Phase II Study of Letrozole Therapy Before Surgery for ER+ Breast Cancer (NAOMI)

Sponsor: Dartmouth-Hitchcock Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04568616

Provider View

This clinical trial is testing the effects of the drug letrozole, given before surgery, in post-menopausal women with certain types of breast cancer. The study aims to understand how well this treatment works and how it affects cancer cells.

Patient Parameters

Program Overview

This study is exploring the use of letrozole, a medication that reduces estrogen levels, in post-menopausal women with Stage I-III estrogen receptor-positive (ER+), HER2-negative breast cancer. Participants will take letrozole for 4 to 24 weeks before having surgery to remove the tumor. Researchers will compare tumor samples taken before and after treatment to study the effects of letrozole on cancer cells. Some participants may also provide an extra tumor sample for research before starting treatment. The study will also look at how well participants stick to the treatment plan and gather feedback through surveys to understand any challenges they face.

Description

About 70% of breast cancers have estrogen receptors (ER), which help cancer cells grow. Letrozole is a type of drug called an aromatase inhibitor that lowers estrogen levels and is used to treat ER+ breast cancer. This study focuses on using letrozole before surgery to see if it can help shrink tumors and prevent cancer from coming back. Researchers are interested in understanding how letrozole affects cancer cells and why some cancers become resistant to treatment over time. Participants will take letrozole for a period before surgery, and their tumor samples will be analyzed to learn more about the cancer's behavior and response to treatment. The study will also collect information on how well participants follow the treatment plan and any issues they encounter.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of invasive breast cancer through a biopsy.
  • The cancer must be estrogen receptor-positive, with more than 50% of cancer cells showing ER presence.
  • The cancer must be HER2-negative.
  • Have Stage I-III breast cancer and plan to have surgery to remove the tumor. The tumor must be at least 0.5 cm in size.
  • Women with multiple tumors or cancer in both breasts can participate if they are suitable for hormone therapy before surgery.
  • Be a post-menopausal woman over 18 years old, with no menstrual period for over 2 years or over 1 year with specific hormone levels.
  • Meet certain blood test criteria, including adequate white blood cell and platelet counts, and normal liver function tests.
  • Be able to provide informed consent to participate in the study.

Exclusion Criteria

  • Have received hormone therapy for any cancer or to prevent breast cancer in the last 10 years.
  • Have had any other treatment before surgery for breast cancer, except for bone-strengthening treatments like bisphosphonates or denosumab.
  • Be pregnant or breastfeeding.

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