EMERALD: Study on Using Only Radiation Therapy After Surgery in ER+ Breast Cancer for Women Aged 60 and Older

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06897488

Provider View

This study is exploring the effects of using only radiation therapy, without hormone therapy, after surgery in women aged 60 and older with early-stage, low-risk breast cancer. The focus is on understanding how this approach affects quality of life and disease control.

Patient Parameters

Program Overview

The purpose of this study is to see how well radiation therapy alone works after surgery in women aged 60 and older who have early-stage, low-risk breast cancer. Researchers want to learn about the quality of life and how well the cancer is controlled without using hormone therapy.

Description

The main goal of this study is to find out how effective radiation therapy alone is in preventing cancer from spreading to other parts of the body over three years in women aged 60 and older with early-stage, low-risk breast cancer.

Other goals include:

  • Understanding the quality of life for these women when they receive only radiation therapy after surgery.
  • Checking the risk of cancer returning in the same breast within three and five years after treatment.
  • Measuring the rates of cancer returning in nearby areas, new cancer in the other breast, survival specific to breast cancer, overall survival, and cancer spread over three and five years.
  • Looking at the use of additional surgeries or treatments if cancer returns within five years.
  • Collecting long-term data on cancer outcomes up to 11 years later through medical records or phone calls.
  • Identifying any side effects experienced by women aged 60 and older receiving only radiation therapy after surgery.

Eligibility Criteria

Inclusion Criteria

  • Women aged 60 or older with a confirmed diagnosis of invasive breast cancer.
  • Have undergone breast-conserving surgery.
  • Tumor size is 3 cm or smaller, including any non-invasive components.
  • Tumor cells show low activity (Ki-67 ≤ 20%).
  • Clear surgical margins, meaning no cancer cells at the edge of the removed tissue.
  • Tumor is positive for estrogen and progesterone receptors and does not have an excess of HER2 protein.
  • No cancer detected in lymph nodes.
  • Have discussed or will discuss additional treatment options with a breast cancer specialist.

Exclusion Criteria

  • Cancer has spread to lymph nodes or other parts of the body.
  • High-grade tumors with certain aggressive features.
  • Cancer in both breasts at the same time.
  • Have received treatment before surgery.
  • Have certain autoimmune diseases that increase the risk of radiation side effects.
  • Have had another cancer in the past five years, except for certain skin cancers.
  • Have mental health or social issues that could affect participation in the study.
  • Have had radiation therapy to the same breast before or have recurrent breast cancer.
  • Known genetic mutations that increase the risk of breast cancer, like BRCA1 or BRCA2.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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