TriangleNCT01566721 · STUDY IN CONTEXT
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (H
Draft scope assessment: unclear. Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.
Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.
Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- trial label
- A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (H
- applicability
- unclear
- applicability note
- Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0000
- source section id
- NCT01566721-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
- endpoint definition
- Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.
- time origin
- From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0001
- source section id
- NCT01566721-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
- endpoint definition
- Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.
- time origin
- From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0002
- source section id
- NCT01566721-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants With Treatment Interruption Due to an AE
- endpoint definition
- Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.
- time origin
- From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0003
- source section id
- NCT01566721-om-0003
- source outcome index
- 3
- endpoint
- Number of Herceptin Cycles Received
- endpoint definition
- Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
- time origin
- From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0004
- source section id
- NCT01566721-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants by Total Number of Herceptin Cycles Received
- endpoint definition
- Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.
- time origin
- From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0005
- source section id
- NCT01566721-om-0005
- source outcome index
- 5
- endpoint
- Percentage of Participants Who Received Concomitant Cancer Therapy
- endpoint definition
- Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.
- time origin
- From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cohort A: SC Herceptin by Needle/Syringe
- regimen
- Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
- analyzed count
- 1864
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cohort B: SC Herceptin by SID
- regimen
- Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
- analyzed count
- 709
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Cohort A: SC Herceptin by Needle/Syringe
- regimen
- Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
- analyzed count
- 1864
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cohort B: SC Herceptin by SID
- regimen
- Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
- analyzed count
- 709
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Cohort A: SC Herceptin by Needle/Syringe
- regimen
- Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
- analyzed count
- 1864
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Cohort B: SC Herceptin by SID
- regimen
- Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
- analyzed count
- 709
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Cohort B: SC Herceptin by SID (Self-Administered)
- regimen
- Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
- analyzed count
- 550
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Cohort A: SC Herceptin by Needle/Syringe
- regimen
- Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
- analyzed count
- 1864
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Cohort B: SC Herceptin by SID
- regimen
- Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
- analyzed count
- 709
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Cohort B: SC Herceptin by SID (Self- Administered)
- regimen
- Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self- administration.
- analyzed count
- 550
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Cohort A: SC Herceptin by Needle/Syringe
- regimen
- Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
- analyzed count
- 1864
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- outcome key
- om-0004
- arm key
- OG002
- arm label
- Cohort B: SC Herceptin by SID
- regimen
- Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
- analyzed count
- 709
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01566721-om-0004#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- harm key
- EG000
- source section id
- NCT01566721-ae
- event group key
- EG000
- event group label
- Cohort A: SC Herceptin by Needle/Syringe
- serious affected
- 242
- serious at risk
- 1864
- other affected
- 1499
- other at risk
- 1864
- frequency threshold
- 5
- collection period
- Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
- event definition
- Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- harm key
- EG001
- source section id
- NCT01566721-ae
- event group key
- EG001
- event group label
- Cohort B: SC Herceptin by SID
- serious affected
- 84
- serious at risk
- 709
- other affected
- 576
- other at risk
- 709
- frequency threshold
- 5
- collection period
- Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
- event definition
- Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- harm key
- EG002
- source section id
- NCT01566721-ae
- event group key
- EG002
- event group label
- Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up
- serious affected
- 202
- serious at risk
- 1862
- other affected
- 0
- other at risk
- 1862
- frequency threshold
- 5
- collection period
- Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
- event definition
- Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT01566721
- harm key
- EG003
- source section id
- NCT01566721-ae
- event group key
- EG003
- event group label
- Cohort B: SC Herceptin by SID Safety Follow-up
- serious affected
- 53
- serious at risk
- 707
- other affected
- 0
- other at risk
- 707
- frequency threshold
- 5
- collection period
- Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
- event definition
- Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice