A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Posi… (NCT03312738) | Clinical Trial Compass
CompletedPhase 2
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
China159 participantsStarted 2017-09-15
Plain-language summary
This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on letrozole or anastrozole.
Who can participate
Age range18 Years
SexFEMALE
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Key Inclusion Criteria:
* Chinese Postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer. Locally advanced breast cancer must not be amenable to curative treatment by surgery or radiotherapy.
* Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
* Postmenopausal women. Postmenopausal status was defined either by:
* Prior bilateral oophorectomy
* Or age ≥60
* Or age \< 60 and amenorrhea for 12 or more months
* Recurrence or progression on prior NSAI was defined as:
* Recurrence while on, or within one year (12 months) of end of adjuvant treatment with letrozole or anastrozole
* Or Progression while on or within one month (30 days) of the end of prior treatment with letrozole or anastrozole
* Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrollment
* Patient had as per RECIST 1.1
* measurable disease or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease.
* non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease.
* Patient was able to swallow and retain oral medication
* Patient met the hematologic and biochemistery laboratory values at the screening visit
* Patient had a WHO performance status ≤2
* Written informed consent obtained prior to any screening procedures
Exclusion Criteria:
* HER2-overexpressing patients by local laborat…
What they're measuring
1
Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessment
Timeframe: From randomization up to date of first documented progression or death, assessed up to approximately 3.5 years