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NCT01468883 · ClinicalTrials.gov registry record · Phase 3
The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection Versus Excisional Biopsy, Axillary Dissection, and Definitive Irradiation
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 256
- Enrollment target
NCT01468883: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT01468883 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 256 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468883, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 256 participants
- Enrollment target
Study Summary
Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation. Data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. This study will test this hypothesis in a prospective, randomized manner. After primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.
Primary Outcome
To compare the results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy
Interventions
- PROCEDURE M
- RADIATION X
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 1979-09-04 |
| Est. Completion | 2016-11-17 |
| Phase | Phase 3 |
What the finished NCT01468883 record still lists
NCT01468883 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which M is the first listed.
NCT01468883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01468883 about?
NCT01468883 is a clinical study titled "The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection Versus Excisional Biopsy, Axillary Dissection, and Definitive Irradiation". Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation. Data from single institutions and from retrospe...
What is the current status of trial NCT01468883?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 1979-09-04. Estimated completion is 2016-11-17.
What interventions are being tested in trial NCT01468883?
The interventions under investigation include: M (PROCEDURE), X (RADIATION).
Who is sponsoring clinical trial NCT01468883?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01468883's enrollment target sits among peer trials
256 1240th of 2000 higher than 759 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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