Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer

Overall survival in patients without a germline BRCA1/2 mutation

time from randomization to death from any cause in without a germline BRCA1/2 mutation

Time frame: assessed up to 120 months

Recurrence free interval in all patients

time from randomization to local recurrence, second primary, distant recurrence or death, whichever comes first in all patients

Time frame: assessed up to 120 months

Recurrence free interval in patients with an HR impaired tumor

time from randomization to local recurrence, second primary, distant recurrence or death, whichever comes first in patients with an HR impaired tumor

Time frame: assessed up to 120 months

Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03

Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03

Time frame: up to 30 days after end of treatment

cost-effectiveness measured by costs per quality-adjusted life years (QALYs)

cost-effectiveness measured by costs per quality-adjusted life years (QALYs)

Time frame: assessed up to 120 months

Patient reported outcomes

Patient reported outcomes; including quality of life (QoL) determined by a comprehensive panel of QoL questionnaires