/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Respiratory, thoracic and mediastinal disorders
Cough
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12.5%
4/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Respiratory, thoracic and mediastinal disorders
Chest discomfort
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9.4%
3/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
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6.2%
2/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Skin and subcutaneous tissue disorders
Alopecia
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21.9%
7/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Skin and subcutaneous tissue disorders
Nail disorder
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15.6%
5/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Skin and subcutaneous tissue disorders
Rash
|
9.4%
3/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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Skin and subcutaneous tissue disorders
Pigmentation disorder
|
9.4%
3/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
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Skin and subcutaneous tissue disorders
Paronychia
|
6.2%
2/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
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General disorders
Asthenia
|
21.9%
7/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
General disorders
Pyrexia
|
18.8%
6/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
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General disorders
Oedema peripheral
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15.6%
5/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
General disorders
Flushing
|
6.2%
2/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
General disorders
Face oedema
|
6.2%
2/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
5/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Gastrointestinal disorders
Hypophagia
|
15.6%
5/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Gastrointestinal disorders
Vomting
|
12.5%
4/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.2%
2/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
59.4%
19/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
56.2%
18/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
31.2%
10/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
9.4%
3/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.4%
3/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
2/32 • Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
|
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