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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07521397

Acronym

ΗE_10R/22

Enrollment

5358

Registered

2026-04-09

Start date

1996-12-15

Completion date

2022-07-15

Last updated

2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvant Chemotherapy, Breast Cancer, Early Stage Breast Cancer, Overall Survival, Prognosis Breast Cancer

Keywords

dose-dense sequential chemotherapy, breast cancer, prognostic biomarker

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Disease-Free Survival	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

Measure	Time frame	Description
Overall survival	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	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.

Countries

Greece

Outcome results