Adjuvant Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer

April 2, 2021 updated by: Hellenic Cooperative Oncology Group

Adjuvant Dose-dense Sequential Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer: A Hellenic Cooperative Oncology Group (HeCOG) Study

This study was a transnational pooled analysis of biological material from patients with resected high risk breast cancer who had received adjuvant chemotherapy with epirubicin and cyclophosphamide followed by weekly docetaxel or weekly paclitaxel.

Study Overview

Status

Completed

Conditions

Detailed Description

This was a transnational analysis of biological material from patients with resected high risk breast cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG) affiliated departments of oncology. This study was a pooled analysis of two separate sequential feasibility studies who received the below described treatment. Patients who participated were 18 years old or older, women of any menopausal status who received epirubicin for 3 cycles every 2 weeks followed by 3 cycles with cyclophosphamide every 2 weeks followed 3 weeks later by 9 weekly cycles with docetaxel or paclitaxel. G-CSF was given on days 2-7 of each cycle during treatment with Epirubicin and cyclophosphamide. All premenopausal patients with receptor positive status received tamoxifen 20 mg p.o. daily for 5 years. All postmenopausal patients with receptor positive status were treated with anastrazole 1mg for 5 years. RT was required for all patients (pre- or post -menopausal), providing that they had either a partial mastectomy or tumor size > 5cm and /or more than 4 positive lymph nodes, irrespectively the type of surgery (conservative or radical).

Study Type

Observational

Enrollment (Actual)

89

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 transnational pooled analysis, feasibility study from two sequential studies with biological material from patients with confirmed breast cancer with high risk of recurrence. Patients have been treated in Hellenic Cooperative Oncology Group (HeCOG) affiliated departments of oncology.

Description

Inclusion Criteria:

  • Histology-confirmed epithelial cancer of the mammary gland.
  • Pre and post menopausal patients with early breast cancer and involved axillary lymph nodes (T 1-3 N1 M0) or high-risk N0 patients. A N0 patient is considered "high-risk" if she fulfills at least one of the following criteria; T>= 2cm, Estrogen Receptor (ER)/Progesterone receptor (PgR) negative, HER-2 3+, infiltration of blood or lymphatic vessels or nerves, grade 3.
  • White Blood Cell count (WBC) > 4 x 109 / l, platelets > 100 x 109 / l.
  • Serum creatinine, Aspartate aminotransferase (AST/SGOT),Alanine aminotransferase (ALT/SGPT), gamma-glutamyltransferase, serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital.
  • Performance status (WHO) 0 or 1.
  • Age >=18 years
  • Previous surgical treatment: Either radical surgery or, for a partial mastectomy, a histologically confirmed safe margin of 2 cm or more and the results of the axillary node dissection available.
  • No evidence of significant cardiac disease

Exclusion Criteria:

  • History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (BP> 200/110 mm Hg). A normal baseline Left Ventricular Ejection Fraction (LVEF) should be demonstrated by multigated acquisition (MUGA) scan or echocardiogram.
  • No previous antitumor chemotherapy or radiation
  • Time from surgery 2 to 4 weeks

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluating the feasibility profile of dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel.
Time Frame: Up to 147 days
Up to 147 days
Number of Participants with Treatment-Related Adverse Events treated with dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel.
Time Frame: Up to 147 days
Up to 147 days

Collaborators and Investigators

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

Sponsor

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)

February 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE10/04

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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