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NCT01272037 · ClinicalTrials.gov registry record · Phase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
A Phase 3 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 5,018
- Enrollment target
- 20
- Study locations
NCT01272037: Active Phase 3 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ, sponsored by National Cancer Institute (NCI).
NCT01272037 is a Phase 3 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 5,018 participants, above the 374-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (1242% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01272037, a Phase 3 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 5,018 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer 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. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.
Primary Outcome
From date of randomization (2nd Registration) to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. This is the STEEP definition of invasive disease-free survival. Kaplan-Meier estimates were calculated for the 5-year IDFS rate. Due to the results of the third prespecified int
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Alabama
- Northeast Alabama Regional Medical Center - Anniston
- University of Alabama at Birmingham Cancer Center - Birmingham
- Providence Hospital - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- NEA Baptist Memorial Hospital - Jonesboro
Arizona
- Virginia G Piper Cancer Care-Del Camino - Scottsdale
California
- Kaiser Permanente-Anaheim - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,018 participants |
| Start Date | 2011-02-28 |
| Est. Completion | 2027-01-08 |
| Phase | Phase 3 |
What the registry record for NCT01272037 still lists
NCT01272037 is an interventional study that assigns participants to a tested intervention. Its 5,018 participants enrollment target places it among the larger protocols in the corpus, above the 374-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (1242% higher).
The record links to 5 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01272037 names 20 study sites across 5 states, led by Alaska, Alabama, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01272037 about?
NCT01272037 is a clinical study titled "Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer". This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause t...
What is the current status of trial NCT01272037?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 5,018 participants. The study started on 2011-02-28. Estimated completion is 2027-01-08.
What conditions does trial NCT01272037 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Breast Ductal Carcinoma In Situ, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma, Synchronous Bilateral Breast Carcinoma.
What interventions are being tested in trial NCT01272037?
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 NCT01272037?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01272037 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01272037's enrollment target sits among peer trials
5,018 1st of 45 higher than 45 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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