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

March 2, 2020 updated by: Hoffmann-La Roche

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1006

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with HER2-positive early breast cancer initiated on treatment with subcutaneously administered trastuzumab.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HER2 Positive Breast Cancer Participants
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.
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.
Other Names:
  • Herceptin

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Time Frame: Baseline up to approximately 3 years (assessed according to routine 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)
Time Frame: Year 2
Year 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: Baseline up to approximately 3 years
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
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
Baseline, every 12 weeks up to Year 1
Mean Trastuzumab Dose
Time Frame: Baseline up to Year 1
Baseline up to Year 1
Duration of Trastuzumab Treatment
Time Frame: Baseline up to Year 1
Baseline up to Year 1
Percentage of Participants By Reason for Trastuzumab Discontinuation or Interruption
Time Frame: Baseline up to Year 1
Baseline up to Year 1
Percentage of Participants Who Received Concomitant Treatment (Chemotherapy or Any Other Treatment)
Time Frame: Baseline up to Year 1
Baseline up to Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 7, 2013

Primary Completion (ACTUAL)

January 31, 2019

Study Completion (ACTUAL)

January 31, 2019

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (ESTIMATE)

October 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28759

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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