A Study of Trastuzumab Subcutaneous in Participants With Human Epidermal Growth Factor Receptor-2 (HER2) Positive Early Breast Cancer

N/ACompletedNCT01959386

Hoffmann-La Roche1,006 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,006

Conditions

Breast Neoplasms

Interventions

TrastuzumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

Mainz, Germany

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: Year 2

Secondary Outcomes

Percentage of Participants with Adverse Events

Time frame: Baseline up to approximately 3 years

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Scores

Time frame: Baseline, every 12 weeks up to Year 1

European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Questionnaire Score

Time frame: Baseline, every 12 weeks up to Year 1

Mean Trastuzumab Dose

Time frame: Baseline up to Year 1

Duration of Trastuzumab Treatment

Time frame: Baseline up to Year 1

Percentage of Participants By Reason for Trastuzumab Discontinuation or Interruption

Time frame: Baseline up to Year 1

Percentage of Participants Who Received Concomitant Treatment (Chemotherapy or Any Other Treatment)

Data from ClinicalTrials.gov

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