Patients with HR+ HER2- early breast cancer at intermediate risk of recurrence and eligible for adjuvant chemotherapy
Conditions
Brief summary
Invasive breast cancer-free survival according to the STEEP criteria is defined as the time from the date of randomization to the date of the first event of invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence, death (any cause) or invasive contralateral breast cancer as assessed by investigator. iBCFS will be censored if no iBCFS event is observed prior to the analysis cut-off date.
Detailed description
iDFS, DDFS, and OS according to STEEP criteria (Tolaney et al., JCO 2021)., Type of iBCFS event, AEs (adverse events) focusing on grade ≥2 according to NCI CTCAE v5.0., Change from baseline in EORTC QLQ-C30 and EORTC QLQ-BR42 questionnaires scores.
Interventions
DRUGDOXORUBICIN
DRUGANASTROZOLE
DRUGLETROZOLE
DRUGPACLITAXEL ALBUMIN-BOUND
DRUGEXEMESTANE
DRUGRIBOCICLIB
DRUGGOSERELIN
DRUGTRIPTORELIN
DRUGDOCETAXEL
DRUGCYCLOPHOSPHAMIDE
DRUGPACLITAXEL
DRUGLEUPRORELIN
DRUGEPIRUBICIN
Sponsors
Unicancer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive breast cancer-free survival according to the STEEP criteria is defined as the time from the date of randomization to the date of the first event of invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence, death (any cause) or invasive contralateral breast cancer as assessed by investigator. iBCFS will be censored if no iBCFS event is observed prior to the analysis cut-off date. | — |
Secondary
| Measure | Time frame |
|---|---|
| iDFS, DDFS, and OS according to STEEP criteria (Tolaney et al., JCO 2021)., Type of iBCFS event, AEs (adverse events) focusing on grade ≥2 according to NCI CTCAE v5.0., Change from baseline in EORTC QLQ-C30 and EORTC QLQ-BR42 questionnaires scores. | — |
Countries
France, Germany, Italy, Netherlands, Spain
Outcome results
None listed