TriangleNCT01401166 · CITED IN SOURCE DOCUMENTS
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2017-03-06
This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Participants by Preferred Method of Drug Administration
Percentage of HCPs by Most Satisfied Method of Drug Administration
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
Percentage of Participants With an Event-Free Survival (EFS) Event
Duration of EFS According to Kaplan-Meier Estimate
3-Year EFS Rate
Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Histologically confirmed HER2-positive primary breast cancer * No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neo-adjuvant or adjuvant) * Completed neo-adjuvant chemotherapy prior to entry, if received * At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV Herceptin * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: * History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or other curatively treated malignancies of which the participant has been disease-free for at least 5 years * Inadequate bone marrow function * Impaired liver function * Inadequate renal function * Serious cardiovascular disease * Human immunodeficiency virus or hepatitis B or C infection * Prior maximum cumulative dose of doxorubicin greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or equivalent
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin will be administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin will be given. In the continuation period, participants will receive IV Herceptin for up to 10 remaining cycles. Administration will be performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period will be offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP.
- intervention Names
- Drug: Herceptin
- Device: Single-Use Injection Device
- label
- Cohort 1: SC (SID) then IV Herceptin
- type
- EXPERIMENTAL
- description
- Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin will be given, and during Cycles 5 to 8, SC Herceptin will be administered via SID. In the continuation period, participants will receive IV Herceptin for up to 10 remaining cycles. Administration will be performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period will be offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP.
- intervention Names
- Drug: Herceptin
- Device: Single-Use Injection Device
- label
- Cohort 1: IV then SC (SID) Herceptin
- type
- EXPERIMENTAL
- description
- Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin will be administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin will be given. In the continuation period, participants will receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration will be performed by HCP throughout the study.
- intervention Names
- Drug: Herceptin
- label
- Cohort 2: SC (Vial) then IV Herceptin
- type
- EXPERIMENTAL
- description
- Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin will be given, and during Cycles 5 to 8, SC Herceptin will be administered via handheld syringe using the vial formulation. In the continuation period, participants will receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration will be performed by HCP throughout the study.
- intervention Names
- Drug: Herceptin
- label
- Cohort 2: IV then SC (Vial) Herceptin
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Cohort 1: SC (SID) then IV Herceptin
- description
- Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 milligrams per kilogram (mg/kg) for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 milligrams (mg) for both the SID and vial formulations for all cycles where SC Herceptin is given.
- name
- Herceptin
- other Names
- Trastuzumab
- type
- DRUG
- arm Group Labels
- Cohort 1: IV then SC (SID) Herceptin
- Cohort 2: IV then SC (Vial) Herceptin
- Cohort 2: SC (Vial) then IV Herceptin
- description
- Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 mg/kg for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 mg for both the SID and vial formulations for all cycles where SC Herceptin is given.
- name
- Herceptin
- other Names
- Trastuzumab
- type
- DRUG
- arm Group Labels
- Cohort 1: SC (SID) then IV Herceptin
- description
- The SID will be used, containing Herceptin 600 mg per 5 milliliters (mL).
- name
- Single-Use Injection Device
- type
- DEVICE
- arm Group Labels
- Cohort 1: IV then SC (SID) Herceptin
- description
- The SID will be used, containing Herceptin 600 mg per 5 mL.
- name
- Single-Use Injection Device
- type
- DEVICE
Study design
- allocation
- RANDOMIZED
- intervention Model
- CROSSOVER
- masking Info
- masking
- NONE
- primary Purpose
- HEALTH_SERVICES_RESEARCH
Enrollment
- count
- 488
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.
- measure
- Percentage of Participants by Preferred Method of Drug Administration
- time Frame
- Week 24
- secondary Outcomes
- description
- The method of drug administration with which HCPs were most satisfied (IV or SC Herceptin) was assessed via questionnaire with each HCP using the question, "All things considered, with which method of administration were you most satisfied?" at the end of the crossover period (Week 24). The percentage of HCPs who were most satisfied with each method of drug administration was reported.
- measure
- Percentage of HCPs by Most Satisfied Method of Drug Administration
- time Frame
- Week 24
- description
- The time required to perform each method of drug administration was assessed via questionnaire with each HCP by asking to rate the amount of time it took to administer each method of drug administration (IV or SC Herceptin) at the end of the crossover period (Week 24). Time was rated in the following time block categories: less than (\<) 5 minutes, 6 to 10 minutes, 11 to 15 minutes, 16 to 20 minutes, and greater than (\>) 20 minutes. Responses of "Not Sure" and "Unknown" were also allowed. The percentage of HCPs who rated the amount of time in each of the categories was reported.
- measure
- Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
- time Frame
- Week 24
- description
- EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The percentage of participants who had an EFS event at any time on study was reported.
- measure
- Percentage of Participants With an Event-Free Survival (EFS) Event
- time Frame
- From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)
- description
- EFS was defined as the time from randomization to a local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The median duration of EFS and corresponding 95 percent (%) CI according to Kaplan-Meier estimates were planned to be reported and expressed in months.
- measure
- Duration of EFS According to Kaplan-Meier Estimate
- time Frame
- From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)
- description
- EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The proportion of participants without an EFS event (i.e., the EFS rate) and corresponding 95% CI at 3 years after randomization was reported.
- measure
- 3-Year EFS Rate
- time Frame
- Year 3
- description
- Participants who performed self-administration of SC Herceptin via SID were given an evaluation questionnaire during the continuation period (Weeks 25 to 52) after their first self-administration. Participants responded to 5 statements about their comfort with self-injection, the convenience of the SID, their self-confidence using the SID, their satisfaction with the SID, and whether they would consider using the SID again in the future. Each statement used a 5-item rating scale with responses from "Strongly Disagree" to "Strongly Agree". The percentage of participants with a positive response (either "Agree" or "Strongly Agree") to each questionnaire statement was reported.
- measure
- Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
- time Frame
- Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)
- description
- Participants in Cohort 1 provided blood samples for immunogenicity testing to assess for anti-drug antibodies (ADAs) to trastuzumab or rHuPH20, a component of the SC Herceptin formulation. The percentage of participants who were trastuzumab ADA-positive and the percentage of participants who were rHuPH20 ADA-positive were each reported.
- measure
- Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
- time Frame
- Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)
Full study description
- brief Summary
- This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.
Source references
- references
- citation
- Pivot X, Verma S, Fallowfield L, Muller V, Lichinitser M, Jenkins V, Sanchez Munoz A, Machackova Z, Osborne S, Gligorov J; PrefHer Study Group. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017 Nov;86:82-90. doi: 10.1016/j.ejca.2017.08.019. Epub 2017 Sep 28.
- pmid
- 28963915
- type
- DERIVED
- citation
- Gligorov J, Curigliano G, Muller V, Knoop A, Jenkins V, Verma S, Osborne S, Lauer S, Machackova Z, Fallowfield L, Pivot X. Switching between intravenous and subcutaneous trastuzumab: Safety results from the PrefHer trial. Breast. 2017 Aug;34:89-95. doi: 10.1016/j.breast.2017.05.004. Epub 2017 May 23.
- pmid
- 28549309
- type
- DERIVED
- citation
- De Cock E, Pivot X, Hauser N, Verma S, Kritikou P, Millar D, Knoop A. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016 Mar;5(3):389-97. doi: 10.1002/cam4.573. Epub 2016 Jan 25.
- pmid
- 26806010
- type
- DERIVED
- citation
- Pivot X, Gligorov J, Muller V, Curigliano G, Knoop A, Verma S, Jenkins V, Scotto N, Osborne S, Fallowfield L; PrefHer Study Group. Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol. 2014 Oct;25(10):1979-1987. doi: 10.1093/annonc/mdu364. Epub 2014 Jul 28.
- pmid
- 25070545
- type
- DERIVED
- citation
- Pivot X, Gligorov J, Muller V, Barrett-Lee P, Verma S, Knoop A, Curigliano G, Semiglazov V, Lopez-Vivanco G, Jenkins V, Scotto N, Osborne S, Fallowfield L; PrefHer Study Group. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013 Sep;14(10):962-70. doi: 10.1016/S1470-2045(13)70383-8. Epub 2013 Aug 19.
- pmid
- 23965225
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- all response rate in patients whose tumors tested as CTA 3+ was 18% while in those that tested as CTA 2+, it was 6%. 14.3 Patient Experience The PrefHER study (NCT01401166) was a randomized, multi-center, two-arm, cross-over trial conducted in 240 patients with HER2-positive breast cancer undergoing neoadjuvant or adjuvant treatm
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Preserved source evidence · Not medical advice