Pooled Analysis of Patients With Early-stage Breast Cancer Treated With Adjuvant Dose-dense Sequential Chemotherapy: a Hellenic Cooperative Oncology Group (HeCOG) Study. (ΗE_10R/22)

April 3, 2026 updated by: Hellenic Cooperative Oncology Group

Pooled Analysis of Individual Patient Data of Patients With Early-stage Breast Cancer Treated With Adjuvant Dose-dense Sequential Chemotherapy (Ddsc): a Hellenic Cooperative Oncology Group (HeCOG) Study

The goal of this observational study is to assess survival outcomes and treatment-related toxicity in patients with early-stage breast cancer receiving adjuvant therapies, using high-quality individual patient data pooled from seven clinical studies conducted by the Hellenic Cooperative Oncology Group (HeCOG), including 3 phase III trials and 4 observational studies. This study aims to assess long-term disease-free survival (DFS) and overall survival (OS), as well as the toxicity patterns associated with dose-dense sequential chemotherapy in intermediate or high-rsk patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5358

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, 11526

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes 5,378 patients with early-stage, surgically resected breast cancer of high or intermediate risk who participated in seven observational studies (three phase III trials and four observational studies) conducted by the Hellenic Cooperative Oncology Group (HeCOG). All patients received adjuvant dose-dense sequential chemotherapy (ddsc), and individual patient-level data were available for demographic, pathological, treatment, and outcome variables.

Description

Inclusion Criteria:

  • Patients with early-stage, surgically resected breast cancer (high or intermediate risk), randomized to receive adjuvant or neoadjuvant dose-dense sequential chemotherapy.

Exclusion Criteria:

  • Patients with metastatic or locally advanced breast cancer at initial diagnosis.

Patients who did not receive dose-dense sequential chemotherapy.

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
Early Breast Cancer Cohort
Patients with early-stage breast cancer included in pooled individual patient data from seven clinical studies conducted by the Hellenic Cooperative Oncology Group (HeCOG). Patients received adjuvant treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival
Time Frame: From date of diagnosis or surgery to first documented recurrence or death.
Disease-Free survival is defined as the time from diagnosis or surgery to the first documented recurrence of breast cancer (local, regional, or distant) or death from any cause. Patients without an event are censored at the last follow-up.
From date of diagnosis or surgery to first documented recurrence or death.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of diagnosis or surgery to death from any cause. Patients alive at last follow-up are censored at that date
OS is defined as the time from diagnosis or surgery to death from any cause. Patients alive at the last follow-up are censored. Analyses are performed using pooled individual patient data from studies conducted by the Hellenic Cooperative Oncology Group (HeCOG)
From date of diagnosis or surgery to death from any cause. Patients alive at last follow-up are censored at that date
Treatment-related toxicity
Time Frame: From the first dose of treatment until 5 years after the last dose
Τreatment-related toxicities observed during adjuvant or neoadjuvant therapy in patients with early breast cancer will be analyzed using pooled individual patient data from seven clinical studies conducted by the Hellenic Cooperative Oncology Group (HeCOG). This includes hematologic and non-hematologic adverse events reported during therapy.
From the first dose of treatment until 5 years after the last dose
Overall survival
Time Frame: From the date of diagnosis to the date of death
Overall survival was defined as the time from the date of diagnosis to the date of death. Patients are censored at last follow-up
From the date of diagnosis to the date of death

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)

December 15, 1996

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ΗE_10R/22

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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