NCT04365790

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2013

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

7.7 years

First QC Date

April 24, 2020

Last Update Submit

March 7, 2023

Conditions

Breast Cancer

Keywords

Triple-negative breast cancerHER2 positive breast adenocarcinoma

Outcome Measures

Primary Outcomes (2)

  • Progression free survival

    From treatment initiation to the first documented disease progression, up to 5 years

  • Overall survival

    from thee date of treatment initiation until death from any cause or date of last contact whichever occurred first, assessed up to 5 years

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Fountzilas

Athens, Greece

Location

Related Publications (7)

  • Norton L. Theoretical concepts and the emerging role of taxanes in adjuvant therapy. Oncologist. 2001;6 Suppl 3:30-5. doi: 10.1634/theoncologist.6-suppl_3-30.

    PMID: 11346683BACKGROUND

  • Fisher B, Bauer M, Wickerham DL, Redmond CK, Fisher ER, Cruz AB, Foster R, Gardner B, Lerner H, Margolese R, et al. Relation of number of positive axillary nodes to the prognosis of patients with primary breast cancer. An NSABP update. Cancer. 1983 Nov 1;52(9):1551-7. doi: 10.1002/1097-0142(19831101)52:93.0.co;2-3.

    PMID: 6352003BACKGROUND

  • Nissen-Meyer R, Kjellgren K, Mansson B. Adjuvant chemotherapy in breast cancer. Recent Results Cancer Res. 1982;80:142-8. doi: 10.1007/978-3-642-81685-7_24.

    PMID: 7036276BACKGROUND

  • Meyer JS, McDivitt RW, Stone KR, Prey MU, Bauer WC. Practical breast carcinoma cell kinetics: review and update. Breast Cancer Res Treat. 1984;4(2):79-88. doi: 10.1007/BF01806389.

    PMID: 6378283BACKGROUND

  • Kononen J, Bubendorf L, Kallioniemi A, Barlund M, Schraml P, Leighton S, Torhorst J, Mihatsch MJ, Sauter G, Kallioniemi OP. Tissue microarrays for high-throughput molecular profiling of tumor specimens. Nat Med. 1998 Jul;4(7):844-7. doi: 10.1038/nm0798-844.

    PMID: 9662379BACKGROUND

  • Skacel M, Skilton B, Pettay JD, Tubbs RR. Tissue microarrays: a powerful tool for high-throughput analysis of clinical specimens: a review of the method with validation data. Appl Immunohistochem Mol Morphol. 2002 Mar;10(1):1-6. doi: 10.1097/00129039-200203000-00001.

    PMID: 11893029BACKGROUND

  • Camp RL, Charette LA, Rimm DL. Validation of tissue microarray technology in breast carcinoma. Lab Invest. 2000 Dec;80(12):1943-9. doi: 10.1038/labinvest.3780204.

    PMID: 11140706BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • George Foutzilas, MD

    Hellenic Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

April 18, 2013

Primary Completion

December 21, 2020

Study Completion

September 1, 2023

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)