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NCT Number: NCT01959386

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Mainz, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trastuzumab

Drug

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

Primary outcomes

  1. 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)

  2. 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

  1. Percentage of Participants with Adverse Events

    Time frame: Baseline up to approximately 3 years

  2. 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

  3. 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

  4. Mean Trastuzumab Dose

    Time frame: Baseline up to Year 1

  5. Duration of Trastuzumab Treatment

    Time frame: Baseline up to Year 1

  6. Percentage of Participants By Reason for Trastuzumab Discontinuation or Interruption

    Time frame: Baseline up to Year 1

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

    Time frame: Baseline up to Year 1

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: HerSCin

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2013
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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