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 Type
OBSERVATIONAL
Enrollment
5,358
Unnamed facility
Athens, Greece
Disease-Free Survival
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.
Time frame: From date of diagnosis or surgery to first documented recurrence or death.
Overall survival
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)
Time frame: 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
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.
Time frame: From the first dose of treatment until 5 years after the last dose
Overall survival
Overall survival was defined as the time from the date of diagnosis to the date of death. Patients are censored at last follow-up
Time frame: From the date of diagnosis to the date of death
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