Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Safety and Tolerability Study of Assisted- and Self-Administered Subcutaneous Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With Early HER2-Positive Breast Cancer (SafeHer)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01566721
First received: March 22, 2012
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted- and self-administered subcutaneous Hercept in (trastuzumab) as adjuvant therapy in patients with early HER2-positive breast cancer whose tumour has been excised. Patients will receive Herceptin 600 mg su bcutaneously every 3 weeks for 18 cycles, either by an assisted administration u sing a conventional syringe and needle (vial formulation, Cohort A) or with assi sted- and self-administration using a single-use injection device (SID) in selec ted patients (Cohort B). Anticipated time on study treatment is up to 1 year.


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab [Herceptin]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 [SafeHer Study]

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]
  • Patient satisfaction with trastuzumab SC using the single-use injection device (SID): SID satisfaction questionnaire (patients in cohort B who went on to self-administration of the study drug) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: May 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A: vial formulation Drug: trastuzumab [Herceptin]
600 mg sc by assisted administration using the vial formulation, into thigh, on Day 1 of each 3-week cycle, 18 cycles
Experimental: Cohort B: SID Drug: trastuzumab [Herceptin]
600 mg sc by single-use injection device (SID) and by self-administration in select patients, into thigh, on Day 1 of each 3-week cycle, 18 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female patients, >/= 18 years of age
  • 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 adjuvant treatment with trastuzumab
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Screening left ventricular ejection fraction (LVEF) >/= 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 or basal cell carcinoma and patients with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
  • Past history of ductal carcinoma in situ that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops
  • Metastatic disease
  • Inadequate bone marrow, hepatic or renal function
  • Serious cardiac or cardiovascular disease
  • Uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy
  • History of severe allergic or immunological reactions, e.g. difficult to control asthma
  • Pregnant or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566721

Contacts
Contact: Reference Study ID Number: MO28048 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 478 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01566721     History of Changes
Other Study ID Numbers: MO28048, 2011-005328-17
Study First Received: March 22, 2012
Last Updated: November 24, 2014
Health Authority: Pakistan: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014