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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03176238




Registration number
NCT03176238
Ethics application status
Date submitted
1/06/2017
Date registered
5/06/2017

Titles & IDs
Public title
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Scientific title
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
Secondary ID [1] 0 0
CRAD001JIC06
Universal Trial Number (UTN)
Trial acronym
EVEREXES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Menopausal Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - everolimus
Treatment: Drugs - exemestane

Experimental: everolimus + exemestane - Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily


Treatment: Drugs: everolimus
one 10 mg tablet or two 5 mg tablets of everolimus were administered orally once daily on a continuous dosing schedule starting on Day 1

Treatment: Drugs: exemestane
25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
Timepoint [1] 0 0
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
Secondary outcome [1] 0 0
Percentage of Participants Response Rates (Best Overall and Overall)
Timepoint [1] 0 0
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Secondary outcome [2] 0 0
Percentage of Participants Clinical Benefit Rate
Timepoint [2] 0 0
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries
Secondary outcome [4] 0 0
Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
Timepoint [4] 0 0
Baseline up to approximately 50 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/01/2019
Sample size
Target
Accrual to date
Final
235
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Garran
Recruitment hospital [2] 0 0
Novartis Investigative Site - Caringbah
Recruitment hospital [3] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [4] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [5] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [6] 0 0
Novartis Investigative Site - Ringwood East
Recruitment hospital [7] 0 0
Novartis Investigative Site - St Albans
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2229 - Caringbah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3135 - Ringwood East
Recruitment postcode(s) [7] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Gujarat
Country [2] 0 0
India
State/province [2] 0 0
Maharashtra
Country [3] 0 0
India
State/province [3] 0 0
Orissa
Country [4] 0 0
Indonesia
State/province [4] 0 0
Bandung
Country [5] 0 0
Indonesia
State/province [5] 0 0
Jakarta
Country [6] 0 0
Indonesia
State/province [6] 0 0
Jogyakarta
Country [7] 0 0
Indonesia
State/province [7] 0 0
Semarang
Country [8] 0 0
Jordan
State/province [8] 0 0
Amman
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Gyeonggi-do
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Korea
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seocho Gu
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Busan
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Jeollanam-do
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Taegu
Country [16] 0 0
Malaysia
State/province [16] 0 0
MYS
Country [17] 0 0
Malaysia
State/province [17] 0 0
Sabah
Country [18] 0 0
Malaysia
State/province [18] 0 0
Wilayah Persekutuan
Country [19] 0 0
Morocco
State/province [19] 0 0
Casablanca
Country [20] 0 0
Morocco
State/province [20] 0 0
Rabat
Country [21] 0 0
South Africa
State/province [21] 0 0
Western Cape
Country [22] 0 0
Taiwan
State/province [22] 0 0
TWN
Country [23] 0 0
Taiwan
State/province [23] 0 0
Changhua
Country [24] 0 0
Taiwan
State/province [24] 0 0
Kaohsiung City
Country [25] 0 0
Taiwan
State/province [25] 0 0
Kaoshiung
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei
Country [27] 0 0
Thailand
State/province [27] 0 0
Bangkok
Country [28] 0 0
Thailand
State/province [28] 0 0
Chiang Mai
Country [29] 0 0
Tunisia
State/province [29] 0 0
Ariana
Country [30] 0 0
Turkey
State/province [30] 0 0
Ankara
Country [31] 0 0
Turkey
State/province [31] 0 0
Gaziantep
Country [32] 0 0
Turkey
State/province [32] 0 0
Izmir
Country [33] 0 0
Turkey
State/province [33] 0 0
Kartal
Country [34] 0 0
Turkey
State/province [34] 0 0
Pendik / Istanbul
Country [35] 0 0
Vietnam
State/province [35] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03176238