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-GB
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-31
• Last Update Posted: 2 October 2017

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 (neo)adjuvant chemotherapy must be completed, adjuvant radiotherapy may be ongoing
- Patients who have already received IV Herceptin must have at least 8 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