Purpose

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.

Category

IRB Number
20140060HU
NCT Number
NCT01674140
Open to Enrollment
Yes
Sponsor
Southwest Oncology Group -



Study Contact

Principal Investigator
Kate Lathrop

Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Kate Lathrop
(210) 450-1420
lathrop@uthscsa.edu

Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Staff
regaffstaff@uthscsa.edu

Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 3
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      Double (Participant, Investigator)
      Condition
    1. Breast Cancer

      2. Arm Groups

      ArmDescriptionIntervention
      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.
    2. Drug: everolimus

      Given PO

      Other names:

      • Afinitor

    3. Drug: goserelin acetate

      Given subcutaneously or intramuscularly

      Other names:

      • Zoladex

    4. Drug: leuprolide acetate

      Given subcutaneously or intramuscularly

      Other names:

      • Lupron

    5. Other: placebo

      Given PO

    6. Drug: anastrozole

      Given orally

      Other names:

      • Arimidex

    7. Drug: exemestane

      Given orally

      Other names:

      • Aromasin

    8. Drug: letrozole

      Given orally

      Other names:

      • Femara

    9. Drug: tamoxifen citrate

      Given PO

      Other names:

      • nolvadex

      10. 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.
    10. Drug: everolimus

      Given PO

      Other names:

      • Afinitor

    11. Drug: goserelin acetate

      Given subcutaneously or intramuscularly

      Other names:

      • Zoladex

    12. Drug: leuprolide acetate

      Given subcutaneously or intramuscularly

      Other names:

      • Lupron

    13. Drug: anastrozole

      Given orally

      Other names:

      • Arimidex

    14. Drug: exemestane

      Given orally

      Other names:

      • Aromasin

    15. Drug: letrozole

      Given orally

      Other names:

      • Femara

    16. Drug: tamoxifen citrate

      Given PO

      Other names:

      • nolvadex

      17.