Phase II study evaluating the addition of elacestrant, an oral selective estrogen receptor degrader (SERD), to standard-of-care olaparib in patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutations – ELEMENT

HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutations, patients with hormone receptor (HR)-positive

PFS is defined as the time from randomization to first progression as assessed by the investigator, or death, whichever occurs first. Patients lost to follow up or progression-free at the end of the study will be censored at the date of last contact.

TTF is defined as time from randomization to discontinuation of treatment due to disease progression, treatment toxicity, patient´s preference, or death. Patients lost to follow up or still under treatment at the end of the study will be censored at the date of last contact., OS is defined as the time from randomization to death due to any reason. Patients lost to follow up or alive at the end of the study will be censored at the date of last contact., Patient reported BC-specific QoL as measured by FACT–ES., ORR is defined as the percentage of patients who have achieved either a confirmed complete response or partial response., CBR is defined as the percentage of patients who have achieved either a confirmed complete response or partial response, or stable disease for at least 24 weeks from randomization., Frequency and severity of AEs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0., Dose reductions, dose delays, treatment interruptions, and treatment discontinuation rates.

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