A study to evaluate both patients' preference and doctors' and nurses' satisfaction with subcutaneous administration(under the skin) of trastuzumab in patients with breast cancer

Phase 1

Conditions: HER2-positive early breast cancer
MedDRA version: 14.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-024099-25-DE

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 400

Inclusion Criteria

- Female patients, >/= 18 years of age
- HER2-positive breast cancer
- No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy (neoadjuvant or adjuvant)
- All adjuvant chemotherapy must be completed, adjuvant radiotherapy may be ongoing
- Patients who have already received IV Herceptin must have at least 10 out of the total planned 18 3-week cycles remaining
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix or basal cell carcinoma, or other curatively treated malignancies that have been disease-free for at least 5 years
- Inadequate bone marrow function
- Impaired liver function
- Inadequate renal function
- Serious cardio-vascular disease
- HIV or hepatitis B (HBV) or C (HCV) infection
- Prior maximum cumulative dose of doxorubicin > 360 mg/m2 or epirubicin > 720 mg/m2 or equivalent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the proportion of patients indicating an overall preference for either the subcutaneous (SC) or the intravenous (IV) route of administration;Secondary Objective: • Healthcare professional satisfaction with SC trastuzumab <br>• Healthcare professional perceived time savings with SC trastuzumab <br>• Safety and tolerability <br>• Efficacy – event-free survival (EFS)<br>• Immunogenicity of trastuzumab and recombinant human hyaluronidase (rHuPH20) <br>;Primary end point(s): The primary endpoint will be assessed by the following question on the second patient interview (PINT2) : All things considered which method of administration did you prefer?”;Timepoint(s) of evaluation of this end point: Once the last patient has completed the first 8 cycles of study treatment, i.e. 4 cycles SC trastuzumab and 4 cycles IV trastuzumab

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Health Care Professional satisfaction with SC trastuzumab’ <br>- ‘Health Care Professional perceived time savings with SC trastuzumab’ <br>- Safety endpoints<br>- Efficacy endpoint<br>- Immunogenicity of trastuzumab and recombinant human hyaluronidase (rHuPH20). <br>;Timepoint(s) of evaluation of this end point: See Protocol MO22982, section 8.2.1.2 Secondary Variables

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