Letrozole + Everolimus + TRC105 for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Erica Stringer-Reasor, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment using three drugs together to treat a specific type of breast cancer in postmenopausal women before surgery. The drugs work by blocking hormones, growth signals, and blood supply to the tumor. The trial involves the use of advanced medications that have been introduced as effective treatments for postmenopausal women with this type of breast cancer.

Eligibility Criteria

This trial is for postmenopausal women with Stage 2 or 3 hormone receptor-positive and HER2-negative breast cancer, who haven't had treatment for it yet. They should be relatively healthy (ECOG < 2), have good blood counts and liver/renal function, and must consent to the study.

Inclusion Criteria

ANC ≥ 1,500/mm3, platelets ≥ 100,000/mm3, Hemoglobin ≥ 10g%.

Histological grade I, II or III according to the modified Bloom Richardson scale.

ECOG performance status < 2 (Karnofsky > 60%).

Exclusion Criteria

Metastatic disease.

Triple negative breast cancer (hormone receptor and Her2 negative).

Disease that cannot be followed by imaging studies.

Participant Groups

The trial tests a new drug combo: Letrozole (blocks estrogen receptors), Everolimus (stops cancer growth signals), and TRC105 (prevents blood vessel growth in tumors). It aims to see if this mix can safely improve outcomes before surgery.

Group I: Phase II Experimental Treatment 3 Interventions

Letrozole 2.5 mg PO daily until surgery, everolimus 5 or 10 mg PO daily for 24 weeks, and TRC105 15 or 10 mg/kg IV q 2 weeks for 24 weeks. Dose and regimen to be determined based on data from the phase I component.

Group II: Phase I Cohort 2 Experimental Treatment 3 Interventions

Letrozole 2.5 mg PO daily until surgery, everolimus 10 mg PO daily for 24 weeks, and TRC105 15 mg/kg IV q 2 weeks for 24 weeks

Group III: Phase I Cohort 1 Experimental Treatment 3 Interventions

Letrozole 2.5 mg PO daily until surgery, everolimus 5 mg PO daily for 24 weeks, and TRC105 15 mg/kg IV q 2 weeks for 24 weeks

Group IV: Phase I Cohort -1 Experimental Treatment 3 Interventions

Letrozole 2.5 mg PO daily until surgery, everolimus 5 mg PO daily for 24 weeks, and TRC105 10 mg/kg IV q 2 weeks for 24 weeks

Everolimus is already approved in United States, European Union, United States for the following indications:

🇺🇸 Approved in United States as Afinitor for:

• Advanced renal cell carcinoma
• Subependymal giant cell astrocytoma
• Progressive neuroendocrine tumors of pancreatic origin
• Advanced hormone receptor-positive, HER2-negative breast cancer
• Tuberous sclerosis complex-associated partial-onset seizures

🇪🇺 Approved in European Union as Votubia for:

• Subependymal giant cell astrocytoma
• Renal angiomyolipoma
• Tuberous sclerosis complex-associated partial-onset seizures

🇺🇸 Approved in United States as Zortress for:

• Prevention of organ rejection in kidney transplant patients

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alabama at Birmingham Birmingham, AL

Who Is Running the Clinical Trial?

University of Alabama at Birmingham Lead Sponsor

Tracon Pharmaceuticals Inc. Industry Sponsor

Novartis Pharmaceuticals Industry Sponsor

References