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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03176238 |
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Date of registration:
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01/06/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
EVEREXES |
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Scientific title:
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A Phase IIIb, Multi-center, Open-label Study of RAD001 in Combination With EXemestane in Post-menopausal Women With EStrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced or Metastatic Breast Cancer |
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Date of first enrolment:
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March 29, 2013 |
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Target sample size:
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235 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03176238 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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India
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Indonesia
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Jordan
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Korea, Republic of
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Malaysia
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Morocco
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South Africa
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Taiwan
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Thailand
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Tunisia
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Turkey
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Vietnam
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not
amenable to curative treatment by surgery or radiotherapy.
- Histological or cytological confirmation of hormone-receptor positive (HR+) breast
cancer.
- Disease refractory to non-steroidal aromatase inhibitors, defined as:
- Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy
with letrozole or anastrozole, or
- Progression while on, or within one month (30 days) of completion of letrozole or
anastrozole treatment for locally advanced or metastatic breast cancer (ABC).
- Radiological or objective evidence of recurrence or progression on or after the last
systemic therapy prior to enrolment.
- Patients must have had:
- At least one lesion that could have been accurately measured in at least one dimension
- 20 mm with conventional imaging techniques or = 10 mm with spiral CT or MRI, or
- Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as
defined above.
- Adequate bone marrow, coagulation, liver and renal function.
- ECOG performance status = 2.
Exclusion Criteria:
- Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ
hybridization positive). Patients with IHC 2+ must have a negative in situ
hybridization test.
- Patients with only non-measurable lesions other than bone metastasis (e.g. pleural
effusion, ascites).
- Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an
anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given
for a minimum of 21 days.
- Previous treatment with mTOR inhibitors.
- Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).
- Patients with a known history of HIV seropositivity. Screening for HIV infection at
baseline was not required.
- Patient who were being treated with drugs recognized as being strong inhibitors or
inducers of the isoenzyme CYP3A
- History of brain or other CNS metastases, including leptomeningeal metastasis.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Post Menopausal Breast Cancer
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Intervention(s)
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Drug: everolimus
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Drug: exemestane
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Primary Outcome(s)
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Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
[Time Frame: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period]
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Secondary Outcome(s)
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Progression Free Survival (PFS)
[Time Frame: Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries]
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Percentage of Participants Clinical Benefit Rate
[Time Frame: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries]
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Percentage of Participants Response Rates (Best Overall and Overall)
[Time Frame: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries]
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Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
[Time Frame: Baseline up to approximately 50 weeks]
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Secondary ID(s)
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CRAD001JIC06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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