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Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
NCT00310180 · View on ClinicalTrials.gov ↗
Study Summary
This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
Study Locations (20)
Arizona
- Banner Thunderbird Medical Center — Glendale
- Banner Desert Medical Center — Mesa
- Banner Baywood Medical Center — Mesa
- Banner-University Medical Center Phoenix — Phoenix
- Western Regional CCOP — Phoenix
- Virginia G Piper Cancer Care-Del Camino — Scottsdale
- Banner University Medical Center - Tucson — Tucson
Alabama
- Northeast Alabama Regional Medical Center — Anniston
- University of Alabama at Birmingham Cancer Center — Birmingham
- Mobile Infirmary Medical Center — Mobile
- Providence Hospital — Mobile
- University of South Alabama Mitchell Cancer Institute — Mobile
Arkansas
- Sparks Regional Medical Center — Fort Smith
- Mercy Hospital Fort Smith — Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs
- NEA Baptist Memorial Hospital — Jonesboro
- Saint Bernards Regional Medical Center — Jonesboro
Alaska
- Alaska Regional Hospital — Anchorage
- Providence Alaska Medical Center — Anchorage
- Fairbanks Memorial Hospital — Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,273 participants |
| Start Date | 2006-04-07 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00310180
The ClinicalTrials.gov registry entry for NCT00310180 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10,273 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Breast Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions — of which Quality-of-Life Assessment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00310180 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Arizona, Alabama, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00310180 about?
NCT00310180 is a clinical study titled "Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)". This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who ha...
What is the current status of trial NCT00310180?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 10,273 participants. The study started on 2006-04-07. Estimated completion is 2030-09-30.
What conditions does trial NCT00310180 study?
This clinical trial studies the following conditions: Breast Adenocarcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IB Breast Cancer AJCC v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IA Breast Cancer AJCC v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00310180?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00310180?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00310180 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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