Investigation of Gene Mutations in Patients With Triple-negative and Patients With HER2+ Breast Cancer Adenocarcinoma

March 15, 2022 updated by: Hellenic Cooperative Oncology Group

Investigation of Gene Mutations or Changes in Protein Expression,as Biomarkers With Prognostic/Predictive Value, in Patients With Triple-negative and in Patients With HER2+ Breast Cancer Adenocarcinoma,Who Underwent Intensive Adjuvant Chemotherapy

The present study is a transnational study in patients with high risk recurrent breast cancer who receive adjuvant chemotherapy with epirubicin and cyclophosphamide followed by docetaxel or paclitaxel.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This will be a retrospective analysis of patients with histologically confirmed triple-negative or HER2+ operable breast cancer (with high risk of recurrence) who are treated at Hellenic Cooperative Oncology Group (HeCOG)- affiliated departments of oncology. Patients who participate are 18 years or older, women of any menopausal status with triple-negative or HER2+ breast cancer who receive epirubicin and cyclophosphamide every two weeks followed by docetaxel every three weeks or weekly paclitaxel. Patients with HER2-positive tumors are treated with trastuzumab, initiated concurrently with the first cycle of docetaxel, for 52 weeks. Pertuzumab may be combined with trastuzumab only in patients with node-positive disease.Patients can be treated with hormone therapy and/or radiotherapy. The investigation of the potential biomarkers will be performed using in situ methods in Formalin fixed paraffin embedded (FFPE) tumor sections. More specific will be investigated the expression of estrogen and progesterone receptors, the expression of SPARC proteins, special cellular activation and metastasis systems and other important pathways in cell life and reproduction.

Statistical analysis: The primary endpoint of the study will be the progression-free survival (PFS), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. Second primary endpoint will be the overall survival (OS), defined as the time from treatment initiation to patient's death or last contact. Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test. The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model. The statistical analyses will be completed using the SAS software (SAS for Windows, version 9.3, SAS Institute Inc., Cary, NC).

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • George Fountzilas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This is a retrospective analysis of patients with histologically confirmed HER2- positive breast adenocarcinoma,triple-negative breast cancer with high risk of recurrence.

Patients have been treated in Hellenic Cooperative Oncology Group (HeCOG)- affiliated departments of oncology.

Description

Inclusion Criteria:

  • 18 years or older
  • Αny menopausal status is allowed
  • triple-negative breast cancer
  • HER2+ breast adenocarcinoma
  • tumor size <= 5 cm
  • presence of operable axillary lymph nodes or the presence of clinicopathological parameters indicating an intermediate or high risk of recurrence without the presence of infiltrated lymph nodes
  • Performance status (PS) = 0 or 1
  • adequate bone marrow function , heart, liver and kidney
  • no other history of previous neoplasm or other serious illness

Exclusion Criteria: -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with triple-negative breast cancer
Patients with histologically confirmed triple-negative breast cancer. Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology
Patients with HER2+ positive breast cancer
Patients with histologically confirmed HER2+ breast adenocarcinoma with high risk of recurrence. Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: From treatment initiation to the first documented disease progression, up to 5 years
From treatment initiation to the first documented disease progression, up to 5 years
Overall survival
Time Frame: from thee date of treatment initiation until death from any cause or date of last contact whichever occurred first, assessed up to 5 years
from thee date of treatment initiation until death from any cause or date of last contact whichever occurred first, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Cooperative Oncology Group

Investigators

  • Principal Investigator: George Foutzilas, MD, Hellenic Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2013

Primary Completion (Actual)

December 21, 2020

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE10/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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