Study on Hormone Therapy With or Without Chemotherapy for Women After Surgery for Node-Negative Breast Cancer (TAILORx Trial)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT00310180

Provider View

This clinical trial is exploring whether hormone therapy alone or combined with chemotherapy is more effective for women with node-negative, estrogen-receptor positive breast cancer. The study uses a special test called Oncotype DX to help decide the best treatment approach based on the cancer's recurrence score.

Patient Parameters

Program Overview

The TAILORx trial aims to find the best treatment for women with node-negative, estrogen-receptor positive breast cancer. It uses the Oncotype DX test to determine if hormone therapy alone or with chemotherapy is more beneficial for women with a recurrence score of 11-25. Hormone therapy works by blocking or reducing estrogen, which can fuel cancer growth. Chemotherapy uses drugs to kill or stop the growth of cancer cells. This study seeks to understand if adding chemotherapy to hormone therapy significantly reduces cancer recurrence.

Description

The TAILORx trial is designed to determine the most effective treatment for women with node-negative, estrogen-receptor positive breast cancer. The study uses the Oncotype DX test to assess the likelihood of cancer recurrence and guide treatment decisions. Women with a recurrence score of 11-25 are randomly assigned to receive either hormone therapy alone or in combination with chemotherapy. Hormone therapy helps fight cancer by blocking estrogen, while chemotherapy targets cancer cells to stop their growth or spread.

The trial also aims to create a bank of tissue and blood samples for future research. It will evaluate the effectiveness of hormone therapy alone for women with a recurrence score of 10 or less and compare outcomes predicted by traditional methods with those from the Oncotype DX test. Additionally, the study will explore the impact of treatment on quality of life, including cognitive function, fatigue, and fear of recurrence.

Participants are divided into three groups based on their Oncotype DX recurrence score:

  • Group 1 (Score ≤ 10): Receive standard hormone therapy for 5 or 10 years.
  • Group 2 (Score 11-25): Randomly receive either hormone therapy alone or with chemotherapy.
  • Group 3 (Score ≥ 26): Receive combination chemotherapy followed by hormone therapy.

All participants who had breast-conserving surgery will also receive radiotherapy. Follow-up visits occur every 3-6 months for 5 years, then annually for 15 years.

Eligibility Criteria

Inclusion Criteria

  • Women with operable breast cancer that is estrogen and/or progesterone receptor positive.
  • Cancer must not have spread to lymph nodes.
  • Tumor size between 1.1-5.0 cm, or 5 mm-1.0 cm with certain unfavorable features.
  • Tumor must be HER2/neu negative.
  • Willing to start standard chemotherapy and hormone therapy.
  • Tissue sample from the primary tumor must be available for testing.
  • Adequate blood cell counts and organ function.
  • No prior invasive cancer for at least 5 years, except certain skin cancers or cervical carcinoma in situ.
  • Must have completed surgery within 84 days before joining the study.
  • No prior chemotherapy or radiation for this cancer.
  • Must not be pregnant or breastfeeding and agree to use effective contraception if of childbearing potential.
  • Must not have had the Oncotype DX test before, unless the score is 11-25.

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