Testing Low Dose Tamoxifen for Treating Early Stage Breast Cancer in Post-Menopausal Women

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06671912

Provider View

This study is comparing the effects of low dose tamoxifen with usual hormone therapies, like aromatase inhibitors, in post-menopausal women with early stage hormone-positive, HER2 negative breast cancer. The goal is to see if low dose tamoxifen is as effective as standard treatments in preventing cancer recurrence.

Patient Parameters

Program Overview

This phase III trial is investigating whether low dose tamoxifen can be as effective as standard hormone therapies, such as aromatase inhibitors, in treating post-menopausal women with early stage hormone-positive, HER2 negative breast cancer. Tamoxifen works by blocking estrogen in the breast, which may stop the growth of tumors that need estrogen to grow. Aromatase inhibitors, like anastrozole, letrozole, and exemestane, work by preventing the formation of estrogen. The study aims to determine if low dose tamoxifen can be a better option for these patients.

Description

The study has several goals:

Primary Goal:

  • To see if low-dose tamoxifen is as effective as standard hormone therapy in preventing cancer from coming back in post-menopausal women with early-stage, low-risk breast cancer.

Secondary Goals:

  • To compare how well patients stick to their hormone therapy in each group.
  • To compare side effects like osteoporosis, fractures, uterine cancer, stroke, and blood clots between the two groups.
  • To compare patient-reported symptoms related to hormone therapy.
  • To compare how long patients remain free of invasive disease in each group.
  • To compare local and distant cancer recurrence rates between the groups.
  • To compare overall survival rates between the groups.
  • To compare the occurrence of ductal carcinoma in situ (DCIS) between the groups.
  • To explore the impact of different radiation treatments on recurrence-free intervals.
  • To assess quality of life and reasons for not sticking to treatment.
  • To compare changes in breast density on mammograms after two years.
  • To compare different methods of measuring breast density.

Study Design:

  • Participants are randomly assigned to one of two groups.
  • Group 1: Standard hormone therapy (anastrozole, letrozole, exemestane, or standard dose tamoxifen) taken daily for up to 5 years.
  • Group 2: Low-dose tamoxifen taken every other day for up to 5 years.
  • Participants may have mammograms, MRIs, bone density scans, and blood tests during the study.
  • After treatment, participants will be followed for 10 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with invasive breast cancer that is estrogen receptor positive in at least 10% of cells and HER2 negative.
  • Have a low-risk score from a multigene test, such as Oncotype DX, Mamma Print, or Prosigna.
  • Tumor size must be 3 cm or smaller.
  • Have had surgery to remove all visible cancer with clear margins.
  • No evidence of cancer spread to lymph nodes or other parts of the body.
  • No suspicious findings in the other breast unless confirmed benign.
  • Must start the study within 20 weeks of surgery.
  • Must have had a mammogram or MRI within 6 months before starting the study.
  • Plan to take hormone therapy for at least 5 years.
  • No prior hormone or chemotherapy treatment for the current breast cancer.
  • No recent use of hormone replacement therapy.
  • Must be 18 years or older and postmenopausal.
  • Must not have certain uterine or blood clotting conditions that increase risk with tamoxifen.
  • No history of breast or chest radiation for other conditions.
  • No previous breast cancer in the same breast or any cancer in the other breast.
  • No other cancers that could interfere with the study.
  • Not premenopausal.
  • Not currently on hormone therapy for breast cancer prevention or osteoporosis.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.

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