Pooled Analysis of Patients With Early-stage Breast Cancer Treated With Adjuvant Dose-dense Sequential Chemotherapy: 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.

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Key information

Conditions

Breast Cancer Adjuvant Chemotherapy Breast Diseases Breast Neoplasms Early Stage Breast Cancer Neoplasms Neoplasms by Site Overall Survival Prognosis Breast Cancer Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Athens, 11526, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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)
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.
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

Sponsors and collaborators

Lead sponsor

Hellenic Cooperative Oncology Group

Other

Registry information

Official study title

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

Acronym: ΗE_10R/22

Important dates

Study start: 1996
Primary completion: 2022
Study completion: 2022
First posted: Apr 9, 2026
Registry last updated: Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed