Patients with 1-3 positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer with recurrence Score (RS) of 25 or Less
Conditions
Brief summary
DFS: Invasive disease-free survival (DFS) - time from the second registration (randomization) to local, regional, or distant recurrence, new invasive primary, or death due to any cause. The STEEP definition of invasive disease-free survival (IDFS) is used, although it is referred to here by the more common acronym DFS. Survival times are censored at time of last follow-up for individuals who did not have any event meeting the above definition.
Detailed description
OS: Overall survival (OS) - time from the second registration (randomization) to death due to any cause. Survival times are censored at time of last follow-up for individuals who are not known to have died., DDFS: Distant disease-free survival (DDFS) - time from second registration to distant recurrence, new invasive primary, or death due to any cause. Patients who have local or regional recurrence are continued to be followed for a distant event or death. Survival times are censored at time of last follow-up for individuals who are not known to have died and have not had a distant recurrence or new primary., LDFI: Local-regional disease-free interval (LDFI) - time from second registration to local/regional recurrence. 3 Patients who have distant recurrence or a new primary or who die without recurrence are censored at time of this event. The analysis of this endpoint must account for informative censoring using a competing risk framework. Survival times are also censored at time of last follow-up for individuals who are not known to have died and have had a recurrence or new primary., Toxicity: Toxicities using standard NCI-CTCAE criteria (CTCAE Version 4.0).
Interventions
DRUGEpirubicin 2 mg/ml Solution for Injection
DRUGTamoxifen 20 mg Tablets
DRUGEndoxana Injection 500 mg Powder for Solution for Injection
DRUGAnastrozole 1 mg film-coated tablets
Sponsors
Cancer Trials Ireland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS: Invasive disease-free survival (DFS) - time from the second registration (randomization) to local, regional, or distant recurrence, new invasive primary, or death due to any cause. The STEEP definition of invasive disease-free survival (IDFS) is used, although it is referred to here by the more common acronym DFS. Survival times are censored at time of last follow-up for individuals who did not have any event meeting the above definition. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS: Overall survival (OS) - time from the second registration (randomization) to death due to any cause. Survival times are censored at time of last follow-up for individuals who are not known to have died., DDFS: Distant disease-free survival (DDFS) - time from second registration to distant recurrence, new invasive primary, or death due to any cause. Patients who have local or regional recurrence are continued to be followed for a distant event or death. Survival times are censored at time of last follow-up for individuals who are not known to have died and have not had a distant recurrence or new primary., LDFI: Local-regional disease-free interval (LDFI) - time from second registration to local/regional recurrence. 3 Patients who have distant recurrence or a new primary or who die without recurrence are censored at time of this event. The analysis of this endpoint must account for informative censoring using a competing risk framework. Survival times are also censored at | — |
Countries
Ireland
Outcome results
None listed