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

A Randomized, Double-blind, Placebo Controlled, Phase II Study of Everolimus in Combination With Exemestane in the Treatment of Chinese Postmenopausal Women With Estrogen Receptor Positive, HER-2 Negative, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole

ClinicalTrials.gov Identifier: NCT03312738

Novartis Reference Number: CRAD001Y2202

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study aims at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- ABC after recurrence or progression on letrozole or anastrozole.

The rationale of this study is based on the following:

Proven everolimus activity in breast cancer in combination with exemestane
Efficacy and manageable safety profile of everolimus in combination with exemestane in the Asian subpopulation of BOLERO-2

Condition 
Advanced Breast Cancer
Phase 
Phase 2
Overall status 
Active, not recruiting
Enrollment count 
159 participants
Start date 
Sep 15, 2017
Completion date 
Apr 29, 2022
Gender 
Female
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Everolimus
Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) are administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.
Drug
Exemestane
Exemestane 25 mg orally daily.
Drug
Everolimus Placebo
Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) are administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.

Eligibility Criteria

Inclusion Criteria:

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 is 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 is 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 must have as per RECIST 1.1

• measurable disease or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease.

8. Patient is able to swallow and retain oral medication 9. Patient must meet the hematologic & biochemistery laboratory values at the screening visit:

Written informed consent must be obtained prior to any screening procedures

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria:
HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive), based on the most recent test. Note: Patients with IHC 2+ must have a negative in situ hybridization test.
Patients who received more than one chemotherapy line for ABC
Patient with symptomatic visceral disease and is candidate 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 use 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.

Other protocol-defined inclusion/exclusion criteria may apply"

Study Locations

China
Novartis Investigative Site
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Guangzhou, 510000
Guangdong
China
Novartis Investigative Site
-
Harbin, 150081
Heilongjiang
China
Novartis Investigative Site
-
Wuhan, 430022
Hubei
China
Novartis Investigative Site
-
Nanjing, 210009
Jiangsu
China
Novartis Investigative Site
-
Shanghai, 200032
Shanghai
China
Novartis Investigative Site
-
Chengdu, 610041
Sichuan
China
Novartis Investigative Site
-
Chengdu, 610072
Sichuan
China
Novartis Investigative Site
-
Tianjin, 300060
Tianjin
China
Novartis Investigative Site
-
Hangzhou, 310022
Zhejiang
China
Novartis Investigative Site
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Beijing, 100036
-
China
Novartis Investigative Site
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Chongqing, 400016
-
China
Novartis Investigative Site
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Guangzhou, 510060
-
China
Novartis Investigative Site
-
Qingdao, 266000
-
China
Novartis Investigative Site
-
Shanghai, 200025
-
China
Novartis Investigative Site
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Wuhan, 430000
-
China

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