Invasive Disease-Free Survival (IDFS)
| Group | Value (percentage of participants) |
|---|---|
| Placebo | 74.4 |
| Everolimus | 74.9 |
Trial · Interventional
Active, not recruitingPhase 3Results postedRegistry dataShort name e3
United States, Puerto Rico
1 trial · 1 ongoing · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
Placebo comparator
Arm I
Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or an aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
Experimental
Arm II
Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
Outcomes the sponsor listed as primary.
Invasive Disease-Free Survival (IDFS)
Time frame · Up to 5 years post registration
Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. The results were presented as 5-year IDFS estimate.
Overall Survival (OS)
Time frame · 5 years after last accrual
Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The results were presented as 5-year OS estimate.
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Time frame · Every 6 weeks while on protocol therapy. Adverse events (AEs) that occurred during follow up after protocol treatment were reported as late AEs, for every 6 months for the first 2 years and then yearly until 10 years after registration.
Toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only adverse events that are possibly, probably, or definitely related to study drug are reported.
Distant Recurrence-Free Survival (DRFS)
Time frame · 5 years after last accrual
Time from date of registration to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Patients last known to be alive who have not experienced distant recurrence, or second primary cancer are censored at their last contact date. The results were presented as 5-year DRFS estimate.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Placebo | 74.4 |
| Everolimus | 74.9 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo | 85.8 |
| Everolimus | 88.1 |
| Group | Value (Participants) |
|---|---|
| Placebo | 1 |
| Everolimus | 7 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo | 75.7 |
| Everolimus | 76.9 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboPatients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity. NOTE: \*Men receive tamoxifen citrate PO for 5 years. NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal. | 119 / 896 | 77 / 881 | 798 / 881 |
| EverolimusPatients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity. | 112 / 896 | 180 / 874 | 842 / 874 |
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