Back to resultsParticipant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer (PrefHER)
Primary Purpose
Breast Neoplasms
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Herceptin
Herceptin
Single-Use Injection Device
Single-Use Injection Device
Sponsored by
About this trial
This is an interventional health services research trial for Breast Neoplasms
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1: SC (SID) then IV Herceptin
Cohort 1: IV then SC (SID) Herceptin
Cohort 2: SC (Vial) then IV Herceptin
Cohort 2: IV then SC (Vial) Herceptin
Arm 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants by Preferred Method of Drug Administration
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.
Secondary Outcome Measures
Percentage of HCPs by Most Satisfied Method of Drug Administration
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.
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
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.
Percentage of Participants With an Event-Free Survival (EFS) Event
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.
Duration of EFS According to Kaplan-Meier Estimate
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.
3-Year EFS Rate
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.
Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
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.
Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01401166
Brief Title
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
Acronym
PrefHER
Official Title
A Randomized, Multi-Center Cross-Over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-Positive Early Breast Cancer (EBC)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
488 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: SC (SID) then IV Herceptin
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 1: IV then SC (SID) Herceptin
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 2: SC (Vial) then IV Herceptin
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 2: IV then SC (Vial) Herceptin
Arm Type
Experimental
Arm 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 Type
Drug
Intervention Name(s)
Herceptin
Other Intervention Name(s)
Trastuzumab
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Herceptin
Other Intervention Name(s)
Trastuzumab
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Single-Use Injection Device
Intervention Description
The SID will be used, containing Herceptin 600 mg per 5 milliliters (mL).
Intervention Type
Device
Intervention Name(s)
Single-Use Injection Device
Intervention Description
The SID will be used, containing Herceptin 600 mg per 5 mL.
Primary Outcome Measure Information:
Title
Percentage of Participants by Preferred Method of Drug Administration
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of HCPs by Most Satisfied Method of Drug Administration
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.
Time Frame
Week 24
Title
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
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.
Time Frame
Week 24
Title
Percentage of Participants With an Event-Free Survival (EFS) Event
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.
Time Frame
From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)
Title
Duration of EFS According to Kaplan-Meier Estimate
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.
Time Frame
From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)
Title
3-Year EFS Rate
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.
Time Frame
Year 3
Title
Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
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.
Time Frame
Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)
Title
Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
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.
Time Frame
Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
City
Sault Ste Marie
State/Province
Ontario
ZIP/Postal Code
P6A 2C4
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
City
Herning
ZIP/Postal Code
7400
Country
Denmark
City
Odense
ZIP/Postal Code
5000
Country
Denmark
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Bobigny
ZIP/Postal Code
93009
Country
France
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Caen
ZIP/Postal Code
14076
Country
France
City
La Tronche
ZIP/Postal Code
38700
Country
France
City
LeMans
ZIP/Postal Code
72000
Country
France
City
Lyon
ZIP/Postal Code
69373
Country
France
City
Paris
ZIP/Postal Code
75970
Country
France
City
Rennes
ZIP/Postal Code
35042
Country
France
City
St Cloud
ZIP/Postal Code
92210
Country
France
City
Strasbourg
ZIP/Postal Code
67065
Country
France
City
Berlin
ZIP/Postal Code
10713
Country
Germany
City
Deggendorf
ZIP/Postal Code
94469
Country
Germany
City
Essen
ZIP/Postal Code
45136
Country
Germany
City
Fuerstenwalde
ZIP/Postal Code
15517
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Magedburg
ZIP/Postal Code
39104
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Meiningen
ZIP/Postal Code
98617
Country
Germany
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
City
Ulm
ZIP/Postal Code
89073
Country
Germany
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Antella (FI)
State/Province
Toscana
ZIP/Postal Code
50011
Country
Italy
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
City
Ekaterinburg
ZIP/Postal Code
620905
Country
Russian Federation
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
City
Huesca
ZIP/Postal Code
22004
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
ZIP/Postal Code
28905
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Zamora
ZIP/Postal Code
49021
Country
Spain
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden
City
Gävle
ZIP/Postal Code
80187
Country
Sweden
City
Jonkoping
ZIP/Postal Code
55185
Country
Sweden
City
Sundsvall
ZIP/Postal Code
85186
Country
Sweden
City
Baden
ZIP/Postal Code
5405
Country
Switzerland
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
City
Adana
ZIP/Postal Code
01120
Country
Turkey
City
Ankara
ZIP/Postal Code
06018
Country
Turkey
City
Bornova, ?ZM?R
ZIP/Postal Code
35100
Country
Turkey
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
City
Chelmsford
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
City
Peterborough
ZIP/Postal Code
PE3 6DA
Country
United Kingdom
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28963915
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.
Results Reference
derived
PubMed Identifier
28549309
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.
Results Reference
derived
PubMed Identifier
26806010
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.
Results Reference
derived
PubMed Identifier
25070545
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.
Results Reference
derived
PubMed Identifier
23965225
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.
Results Reference
derived
Learn more about this trial
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
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