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NCT02945579 · ClinicalTrials.gov registry record · NA
Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
A NA study of Invasive Breast Carcinoma and HER2/Neu Negative, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 8
- Study locations
NCT02945579: Recruiting NA study of Invasive Breast Carcinoma and HER2/Neu Negative, sponsored by M.D. Anderson Cancer Center.
NCT02945579 is a NA study of Invasive Breast Carcinoma and HER2/Neu Negative that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 120 participants, below the 482-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (75% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02945579, a NA study of Invasive Breast Carcinoma and HER2/Neu Negative, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 8
- Study locations
Study Summary
This clinical trial studies eliminating surgery and/or radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual cancer, patients then receive standard breast radiotherapy with no surgery. In ER positive/HER2 negative breast cancers, after endocrine therapy and ablative radiotherapy, when image-guided biopsy shows no residual cancer, patients then receive standard endocrine therapy with no surgery. For patients who have HER2 positive and triple negative breast cancers and standard surgery, after systemic therapy, breast radiotherapy is being eliminated when the pathology from surgery shows no residual cancer.
Primary Outcome
Will monitor IBT-RFS using the method of Thall et al. Will be estimated using the Kaplan-Meier method log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- RADIATION Undergo EBRT
- RADIATION Partial Breast Irradiation
Study Locations (8)
Arizona
- MD Anderson Cancer Center - Banner - Gilbert
Florida
- Baptist MD Anderson Cancer Center - Jacksonville
Hawaii
- Queen's Medical Center - Honolulu
Minnesota
- Mayo Clinic - Rochester
New Jersey
- Cooper Hospital Univ Med Ctr, MD Anderson at Cooper Voorhees - Voorhees Township
North Carolina
- Carolinas Medical Center/Levine Cancer Institute - Charlotte
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2017-01-20 |
| Est. Completion | 2028-01-31 |
| Phase | NA |
What NCT02945579 shows while recruiting
NCT02945579 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 482-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (75% lower).
The record links to 10 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.
NCT02945579 lists 8 locations in 8 states (Arizona, Florida, Hawaii).
Frequently Asked Questions
What is clinical trial NCT02945579 about?
NCT02945579 is a clinical study titled "Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy". This clinical trial studies eliminating surgery and/or radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual cancer, patients then receive standard breast radiotherapy with no surg...
What is the current status of trial NCT02945579?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2017-01-20. Estimated completion is 2028-01-31.
What conditions does trial NCT02945579 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, HER2/Neu Negative, Estrogen Receptor Negative, Progesterone Receptor Negative, HER2-Positive Breast Carcinoma.
What interventions are being tested in trial NCT02945579?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Undergo EBRT (RADIATION), Partial Breast Irradiation (RADIATION).
Who is sponsoring clinical trial NCT02945579?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02945579 being conducted?
This trial has 8 study locations across Arizona, Florida, Hawaii, Minnesota, New Jersey. 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 NCT02945579's enrollment target sits among peer trials
120 23rd of 45 higher than 22 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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