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 August 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: August 19, 2014
Last verified: August 2014

March 22, 2012
August 19, 2014
May 2012
January 2020   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01566721 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Disease-free survival (recurrence assessed according to ASCO 2006 Guideline for Breast Cancer Follow-up) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Patient satisfaction with trastuzumab SC single use injection device (SID): SID Satisfaction Questionnaire (cohort B only) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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]

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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
  • 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
  • Experimental: Cohort A: vial formulation
    Intervention: Drug: trastuzumab [Herceptin]
  • Experimental: Cohort B: SID
    Intervention: Drug: trastuzumab [Herceptin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
January 2020
January 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: MO28048 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
Albania,   Algeria,   Argentina,   Australia,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czech Republic,   Dominican Republic,   Ecuador,   Egypt,   El Salvador,   Finland,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   Hungary,   Indonesia,   Ireland,   Italy,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   Morocco,   Netherlands,   New Zealand,   Norway,   Pakistan,   Panama,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Singapore,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Arab Emirates,   United Kingdom,   Uruguay,   Venezuela,   Vietnam
 
NCT01566721
MO28048, 2011-005328-17
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP