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Everolimus

Exemestane

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Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily

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

everolimus

25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1

exemestane

Novartis Pharmaceuticals

This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.

Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

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

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

Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.

The best overall response for each patient is determined from the sequence of investigator overall lesion responses according to RECIST 1.1: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was \>=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was \>=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. To be assigned a best overall response of CR at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best overall response of PR at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method

Clinical benefit rate: Patients with best overall response rate of CR (any duration), PR (any duration) and SD with duration of 24 weeks or longer according to RECIST 1.1 criteria: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was \>=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was \>=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. Best overall response of CR = at least two determinations of CR at least 4 weeks apart before progression are required. Best overall response of PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method.

PFS is time from date of start of treatment to date of disease progression or death due to any cause, whichever occurs first.

b Percentiles with 95% CIs are calculated from PROC LIFETEST output using method of Brookmeyer and Crowley (1982)

Time to deterioration of ECOG performance status, from baseline will be assessed using the ECOG Performance Status Scale (Oken, 1982). Time to deterioration is the time from date of start of treatment to the date of the event defined as deterioration. Deterioration is defined as an increase in performance status from 0 to 2 or greater, an increase in performance status from 1-2 to 3 or greater, or death due to any cause. Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Event-free probability estimates were are obtained from the Kaplan-Meier survival estimates.

Any sign or symptom that occurs during the study treatment plus the 30 days post treatment

Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.

Asian

Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.

Non-Asian

Everolimus (10 Mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.

Asian Everolimus + Exemestane

Non-Asian Everolimus + Exemestane

Total

Age, Continuous

Females

Sex/Gender, Customized

Caucasian

Other

Race/Ethnicity, Customized

Study Director

no TEAE

at least 1 TEAE

at least 1 drug-related TEAE

at least 1 serious TEAE (STEAE)

STEAE leading to death

Non-fatal STEAE

at least 1 drug-related STEAE

at least 1 drug-related STEAE - death

at least 1 drug-related non-fatal STEAE

TEAE leading to permanent tx discontinuation

1 TE AESI

Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades

Complete response (CR)

Partial response (PR)

Stable disease (SD)

Progressive disease (PD)

Unknown (UNK)

Overall response rate (ORR: CR+PR)

Percentage of Participants Response Rates (Best Overall and Overall)

Percentage of Participants Clinical Benefit Rate

Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan

Asian Everolimus and Exemestane

Progression Free Survival (PFS)

Week 0 n=199,36,235

Week 20 n=134,18,152

Week 50 n=58,7,65

Number of participants meeting criteria differed at visits

Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer	NCT03176238	Post Menopausal...	everolimus exemestane	18 Years -	Novartis
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer	NCT03176238	Post Menopausal...	everolimus exemestane	18 Years -	Novartis
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer	NCT03176238	Post Menopausal...	everolimus exemestane	18 Years -	Novartis

Spots Global Cancer Trial Database for human epidermal growth factor