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

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ClinicalTrials.gov Identifier: NCT01959386
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment
Breast Neoplasms Drug: Trastuzumab

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Study Type : Observational
Actual Enrollment : 1006 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Practice Surveillance of the Use of Herceptin® Subcutaneous in Patients With HER2-Positive Early Breast Cancer (HerSCin)
Actual Study Start Date : November 7, 2013
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

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 Name: Herceptin




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with HER2-positive early breast cancer initiated on treatment with subcutaneously administered trastuzumab.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959386


Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01959386     History of Changes
Other Study ID Numbers: ML28759
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents