Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 recur...
Detailed Description
This was a multicenter, double-blind, randomized, placebo-controlled, phase II study evaluating treatment with everolimus (10 mg daily) in combination with exemestane (25 mg daily) vs placebo in combi...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2022
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT03312738
Start Date
September 15 2017
End Date
April 25 2022
Last Update
January 23 2024
Active Locations (15)
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1
Novartis Investigative Site
Guangzhou, Guangdong, China, 510000
2
Novartis Investigative Site
Harbin, Heilongjiang, China, 150081
3
Novartis Investigative Site
Wuhan, Hubei, China, 430022
4
Novartis Investigative Site
Nanjing, Jiangsu, China, 210009