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

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ClinicalTrials.gov Identifier: NCT04365790
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Hellenic Cooperative Oncology Group

Brief Summary:
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.

Condition or disease
Breast Cancer

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).

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : April 18, 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: From treatment initiation to the first documented disease progression, up to 5 years ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Criteria

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: -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365790


Contacts
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Contact: George Fountzilas, MD fountzil@auth.gr
Contact: George Foutzilas, MD 00302106912520 hecogoff@otenet.gr

Locations
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Greece
George Fountzilas Recruiting
Athens, Greece
Contact: George Fountzilas, MD       fountzil@auth.gr   
Sponsors and Collaborators
Hellenic Cooperative Oncology Group
Investigators
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Principal Investigator: George Foutzilas, MD Hellenic Cooperative Oncology Group
Publications:
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Responsible Party: Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT04365790    
Other Study ID Numbers: HE10/13
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hellenic Cooperative Oncology Group:
Triple-negative breast cancer
HER2 positive breast adenocarcinoma
Additional relevant MeSH terms:
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Breast Neoplasms
Adenocarcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type