Study on Letrozole, Everolimus, and TRC105 for Postmenopausal Women with Certain Types of Breast Cancer

Sponsor: University of Alabama at Birmingham

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02520063

Provider View

This clinical trial is testing a new combination of three drugs to see if they are safe and effective in treating Stage 2 and 3 breast cancer in postmenopausal women. The drugs work by blocking hormones, growth signals, and blood vessels that help cancer grow.

Patient Parameters

Program Overview

The study aims to find out if a combination of three drugs—Letrozole, Everolimus, and TRC105—can be safely used and effectively shrink tumors in postmenopausal women with Stage 2 and 3 hormone-receptor positive and HER2 negative breast cancer before surgery. Letrozole stops the cancer from using estrogen, Everolimus blocks signals that help cancer cells grow, and TRC105 is an experimental drug that prevents new blood vessels from forming around the tumor.

Description

This study focuses on postmenopausal women with a specific type of breast cancer that is hormone receptor-positive and HER2 negative. The goal is to reduce the size of the tumor before surgery, which can lower the risk of the cancer coming back. The treatment combines three drugs: Letrozole, which reduces estrogen levels that fuel cancer growth; Everolimus, which blocks growth signals in cancer cells; and TRC105, an investigational drug that stops new blood vessels from forming around the tumor, cutting off its supply of oxygen and nutrients.

The study has two parts. First, researchers will find the best dose combination of the three drugs that patients can tolerate. Once this is determined, more patients will receive this combination to see how well it works in shrinking the tumors. This will provide early insights into the effectiveness of the treatment, but more research will be needed to confirm the results.

Eligibility Criteria

Inclusion Criteria

  • Recently diagnosed with hormone receptor-positive and HER2 negative breast cancer.
  • Have Stage 2 or 3 breast cancer (tumor size T2-4, not inflammatory, lymph nodes N0-2, no metastasis M0).
  • Cancer graded I, II, or III based on specific criteria.
  • No previous treatment for breast cancer.
  • Must be postmenopausal as defined by medical guidelines.
  • In good general health with an ECOG performance status of less than 2.
  • Must agree to participate and sign a consent form.
  • Liver function tests must be less than 2.5 times the normal limit.
  • Blood counts and kidney function must meet specific levels.

Exclusion Criteria

  • Have inflammatory breast cancer.
  • Are premenopausal or perimenopausal.
  • Are pregnant.
  • Have cancer that has spread to other parts of the body.
  • Have HER2 positive breast cancer.
  • Have triple negative breast cancer.
  • Have cancer that cannot be monitored with imaging tests.

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