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

Breast Neoplasms Clinical Trial

— HerSCin  

Official title:

Clinical Practice Surveillance of the Use of Herceptin® Subcutaneous in Patients With HER2-Positive Early Breast Cancer (HerSCin)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959386
• Other study ID #: ML28759
• Status: Completed
• Start date: November 7, 2013
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1006
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Trastuzumab
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.

Locations

Country	Name	City	State
Germany	Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Percentage of Participants with Adverse Events		Baseline up to approximately 3 years
Secondary	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
Secondary	European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Questionnaire Score		Baseline, every 12 weeks up to Year 1
Secondary	Mean Trastuzumab Dose		Baseline up to Year 1
Secondary	Duration of Trastuzumab Treatment		Baseline up to Year 1
Secondary	Percentage of Participants By Reason for Trastuzumab Discontinuation or Interruption		Baseline up to Year 1
Secondary	Percentage of Participants Who Received Concomitant Treatment (Chemotherapy or Any Other Treatment)		Baseline up to Year 1