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NCT00310180 · ClinicalTrials.gov registry record · Phase 3
Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
A Phase 3 study of Breast Adenocarcinoma and Stage IIA Breast Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 10,273
- Enrollment target
- 20
- Study locations
NCT00310180 is a Phase 3 study of Breast Adenocarcinoma and Stage IIA Breast Cancer AJCC v6 and v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 10,273 participants, above the 461-participant average among 18 other Breast Adenocarcinoma trials with a reported enrollment target (2128% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT00310180, a Phase 3 study of Breast Adenocarcinoma and Stage IIA Breast Cancer AJCC v6 and v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 10,273 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 10,273 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 461-participant average among 18 other Breast Adenocarcinoma trials with a reported enrollment target (2128% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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.
NCT00310180 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Arizona, Alabama, Arkansas.
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.
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).
Who is sponsoring clinical trial NCT00310180?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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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