A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

NCT02595762 | Completed

• 1 other identifier: ML28801
• Study Type: observational
• Target: 110
• Locations: 2 countries
• Sites: 12

Brief Summary

This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).

Conditions

Metastatic Breast Cancer; Locally Advanced Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Receiving Each Unique Treatment Regimen Overall

  Baseline up to approximately 8 years

• Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy

  Baseline up to approximately 8 years

• Percentage of Participants Receiving Each Unique Treatment Regimen Sequence

  Baseline up to approximately 8 years

• Progression-Free Survival (PFS)

  Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.

  From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)

Secondary Outcomes (22)

• Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

  Baseline up to approximately 8 years

• Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics

  Baseline up to approximately 8 years

• Percentage of Participants Receiving Each Treatment Regimen, by Country/Region

  Baseline up to approximately 8 years

• Overall Survival (OS)

  From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)

• Number of Treatment Regimens Received

  Baseline up to approximately 8 years

Study Arms (1)

Participants With HER2-Positive Breast Cancer

Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LABC/MBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. Participants will be followed until death, withdrawal of consent or study termination, whichever occurs first. Study protocol does not specify any particular drug or treatment regimen.

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

Disease registry data will be collected among participants with HER2-positive unresectable LABC or MBC.

You may qualify if:

• Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment

You may not qualify if:

• None specified

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Bank of Cyprus Oncology Center

Nicosia, 2006, Cyprus

Location

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

Athens, 115 22, Greece

Location

Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

Athens, 115 22, Greece

Location

ARETAIEION UNIVERSITY HOSPITAL; oncology unit

Athens, 115 28, Greece

Location

251 Air Force General Hospital-Oncology Clinic

Athens, 11525, Greece

Location

Agioi Anargyroi; 3Rd Dept. of Medical Oncology

Athens, 145 64, Greece

Location

IASO

Athens, 151 23, Greece

Location

IASO General Hospital of Athens

Athens, 155 62, Greece

Location

Attikon University Hospital; 4th Department of Internal Medicine

Haidari, 124 62, Greece

Location

Metropolitan Hospital; 2Nd Oncology Clinic

Piraeus, 185 47, Greece

Location

Theagenio Anticancer Hospital; 3Rd Oncology Clinic

Thessaloniki, 546 39, Greece

Location

Papageorgiou General Hospital; Medical Oncology

Thessaloniki, 564 29, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

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 28, 2015
• First Posted: November 3, 2015
• Study Start: October 30, 2016
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

GR (11); CY (1)