A Phase 3 interventional study of Herceptin in Breast Neoplasms, sponsored by Hoffmann-La Roche. Completed at 437 sites in 59 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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).
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 2,577 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive SC Herceptin by an assisted administration using a conventional syringe and needle/vial formulation.
Drug: Herceptin
Participants will receive SC Herceptin with assisted and/or self-administered use of an SID. The first administration will be performed by a trained healthcare professional. If well tolerated and the participant is willing and judged competent to perform self-administration, subsequent administration of SC Herceptin may be performed by the participant.
Drug: Herceptin
Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
Also known as: Trastuzumab
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
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 frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
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 frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants With Treatment Interruption Due to an AE
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 frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Number of Herceptin Cycles Received
Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
Time frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants by Total Number of Herceptin Cycles Received
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 frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants Who Received Concomitant Cancer Therapy
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 frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Percentage of Participants Who Received Concomitant Non-Cancer Therapy
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.
Time frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Percentage of Participants Who Died by Data Cutoff of 10 March 2015
The percentage of participants who died from any cause was reported.
Time frame: From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
Percentage of Participants Who Died During the Safety Follow-up Period
The percentage of participants who died from any cause was reported during the safety follow-up period.
Time frame: From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)
Disease-Free Survival Rate
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.
Time frame: From Baseline to time of event (up to approximately 8 years)
Overall Survival Rate
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.
Time frame: From Baseline to Time of Event (Up to Approximately 6 Years)
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
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 self-injecting the study drug using the SID in the future" (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire.
Time frame: Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)
| Milestone | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by Single-Use Injection Device (SID) |
|---|---|---|
| Started | 1867 | 710 |
| Completed | 1670 | 652 |
| Not completed | 197 | 58 |
| Withdrew: Withdrawal by subject | 35 | 9 |
| Withdrew: Disease progression/recurrence | 37 | 13 |
| Withdrew: Investigator/sponsor decision | 6 | 3 |
| Withdrew: Other | 13 | 2 |
| Withdrew: Lack of compliance | 5 | 1 |
| Withdrew: Adverse event | 100 | 30 |
| Withdrew: Pregnancy | 1 | 0 |
| Milestone | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by Single-Use Injection Device (SID) |
|---|---|---|
| Started | 1865 | 708 |
| Completed | 1318 | 501 |
| Not completed | 547 | 207 |
| Withdrew: Physician decision | 6 | 4 |
| Withdrew: Lost to follow-up | 101 | 48 |
| Withdrew: Withdrawal by subject | 155 | 49 |
| Withdrew: Death | 28 | 4 |
| Withdrew: Non-compliance | 7 | 3 |
| Withdrew: Protocol violation | 7 | 0 |
| Withdrew: Site closure | 2 | 3 |
| Withdrew: Erroneous reporting or late reporting | 2 | 0 |
| Withdrew: Missing | 7 | 2 |
| Withdrew: Disease progression /disease recurrence | 223 | 90 |
| Withdrew: Sponsor decision | 1 | 0 |
| Withdrew: Adverse event | 8 | 4 |
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.
| percentage of participants | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID |
|---|---|---|
| Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period | 88.6 | 89.0 |
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.
| percentage of participants | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID |
|---|---|---|
| Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period | 24.0 (22.1 to 26.0) | 21.0 (18.1 to 24.2) |
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.
| percentage of participants | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID |
|---|---|---|
| Percentage of Participants With Treatment Interruption Due to an AE | 9.8 | 10.4 |
Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
| cycles | Cohort B: SC Herceptin by SID (Self-Administered) | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID |
|---|---|---|---|
| Number of Herceptin Cycles Received | 16.0 (1 to 17) | 18.0 (1 to 19) | 18.0 (1 to 18) |
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.
| percentage of participants | Cohort B: SC Herceptin by SID (Self- Administered) | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID |
|---|---|---|---|
| 1 Cycle Received | 2.7 | 1.0 | 0.8 |
| 2 Cycles Received | 1.3 | 0.5 | 0.4 |
| 3 Cycles Received | 1.1 | 0.5 | 0.1 |
| 4 Cycles Received | 1.6 | 1.2 | 0.7 |
| 5 Cycles Received | 1.3 | 0.8 | 0.6 |
| 6 Cycles Received | 1.6 | 0.5 | 0.1 |
| 7 Cycles Received | 2.2 | 0.7 | 0.8 |
| 8 Cycles Received | 2.2 | 0.9 | 0.3 |
| 9 Cycles Received | 1.8 | 0.2 | 0.6 |
| 10 Cycles Received | 1.5 | 0.3 | 0.1 |
| 11 Cycles Received | 3.5 | 0.4 | 0.3 |
| 12 Cycles Received | 2.5 | 0.9 | 0.8 |
| 13 Cycles Received | 4.9 | 0.2 | 0 |
| 14 Cycles Received | 6.9 | 0.5 | 0.6 |
| 15 Cycles Received | 10.7 | 0.5 | 0.4 |
| 16 Cycles Received | 21.6 | 0.6 | 0.3 |
| 17 Cycles Received | 32.5 | 1.0 | 1.1 |
| 18 Cycles Received | 0 | 89.2 | 91.8 |
| 19 Cycles Received | 0 | 0.2 | 0 |
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.
| percentage of participants | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID |
|---|---|---|
| Chemotherapy | 58.2 | 63.9 |
| Radiotherapy | 51.3 | 48.5 |
| Hormone Therapy | 53.5 | 50.4 |
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.
| percentage of participants | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID |
|---|---|---|
| Percentage of Participants Who Received Concomitant Non-Cancer Therapy | 89.1 | 89.7 |
The percentage of participants who died from any cause was reported.
| percentage of participants | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID |
|---|---|---|
| Percentage of Participants Who Died by Data Cutoff of 10 March 2015 | 1.5 | 0.8 |
The percentage of participants who died from any cause was reported during the safety follow-up period.
| Percentage of Participants | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID |
|---|---|---|
| Percentage of Participants Who Died During the Safety Follow-up Period | 6.8 | 7.3 |
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.
| Kaplan-Meier survival probability | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID |
|---|---|---|
| 0.5 Year | 0.990 (0.984 to 0.993) | 0.987 (0.976 to 0.993) |
| 1 Year | 0.975 (0.967 to 0.981) | 0.976 (0.961 to 0.985) |
| 1.5 Year | 0.960 (0.950 to 0.968) | 0.957 (0.939 to 0.970) |
| 2 Years | 0.934 (0.921 to 0.944) | 0.939 (0.918 to 0.955) |
| 3 Years | 0.904 (0.889 to 0.917) | 0.896 (0.870 to 0.916) |
| 4 Years | 0.881 (0.865 to 0.896) | 0.874 (0.847 to 0.897) |
| 5 Years | 0.868 (0.851 to 0.883) | 0.863 (0.835 to 0.887) |
| 6 Years | 0.851 (0.833 to 0.867) | 0.853 (0.824 to 0.878) |
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.
| Kaplan-Meier survival probability | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SIDE |
|---|---|---|
| 0.5 Year | 0.999 (0.996 to 1.000) | 0.996 (0.987 to 0.999) |
| 1 Year | 0.998 (0.994 to 0.999) | 0.994 (0.985 to 0.998) |
| 1.5 Year | 0.993 (0.988 to 0.996) | 0.990 (0.979 to 0.995) |
| 2 Years | 0.985 (0.979 to 0.990) | 0.985 (0.973 to 0.992) |
| 3 Years | 0.968 (0.958 to 0.975) | 0.960 (0.942 to 0.972) |
| 4 Years | 0.947 (0.935 to 0.956) | 0.950 (0.931 to 0.965) |
| 5 Years | 0.937 (0.925 to 0.948) | 0.929 (0.907 to 0.947) |
| 6 Years | 0.927 (0.913 to 0.938) | 0.921 (0.897 to 0.939) |
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 self-injecting the study drug using the SID in the future" (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire.
| percentage of participants | Cohort B: SC Herceptin by SID (Self- Administered) |
|---|---|
| Cycle 4: Comfortable, Strongly Disagree (n=514) | 4.7 |
| Cycle 4: Comfortable, Disagree (n=514) | 2.3 |
| Cycle 4: Comfortable, Unsure (n=514) | 7.6 |
| Cycle 4: Comfortable, Agree (n=514) | 41.6 |
| Cycle 4: Comfortable, Strongly Agree (n=514) | 43.6 |
| Cycle 4: Comfortable, Response Missing (n=514) | 0.2 |
| Cycle 4: Easy to Use, Strongly Disagree (n=514) | 3.7 |
| Cycle 4: Easy to Use, Disagree (n=514) | 0.6 |
| Cycle 4: Easy to Use, Unsure (n=514) | 1.8 |
| Cycle 4: Easy to Use, Agree (n=514) | 37.7 |
| Cycle 4: Easy to Use, Strongly Agree (n=514) | 56.0 |
| Cycle 4: Easy to Use, Response Missing (n=514) | 0.2 |
| Cycle 4: Confident, Strongly Disagree (n=514) | 3.9 |
| Cycle 4: Confident, Disagree (n=514) | 0.8 |
| Cycle 4: Confident, Unsure (n=514) | 7.2 |
| Cycle 4: Confident, Agree (n=514) | 42.8 |
| Cycle 4: Confident, Strongly Agree (n=514) | 45.1 |
| Cycle 4: Confident, Response Missing (n=514) | 0.2 |
| Cycle 4: Satisfactory, Strongly Disagree (n=514) | 3.9 |
| Cycle 4: Satisfactory, Disagree (n=514) | 0.6 |
| Cycle 4: Satisfactory, Unsure (n=514) | 2.7 |
| Cycle 4: Satisfactory, Agree (n=514) | 38.7 |
| Cycle 4: Satisfactory, Strongly Agree (n=514) | 53.9 |
| Cycle 4: Satisfactory, Response Missing (n=514) | 0.2 |
| Cycle 4: Continue, Strongly Disagree (n=514) | 3.9 |
| Cycle 4: Continue, Disagree (n=514) | 1.4 |
| Cycle 4: Continue, Unsure (n=514) | 5.3 |
| Cycle 4: Continue, Agree (n=514) | 33.5 |
| Cycle 4: Continue, Strongly Agree (n=514) | 55.8 |
| Cycle 4: Continue, Response Missing (n=514) | 0.2 |
| LSFU: Comfortable, Strongly Disagree (n=415) | 3.6 |
| LSFU: Comfortable, Disagree (n=415) | 3.1 |
| LSFU: Comfortable, Unsure (n=415) | 5.3 |
| LSFU: Comfortable, Agree (n=415) | 35.9 |
| LSFU: Comfortable, Strongly Agree (n=415) | 51.8 |
| LSFU: Comfortable, Response Missing (n=415) | 0.2 |
| LSFU: Easy to Use, Strongly Disagree (n=415) | 3.9 |
| LSFU: Easy to Use, Disagree (n=415) | 1.0 |
| LSFU: Easy to Use, Unsure (n=415) | 1.7 |
| LSFU: Easy to Use, Agree (n=415) | 34.9 |
| LSFU: Easy to Use, Strongly Agree (n=415) | 58.6 |
| LSFU: Easy to Use, Response Missing (n=415) | 0 |
| LSFU: Confident, Strongly Disagree (n=415) | 4.6 |
| LSFU: Confident, Disagree (n=415) | 1.2 |
| LSFU: Confident, Unsure (n=415) | 4.3 |
| LSFU: Confident, Agree (n=415) | 33.3 |
| LSFU: Confident, Strongly Agree (n=415) | 56.6 |
| LSFU: Confident, Response Missing (n=415) | 0 |
| LSFU: Satisfactory, Strongly Disagree (n=415) | 4.3 |
| LSFU: Satisfactory, Disagree (n=415) | 1.2 |
| LSFU: Satisfactory, Unsure (n=415) | 2.2 |
| LSFU: Satisfactory, Agree (n=415) | 30.8 |
| LSFU: Satisfactory, Strongly Agree (n=415) | 61.2 |
| LSFU: Satisfactory, Response Missing (n=415) | 0.2 |
| LSFU: Continue, Strongly Disagree (n=415) | 4.6 |
| LSFU: Continue, Disagree (n=415) | 1.2 |
| LSFU: Continue, Unsure (n=415) | 2.9 |
| LSFU: Continue, Agree (n=415) | 28.2 |
| LSFU: Continue, Strongly Agree (n=415) | 63.1 |
| LSFU: Continue, Response Missing (n=415) | 0 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A: SC Herceptin by Needle/Syringe | — | 242/1,864 (13%) | 1,499/1,864 (80.4%) |
| Cohort B: SC Herceptin by SID | — | 84/709 (11.8%) | 576/709 (81.2%) |
| Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up | — | 202/1,862 (10.8%) | 0/1,862 (0%) |
| Cohort B: SC Herceptin by SID Safety Follow-up | — | 53/707 (7.5%) | 0/707 (0%) |
| Event | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID | Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up | Cohort B: SC Herceptin by SID Safety Follow-up |
|---|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 39/1864 | 14/709 | 1/1862 | 0/707 |
| PyrexiaGeneral disorders | 11/1864 | 7/709 | 1/1862 | 1/707 |
| NeutropeniaBlood and lymphatic system disorders | 9/1864 | 6/709 | 0/1862 | 0/707 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1864 | 0/709 | 15/1862 | 1/707 |
| DiarrhoeaGastrointestinal disorders | 8/1864 | 4/709 | 0/1862 | 0/707 |
| Cardiac failure congestiveCardiac disorders | 10/1864 | 1/709 | 1/1862 | 0/707 |
| Neutropenic sepsisInfections and infestations | 9/1864 | 1/709 | 0/1862 | 0/707 |
| PneumoniaInfections and infestations | 5/1864 | 1/709 | 8/1862 | 2/707 |
| DeathGeneral disorders | 0/1864 | 1/709 | 6/1862 | 1/707 |
| Atrial fibrillationCardiac disorders | 2/1864 | 0/709 | 6/1862 | 0/707 |
| Event | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID | Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up | Cohort B: SC Herceptin by SID Safety Follow-up |
|---|---|---|---|---|
| FatigueGeneral disorders | 381/1864 | 132/709 | 0/1862 | 0/707 |
| DiarrhoeaGastrointestinal disorders | 380/1864 | 130/709 | 0/1862 | 0/707 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 362/1864 | 133/709 | 0/1862 | 0/707 |
| NauseaGastrointestinal disorders | 274/1864 | 102/709 | 0/1862 | 0/707 |
| MyalgiaMusculoskeletal and connective tissue disorders | 260/1864 | 84/709 | 0/1862 | 0/707 |
| HeadacheNervous system disorders | 228/1864 | 73/709 | 0/1862 | 0/707 |
| AstheniaGeneral disorders | 221/1864 | 85/709 | 0/1862 | 0/707 |
| RashSkin and subcutaneous tissue disorders | 177/1864 | 74/709 | 0/1862 | 0/707 |
| ErythemaSkin and subcutaneous tissue disorders | 156/1864 | 74/709 | 0/1862 | 0/707 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 194/1864 | 49/709 | 0/1862 | 0/707 |
Intent-to-Treat (ITT) Population: All participants enrolled into the study regardless of whether treatment was received.
| Age, Continuous(years) | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID | Total |
|---|---|---|---|
| Mean | 54.0 ± 12.01 | 53.0 ± 11.32 | 53.7 ± 11.83 |
| Sex: Female, Male(Participants) | Cohort A: SC Herceptin by Needle/Syringe | Cohort B: SC Herceptin by SID | Total |
|---|---|---|---|
| Female | 1863 | 710 | 2573 |
| Male | 4 | 0 | 4 |
Showing the first 100 of 437 sites across 59 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Ran from May 2012 to primary completion in Mar 2015, 33 months.
Results were first posted in Apr 2017, 2 years 1 month after primary completion.
Of 272 industry-sponsored phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 63. This study's 33 months is below that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trastuzumab