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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

Description:

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).

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief 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
  • Official Title: A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: MO28048
  • SECONDARY ID: 2011-005328-17
  • NCT ID: NCT01566721

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
HerceptinTrastuzumabCohort A: SC Herceptin by Needle/Syringe

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Cohort A: SC Herceptin by Needle/SyringeExperimentalParticipants will receive SC Herceptin by an assisted administration using a conventional syringe and needle/vial formulation.
  • Herceptin
Cohort B: SC Herceptin by SIDExperimentalParticipants 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.
  • Herceptin

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed early invasive HER2-positive carcinoma of the breast with no
             evidence of residual, locally recurrent, or metastatic disease and defined as clinical
             Stage I to IIIC that is eligible for treatment with Herceptin

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%

        Exclusion Criteria:

          -  Previous neoadjuvant or adjuvant breast cancer treatment with an approved or
             investigational anti-HER2 agent

          -  History of other malignancy except for curatively treated carcinoma in situ of the
             cervix, basal cell carcinoma, or curatively treated malignancies (other than breast
             cancer) where the participant has been disease-free for at least 5 years

          -  Past history of ductal carcinoma in situ treated with any systemic therapy or with
             radiation therapy to the ipsilateral breast where invasive cancer subsequently
             developed

          -  Metastatic disease

          -  Inadequate bone marrow, hepatic, or renal function

          -  Serious cardiac or cardiovascular disease including uncontrolled hypertension or
             history of hypertensive crisis or hypertensive encephalopathy

          -  History of severe allergic or immunological reactions, such as difficult-to-control
             asthma

          -  Pregnant or lactating women
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
Time Frame:From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Disease-Free Survival (DFS)
Time Frame:From Baseline to time of event (up to approximately 8 years)
Safety Issue:
Description: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.
Measure:Percentage of Participants Who Died by Data Cutoff of 10 March 2015
Time Frame:From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
Safety Issue:
Description:The percentage of participants who died from any cause was reported.
Measure:Overall Survival (OS)
Time Frame:From Baseline to time of event (up to approximately 8 years)
Safety Issue:
Description:
Measure:Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Time Frame:Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)
Safety Issue:
Description: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.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

January 17, 2018