An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

NCT01187381 | Terminated Results FDA Drug

• 1 other identifier: ML25235
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer. Data will be collected from female participants treated with trastuzumab according to the Summary of Product Characteristics and local protocols. Duration of observation for each participant is from therapy initiation until permanent discontinuation for any cause.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Treatment Duration With Trastuzumab in the Routine Clinical Practice

  Baseline up to 5 years

Secondary Outcomes (6)

• Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation

  Baseline up to 5 years

• Percentage of Participants Who Received Previous Neoadjuvant Therapy

  Baseline up to 5 years

• Percentage of Participants Who Had Surgical Procedure for Breast Cancer

  Baseline up to 5 years

• Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer

  Baseline up to 5 years

• Progression Free Survival

  Baseline uo tp 5 years

Study Arms (1)

Participants with Breast Cancer

Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, will be observed. Dosing and treatment duration of the trastuzumab will be at the discretion of the treating physician.

Drug: Trastuzumab

Interventions

Trastuzumab DRUG

Trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines

Also known as: Herceptin

Participants with Breast Cancer

Eligibility Criteria

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

Study Population

Female participants with early or metastatic HER2-positive breast cancer

You may qualify if:

• HER2-positive breast cancer
• Treated with trastuzumab in accordance with Summary of Product Characteristics and local protocols
• Written informed consent to data collection

You may not qualify if:

• Any contraindication to trastuzumab
• Clinically relevant cardiovascular disorder or disease

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Cluj Clinical County Hospital; Oncology Dept

Cluj-Napoca, 400006, Romania

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

Limitations and Caveats

Study was prematurely terminated because of missing data collection.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 24, 2010
• Study Start: April 14, 2010
• Primary Completion: October 15, 2015
• Study Completion: October 15, 2015
• Last Updated: October 20, 2017
• Results First Posted: October 20, 2017

Record last verified: 2017-05

Locations

RO (1)