Overview

Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer

Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
Female
Summary
This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborators:
Novartis Pharmaceuticals
Tracon Pharmaceuticals Inc.
Treatments:
Antibodies, Monoclonal
Everolimus
Hormones
Letrozole
Sirolimus
Criteria
Inclusion Criteria:

- Recent diagnosis of hormone receptor positive and HER2 negative breast cancer.

- Stage 2 and 3 hormone receptor positive and HER2 negative breast cancer (stage T2-4
but not inflammatory, N0-2, M0).

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

- No prior treatment specific for breast cancer.

- Postmenopausal status as defined by the National Comprehensive Cancer Network.

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

- Must have signed study-specific informed consent.

- Liver Function Tests < 2.5 times the upper normal limit (UNL).

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

- Renal function: serum creatinine < 1.5 institutional UNL or creatinine clearance > 40
cc/min.

Exclusion Criteria:

- Inflammatory breast cancer.

- Pre- and peri-menopausal state.

- Pregnancy.

- Metastatic disease.

- HER2 positive breast cancer by immunohistochemistry or FISH.

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

- Disease that cannot be followed by imaging studies.