Long-term Outcome of HER2-amplified Metastatic Breast Cancer: A Retrospective Analysis

NCT02560311 | Unknown

• 1 other identifier: KEK-ZH-Nr.2015-0050
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to analyze cases of human epidermal growth factor receptor (HER) 2-positive metastatic breast cancer (MBC) of the last 10 years at the University Hospital of Zurich to assess the efficacy of the treatment with trastuzumab in HER2-positive MBC and to find out associations between different variables and the outcome. The aim is to find out probable prognostic factors and patterns of disease progression. Prognostic factors could optimize treatment approaches and result in a delay of disease progression.

Conditions

ERBB2; Breast Cancer; Metastatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• Time to disease progression

  time from commencing trastuzumab (or other anti-HER2 therapy) to the time of disease progression or death

  up to 120 months

Secondary Outcomes (1)

• Response duration

  up to 120 months

Study Arms (1)

HER2+ metastatic breast cancer

Other: observation

Interventions

observation OTHER

HER2+ metastatic breast cancer

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with a human epidermal growth factor receptor (HER) 2+ breast cancer in metastatic stage (M1)

You may qualify if:

• Received at least 1 dose of trastuzumab in metastatic setting at the University hospital of Zurich from 01/2004 to 12/2014.
• HER2+ status confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) ≥ 2.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

UniversitätsSpital Zürich, Klinik für Gynäkologie

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Konstantin J Dedes, Dr.med.

  UniversitätsSpital Zürich, Klinik für Gynäkologie

  PRINCIPAL INVESTIGATOR

• Bernhard Pestalozzi, Prof.Dr.med.

  UniversitätsSpital Zürich, Klinik für Onkologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantin J Dedes, Dr.med.

CONTACT

+41 44 255 11 11; konstantin.dedes@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 25, 2015
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: February 1, 2016
• Last Updated: September 25, 2015

Record last verified: 2015-09

Locations

CH (1)