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 (HER2)-Positive Breast Cancer
CompletedPhase 3Results postedLast updated 27 April 2021
What this trial tests
Phase 3 trial testing Herceptin in Breast Neoplasms in 2,577 participants. Completed in 19 February 2020.
18 and older, any sex, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment PeriodPrimary· From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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.
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
88.6
Cohort B: SC Herceptin by SID
89.0
Percentage of Participants With a Grade 3 or Higher AE During the Treatment PeriodPrimary· From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
24.0
22.1 – 26.0
Cohort B: SC Herceptin by SID
21.0
18.1 – 24.2
Percentage of Participants With Treatment Interruption Due to an AEPrimary· From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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.
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
9.8
Cohort B: SC Herceptin by SID
10.4
Number of Herceptin Cycles ReceivedPrimary· From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self-Administered)
16.0
1 – 17
Cohort A: SC Herceptin by Needle/Syringe
18.0
1 – 19
Cohort B: SC Herceptin by SID
18.0
1 – 18
Percentage of Participants by Total Number of Herceptin Cycles ReceivedPrimary· From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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.
1 Cycle Received
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
2.7
Cohort A: SC Herceptin by Needle/Syringe
1.0
Cohort B: SC Herceptin by SID
0.8
2 Cycles Received
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
1.3
Cohort A: SC Herceptin by Needle/Syringe
0.5
Cohort B: SC Herceptin by SID
0.4
3 Cycles Received
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
1.1
Cohort A: SC Herceptin by Needle/Syringe
0.5
Cohort B: SC Herceptin by SID
0.1
4 Cycles Received
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
1.6
Cohort A: SC Herceptin by Needle/Syringe
1.2
Cohort B: SC Herceptin by SID
0.7
5 Cycles Received
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
1.3
Cohort A: SC Herceptin by Needle/Syringe
0.8
Cohort B: SC Herceptin by SID
0.6
6 Cycles Received
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
1.6
Cohort A: SC Herceptin by Needle/Syringe
0.5
Cohort B: SC Herceptin by SID
0.1
7 Cycles Received
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
2.2
Cohort A: SC Herceptin by Needle/Syringe
0.7
Cohort B: SC Herceptin by SID
0.8
8 Cycles Received
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
2.2
Cohort A: SC Herceptin by Needle/Syringe
0.9
Cohort B: SC Herceptin by SID
0.3
Percentage of Participants Who Received Concomitant Cancer TherapyPrimary· From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
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.
Chemotherapy
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
58.2
Cohort B: SC Herceptin by SID
63.9
Radiotherapy
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
51.3
Cohort B: SC Herceptin by SID
48.5
Hormone Therapy
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
53.5
Cohort B: SC Herceptin by SID
50.4
Percentage of Participants Who Received Concomitant Non-Cancer TherapyPrimary· From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
89.1
Cohort B: SC Herceptin by SID
89.7
Percentage of Participants Who Died by Data Cutoff of 10 March 2015Secondary· From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
The percentage of participants who died from any cause was reported.
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
1.5
Cohort B: SC Herceptin by SID
0.8
Percentage of Participants Who Died During the Safety Follow-up PeriodSecondary· From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)
The percentage of participants who died from any cause was reported during the safety follow-up period.
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
6.8
Cohort B: SC Herceptin by SID
7.3
Disease-Free Survival RateSecondary· From Baseline to time of event (up to approximately 8 years)
DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.
Time from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
0.5 Year
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.990
0.984 – 0.993
Cohort B: SC Herceptin by SID
0.987
0.976 – 0.993
1 Year
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.975
0.967 – 0.981
Cohort B: SC Herceptin by SID
0.976
0.961 – 0.985
1.5 Year
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.960
0.950 – 0.968
Cohort B: SC Herceptin by SID
0.957
0.939 – 0.970
2 Years
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.934
0.921 – 0.944
Cohort B: SC Herceptin by SID
0.939
0.918 – 0.955
3 Years
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.904
0.889 – 0.917
Cohort B: SC Herceptin by SID
0.896
0.870 – 0.916
4 Years
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.881
0.865 – 0.896
Cohort B: SC Herceptin by SID
0.874
0.847 – 0.897
5 Years
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.868
0.851 – 0.883
Cohort B: SC Herceptin by SID
0.863
0.835 – 0.887
6 Years
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.851
0.833 – 0.867
Cohort B: SC Herceptin by SID
0.853
0.824 – 0.878
Overall Survival RateSecondary· From Baseline to Time of Event (Up to Approximately 6 Years)
Overall survival was defined as the time from randomization to death from any cause.
Time from the date of randomization to the date of death was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
0.5 Year
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.999
0.996 – 1.000
Cohort B: SC Herceptin by SIDE
0.996
0.987 – 0.999
1 Year
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.998
0.994 – 0.999
Cohort B: SC Herceptin by SIDE
0.994
0.985 – 0.998
1.5 Year
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.993
0.988 – 0.996
Cohort B: SC Herceptin by SIDE
0.990
0.979 – 0.995
2 Years
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.985
0.979 – 0.990
Cohort B: SC Herceptin by SIDE
0.985
0.973 – 0.992
3 Years
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.968
0.958 – 0.975
Cohort B: SC Herceptin by SIDE
0.960
0.942 – 0.972
4 Years
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.947
0.935 – 0.956
Cohort B: SC Herceptin by SIDE
0.950
0.931 – 0.965
5 Years
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.937
0.925 – 0.948
Cohort B: SC Herceptin by SIDE
0.929
0.907 – 0.947
6 Years
Group
Value
95% CI
Cohort A: SC Herceptin by Needle/Syringe
0.927
0.913 – 0.938
Cohort B: SC Herceptin by SIDE
0.921
0.897 – 0.939
Percentage of Participants by Item Response to SID Satisfaction QuestionnaireSecondary· Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)
The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from "Strongly Disagree" to "Strongly Agree". Questionnaire items were as follows: "I felt comfortable injecting the study drug by myself" (Comfortable), "The SID was convenient and easy to use" (Easy to Use), "I am confident giving myself an injection in the thigh with the SID" (Confident), "Taking all things into account I find self-administration using the SID satisfactory" (Satisfactory), "If given the opportunity I would choose to continue se
Cycle 4: Comfortable, Strongly Disagree (n=514)
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
4.7
Cycle 4: Comfortable, Disagree (n=514)
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
2.3
Cycle 4: Comfortable, Unsure (n=514)
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
7.6
Cycle 4: Comfortable, Agree (n=514)
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
41.6
Cycle 4: Comfortable, Strongly Agree (n=514)
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
43.6
Cycle 4: Comfortable, Response Missing (n=514)
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
0.2
Cycle 4: Easy to Use, Strongly Disagree (n=514)
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
3.7
Cycle 4: Easy to Use, Disagree (n=514)
Group
Value
95% CI
Cohort B: SC Herceptin by SID (Self- Administered)
0.6
Adverse events — posted to ClinicalTrials.gov
Time frame: 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).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A: SC Herceptin by Needle/Syringe
Serious: 242/1864 (13%)
Deaths: —
Cohort B: SC Herceptin by SID
Serious: 84/709 (12%)
Deaths: —
Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up
Serious: 202/1862 (11%)
Deaths: —
Cohort B: SC Herceptin by SID Safety Follow-up
Serious: 53/707 (7%)
Deaths: —
Serious adverse events (345 terms)
Reaction
System
Cohort A: SC Herceptin by …
Cohort B: SC Herceptin by …
Cohort A: SC Herceptin by …
Cohort B: SC Herceptin by …
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03879577 — Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer
· Phase 2
· active not recruiting
NCT04905667 — Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®
· Phase 1
· completed
NCT03989037 — A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer
· Phase 3
· completed
NCT05301530 — Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Brea
· Phase 1
· completed
NCT03433313 — Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
· Phase 3
· completed
Other recruiting trials for Breast Neoplasms
Currently open trials in the same condition.
NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
· NA
· recruiting
NCT07500428 — Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models
· recruiting
NCT07581834 — Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multic
· Phase 2
· recruiting
NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
· Phase 2
· recruiting
NCT07465393 — Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors
· NA
· recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O
· Phase 2
· not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in
· Phase 3
· recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations
· not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
· Phase 3
· recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric
· Phase 3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 27 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01566721.