Study on Hormone Therapy With or Without Chemotherapy for Women After Surgery for Node-Negative Breast Cancer (TAILORx Trial)
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00310180
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.
Patient Parameters
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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 breast cancer growth. Chemotherapy uses drugs to kill or stop the growth of cancer cells. The trial seeks to understand if adding chemotherapy to hormone therapy significantly reduces cancer recurrence for these patients.
Description
The main goal of this study is to see if hormone therapy alone is as effective as hormone therapy combined with chemotherapy for women with certain breast cancer scores. The study will also collect tissue samples to help understand more about breast cancer.
Secondary goals include checking if hormone therapy alone is enough for women with lower cancer scores and comparing different methods of predicting cancer outcomes. The study will also look at how the Oncotype DX test score relates to the effectiveness of chemotherapy.
The study will also explore how treatments affect patients' quality of life, including cognitive function, fatigue, and fear of cancer returning. It will examine if these effects differ between those receiving hormone therapy alone and those receiving both treatments.
Participants will be divided into groups based on their Oncotype DX scores:
- Group 1: Women with scores 10 or below will receive hormone therapy.
- Group 2: Women with scores 11-25 will be randomly assigned to receive either hormone therapy alone or with chemotherapy.
- Group 3: Women with scores 26 or above will receive both chemotherapy and hormone therapy.
All participants who had breast-conserving surgery will also receive radiotherapy. After treatment, patients will have regular follow-ups for up to 20 years to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Women with breast cancer that can be surgically removed and has been confirmed by lab tests.
- Cancer must be 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 breast cancer must be available for testing.
- Adequate blood cell counts and organ function.
- No other invasive cancers in the past 5 years, except for 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 must use effective contraception if of childbearing potential.
- Must not have had the Oncotype DX test before, unless the score is 11-25.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northeast Alabama Regional Medical Center | 36202 | Anniston | Alabama |
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Mobile Infirmary Medical Center | 36607 | Mobile | Alabama |
| Providence Hospital | 36608 | Mobile | Alabama |
| University of South Alabama Mitchell Cancer Institute | 36688 | Mobile | Alabama |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Banner Thunderbird Medical Center | 85306 | Glendale | Arizona |
| Banner Desert Medical Center | 85202 | Mesa | Arizona |
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