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

NCT01959386 | Completed FDA Drug

• 1 other identifier: ML28759
• Study Type: observational
• Target: 1,006
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Year 2

Secondary Outcomes (7)

• Percentage of Participants with Adverse Events

  Baseline up to approximately 3 years

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Scores

  Baseline, every 12 weeks up to Year 1

• European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Questionnaire Score

  Baseline, every 12 weeks up to Year 1

• Mean Trastuzumab Dose

  Baseline up to Year 1

• Duration of Trastuzumab Treatment

  Baseline up to Year 1

Study Arms (1)

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

Interventions

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.

Also known as: Herceptin

HER2 Positive Breast Cancer Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Contraindications according to the Summary of Product Characteristics of Herceptin SC
• Pregnant and breastfeeding women

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

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

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: November 7, 2013
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

DE (1)