Trial · NCT01566721
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
NCT01566721, Phase 3, Completed, Hoffmann-La Roche; results first posted 2017-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01566721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01566721
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT01566721
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,577 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Breast Neoplasms
- Interventions
- Herceptin
- First posted
- 2012-03-29
- Last updated
- 2021-04-27
- Other registries' IDs
- eudract:2011-005328-17
- Results first posted
- 2017-04-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period | 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. |
| Primary | Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period | 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 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. |
| Primary | Percentage of Participants With Treatment Interruption Due to an AE | 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. |
| Primary | Number of Herceptin Cycles Received | 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. |
| Primary | Percentage of Participants by Total Number of Herceptin Cycles Received | 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. |
| Primary | Percentage of Participants Who Received Concomitant Cancer Therapy | 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. |
| Primary | Percentage of Participants Who Received Concomitant Non-Cancer Therapy | 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. |
| Secondary | Percentage of Participants Who Died by Data Cutoff of 10 March 2015 | 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. |
| Secondary | Percentage of Participants Who Died During the Safety Follow-up Period | 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. |
| Secondary | Disease-Free Survival Rate | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment Interruption Due to an AE | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Number of Herceptin Cycles Received | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | 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. | cycles | MEDIAN |
| PRIMARY | Percentage of Participants by Total Number of Herceptin Cycles Received | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | 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. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Received Concomitant Cancer Therapy | From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years) | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Received Concomitant Non-Cancer Therapy | From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years) | Safety Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died by Data Cutoff of 10 March 2015 | From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015) | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died During the Safety Follow-up Period | From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years) | ITT Population | Percentage of Participants | NUMBER |
| SECONDARY | Disease-Free Survival Rate | From Baseline to time of event (up to approximately 8 years) | ITT Population who completed Safety Follow-up | Kaplan-Meier survival probability | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group170
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period | Cohort A: SC Herceptin by Needle/Syringe | 88.6 | percentage of participants | ||
| Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period | Cohort B: SC Herceptin by SID | 89.0 | percentage of participants | ||
| Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period | Cohort A: SC Herceptin by Needle/Syringe | 24.0 | 95% Confidence Interval 22.1 to 26.0 | percentage of participants | |
| Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period | Cohort B: SC Herceptin by SID | 21.0 | 95% Confidence Interval 18.1 to 24.2 | percentage of participants | |
| Percentage of Participants With Treatment Interruption Due to an AE | Cohort A: SC Herceptin by Needle/Syringe | 9.8 | percentage of participants | ||
| Percentage of Participants With Treatment Interruption Due to an AE | Cohort B: SC Herceptin by SID | 10.4 | percentage of participants | ||
| Number of Herceptin Cycles Received | Cohort B: SC Herceptin by SID (Self-Administered) | 16.0 | Full Range 1 to 17 | cycles | |
| Number of Herceptin Cycles Received | Cohort A: SC Herceptin by Needle/Syringe | 18.0 | Full Range 1 to 19 | cycles | |
| Number of Herceptin Cycles Received | Cohort B: SC Herceptin by SID | 18.0 | Full Range 1 to 18 | cycles | |
| Percentage of Participants by Total Number of Herceptin Cycles Received | Cohort B: SC Herceptin by SID (Self- Administered) | 1 Cycle Received | 2.7 | percentage of participants |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Cohort A: SC Herceptin by Needle/Syringe | 1,867 | |
| Treatment Period | STARTED | Cohort B: SC Herceptin by Single-Use Injection Device (SID) | 710 | |
| Treatment Period | COMPLETED | Cohort A: SC Herceptin by Needle/Syringe | 1,670 | |
| Treatment Period | COMPLETED | Cohort B: SC Herceptin by Single-Use Injection Device (SID) | 652 | |
| Treatment Period | NOT COMPLETED | Cohort A: SC Herceptin by Needle/Syringe | 197 | |
| Treatment Period | NOT COMPLETED | Cohort B: SC Herceptin by Single-Use Injection Device (SID) | 58 | |
| Safety Follow-up | STARTED | Cohort A: SC Herceptin by Needle/Syringe | 1,865 | |
| Safety Follow-up | STARTED | Cohort B: SC Herceptin by Single-Use Injection Device (SID) | 708 | |
| Safety Follow-up | COMPLETED | Cohort A: SC Herceptin by Needle/Syringe | 1,318 | |
| Safety Follow-up | COMPLETED | Cohort B: SC Herceptin by Single-Use Injection Device (SID) | 501 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,556
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Cohort A: SC Herceptin by Needle/Syringe | 381 | 1,864 | |
| other | Fatigue | General disorders | Cohort B: SC Herceptin by SID | 132 | 709 | |
| other | Fatigue | General disorders | Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up | 0 | 1,862 | |
| other | Fatigue | General disorders | Cohort B: SC Herceptin by SID Safety Follow-up | 0 | 707 | |
| other | Asthenia | General disorders | Cohort A: SC Herceptin by Needle/Syringe | 221 | 1,864 | |
| other | Asthenia | General disorders | Cohort B: SC Herceptin by SID | 85 | 709 | |
| other | Asthenia | General disorders | Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up | 0 | 1,862 | |
| other | Asthenia | General disorders | Cohort B: SC Herceptin by SID Safety Follow-up | 0 | 707 | |
| other | Pyrexia | General disorders | Cohort A: SC Herceptin by Needle/Syringe | 185 | 1,864 | |
| other | Pyrexia | General disorders | Cohort B: SC Herceptin by SID | 55 | 709 |
1 to 10 of 1,556Source ClinicalTrials.gov
See all 1,556 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: SC Herceptin by Needle/Syringe | ||
| Total, all-cause mortality | Cohort B: SC Herceptin by SID | ||
| Total, all-cause mortality | Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up | ||
| Total, all-cause mortality | Cohort B: SC Herceptin by SID Safety Follow-up | ||
| Total, other adverse events | Cohort A: SC Herceptin by Needle/Syringe | 1,499 | 1,864 |
| Total, other adverse events | Cohort B: SC Herceptin by SID | 576 | 709 |
| Total, other adverse events | Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up | 0 | 1,862 |
| Total, other adverse events | Cohort B: SC Herceptin by SID Safety Follow-up | 0 | 707 |
| Total, serious adverse events | Cohort A: SC Herceptin by Needle/Syringe | 242 | 1,864 |
| Total, serious adverse events | Cohort B: SC Herceptin by SID | 84 | 709 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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