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

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: Trastuzumab

• Registration Number: NCT01959386
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Study Start: 2013-11-07
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1006

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HER2 Positive Breast Cancer Participants	Trastuzumab	Participants with HER2 positive tumors who are considered for treatment with trastuzumab SC according to the judgement of physician and according to the actual summary of product characteristics will be observed for a period of approximately 1 year and will be followed for an additional 2 years.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Questionnaire Score	Baseline, every 12 weeks up to Year 1
Duration of Trastuzumab Treatment	Baseline up to Year 1
Percentage of Participants Who Received Concomitant Treatment (Chemotherapy or Any Other Treatment)	Baseline up to Year 1

Trial Locations

Locations (1)

Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde; 🇩🇪 Mainz, Germany