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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01959386
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date October 8, 2013
First Posted Date October 10, 2013
Last Update Posted Date March 3, 2020
Actual Study Start Date November 7, 2013
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2017)
  • 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) ]
  • 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 ]
Original Primary Outcome Measures
 (submitted: October 8, 2013)
  • Pathological complete response (pCR) rate (for patients treated in the neo-adjuvant setting) [ Time Frame: approximately 1 year ]
  • Disease-free survival (DSF) rate after 2 years (for patients treated in the adjuvant setting) [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures
 (submitted: April 24, 2017)
  • Percentage of Participants with Adverse Events [ Time Frame: 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 ]
  • 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 ]
  • Mean Trastuzumab Dose [ Time Frame: Baseline up to Year 1 ]
  • Duration of Trastuzumab Treatment [ Time Frame: Baseline up to Year 1 ]
  • Percentage of Participants By Reason for Trastuzumab Discontinuation or Interruption [ Time Frame: Baseline up to Year 1 ]
  • Percentage of Participants Who Received Concomitant Treatment (Chemotherapy or Any Other Treatment) [ Time Frame: Baseline up to Year 1 ]
Original Secondary Outcome Measures
 (submitted: October 8, 2013)
  • Safety: Incidence of adverse events [ Time Frame: up to 3 years ]
  • Quality of life: EORTC QLQ-C30/QLQ-BR23 questionnaires [ Time Frame: approximately 1 year ]
  • Herceptin dose/treatment schedule/administration [ Time Frame: approximately 1 year ]
  • Concomitant chemotherapy/treatment/intervention [ Time Frame: approximately 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with HER2-positive early breast cancer initiated on treatment with subcutaneously administered trastuzumab.
Condition 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.
Other Name: Herceptin
Study Groups/Cohorts 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.
Intervention: Drug: Trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 24, 2017)
1006
Original Estimated Enrollment
 (submitted: October 8, 2013)
760
Actual Study Completion Date January 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01959386
Other Study ID Numbers ML28759
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date March 2020