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
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms; Disease Progression; Recurrence
Intervention: Everolimus; Exemestane; Everolimus Placebo
Intervention description: Everolimus was formulated as tablets of 5 mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) was administered in a blinded manner by continuous oral daily dosing.; Commercially available exemestane was supplied as 25 mg tablets. Exemestane was administered as continuous oral daily dose of 25 mg tablets.; Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) was administered in a blinded manner by continuous oral daily dosing.
Intervention MeSH terms: Everolimus; Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 159.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: everolimus; exemestane; advanced Breast Cancer; non-steroidal aromatase inhibitors; breast carcinoma; breast cancer; breast lump; HER2 negative; breast cancer progression

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.
    

Eligibility criteria:

        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 laboratory testing (IHC 3+ staining or in situ
             hybridization positive), based on the most recent test.

          -  Patients who had received more than one chemotherapy line for ABC

          -  Patients with symptomatic visceral disease and candidates to chemotherapy

          -  Patients with only non-measurable lesions other than lytic or mixed (lytic and
             blastic) bone metastasis (e.g. pleural effusion, ascites etc.)

          -  Patients receiving concomitant immunosuppressive agents or chronic corticosteroids
             used at the time of study entry except topical applications, inhaled sprays, eye drops
             or local injections.

          -  Uncontrolled diabetes mellitus as defined by HbA1c >7% despite adequate therapy.