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NCT03359954 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer
A Phase 2 study of Invasive Breast Carcinoma and HER2/Neu Negative, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT03359954: Active Phase 2 study of Invasive Breast Carcinoma and HER2/Neu Negative, sponsored by M.D. Anderson Cancer Center.
NCT03359954 is a Phase 2 study of Invasive Breast Carcinoma and HER2/Neu Negative that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 25 participants, below the 485-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03359954, a Phase 2 study of Invasive Breast Carcinoma and HER2/Neu Negative, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Primary Outcome
With 20 patients, a 95% confidence interval for the mean difference between TIL measurements would extend 0.44\*s units from the mean (where "s" is the standard deviation of the TIL differences). If the differences are not normally distributed, researchers will report the median difference along with appropriate 95% confidence intervals. Appropriate graphs used to visualize the data.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- PROCEDURE Therapeutic Conventional Surgery
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What the registry record for NCT03359954 still lists
NCT03359954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 485-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT03359954 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03359954 about?
NCT03359954 is a clinical study titled "Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer". This phase II trial studies how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy before surgery may make the tumor sm...
What is the current status of trial NCT03359954?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2017-11-16. Estimated completion is 2027-10-31.
What conditions does trial NCT03359954 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, HER2/Neu Negative, Estrogen Receptor Positive, Progesterone Receptor Positive.
What interventions are being tested in trial NCT03359954?
The interventions under investigation include: Radiation Therapy (RADIATION), Therapeutic Conventional Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03359954?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03359954 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive Breast Carcinoma
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 NCT03359954's enrollment target sits among peer trials
25 43rd of 45 higher than 3 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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