Breast Neoplasms
Conditions
Brief summary
This observational study will evaluate the efficacy, safety, tolerability and participant reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants with HER2-positive early breast cancer in routine clinical practice. Data from eligible participants will be collected for the duration of their treatment (approximately 1 year) and for 1-2 years of follow-up.
Interventions
DRUGTrastuzumab
Participants will be receiving trastuzumab as part of their treatment for breast cancer according to the judgement of physician and according to the actual summary of product characteristics. The study protocol does not influence the physician's decision regarding diagnostics, therapy or frequency of medical examination during or after the treatment.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the breast * HER2-positive tumor * Eligible for neo-adjuvant or adjuvant treatment with trastuzumab SC according to the judgement of the physician Note: As of participant recruitment (date of participant informed consent), retrospective documentation is allowed but limited to up to 9 weeks after initial start of therapy with trastuzumab SC
Exclusion criteria
* Contraindications according to the Summary of Product Characteristics of Herceptin SC * Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Pathologic Complete Response (pCR) (For Participants Treated in Neo-Adjuvant Setting), According to Response Evaluation Criteria in Solid Tumor (RECIST), or Modified RECIST, or Cheson Criteria (As per Center Practice) | Baseline up to approximately 3 years (assessed according to routine center practice) |
| Percentage of Participants Who Were Alive and Disease Free at Year 2 (For Participants Treated in the Adjuvant Setting), According to RECIST, or Modified RECIST, or Cheson Criteria (As per Center Practice) | Year 2 |
Secondary
| Measure | Time frame |
|---|---|
| European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Questionnaire Score | Baseline, every 12 weeks up to Year 1 |
| Mean Trastuzumab Dose | Baseline up to Year 1 |
| Percentage of Participants with Adverse Events | Baseline up to approximately 3 years |
| Percentage of Participants By Reason for Trastuzumab Discontinuation or Interruption | Baseline up to Year 1 |
| Percentage of Participants Who Received Concomitant Treatment (Chemotherapy or Any Other Treatment) | Baseline up to Year 1 |
| Duration of Trastuzumab Treatment | Baseline up to Year 1 |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Scores | Baseline, every 12 weeks up to Year 1 |
Countries
Germany
Outcome results
None listed