An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT02286362
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 510
- Aged >/= 18 years
- Patients with HER2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant HER2+ treatment
- Patients for whom the investigator has decided to start a treatment with Herceptin SC
- Trastuzumab treatment naive or non-naive (previously intravenous treatment)
- Informed consent
- Patients previously treated with Herceptin SC treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (composite outcome measure): Incidence, nature, and severity according to NCI-CTCAE v. 4.0 of: adverse events (AEs), serious AEs, grade >/= 3 AEs, non-serious adverse drug reaction or causality unknown, AESI (congestive heart failure) approximately 13 months
- Secondary Outcome Measures
Name Time Method Number of modalities regarding dose and injection site of Herceptin SC administration Up to 12 months Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire Every 3 months, up to 12 months Demographic data Up to 12 months
Trial Locations
- Locations (97)
Clinique Du Docteur Calabet; Cromg
🇫🇷Agen, France
C H Du Pays D'Aix En Provence; Hopital De Jour
🇫🇷Aix En Provence, France
Ch Du Pays D Aix; Maternite Gynecologie
🇫🇷Aix En Provence, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
🇫🇷Aix En Provence, France
Centre Hospitalier Albi; Oncologie
🇫🇷Albi, France
Clinique Claude Bernard; Onco Hematologie
🇫🇷Albi, France
Hopital Prive D Antony; Oncologie
🇫🇷Antony, France
Cmc De Tronquieres;Chimiotherapie Et Radiotherapie
🇫🇷Aurillac, France
Ch D Auxerre; Oncologie
🇫🇷Auxerre, France
Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie
🇫🇷Bastia, France
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