Clinical trial NCT01959386: A Study of Trastuzumab Subcutaneous in Participants With Human Epidermal Growth Factor Receptor-2 (HER2) Positive Early Breast Cancer
Official title: Clinical Practice Surveillance of the Use of Herceptin® Subcutaneous in Patients With HER2-Positive Early Breast Cancer (HerSCin)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 1006
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with HER2-positive early breast cancer initiated on treatment with subcutaneously administered trastuzumab.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Baseline up to approximately 3 years (assessed according to routine center practice)
measure: 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)
timeFrame: Year 2
Secondary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: Baseline up to approximately 3 years
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Scores
timeFrame: Baseline, every 12 weeks up to Year 1
measure: European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Questionnaire Score
timeFrame: Baseline, every 12 weeks up to Year 1
measure: Mean Trastuzumab Dose
timeFrame: Baseline up to Year 1
measure: Duration of Trastuzumab Treatment
timeFrame: Baseline up to Year 1
measure: Percentage of Participants By Reason for Trastuzumab Discontinuation or Interruption
timeFrame: Baseline up to Year 1
measure: Percentage of Participants Who Received Concomitant Treatment (Chemotherapy or Any Other Treatment)
timeFrame: Baseline up to Year 1
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: