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NCT02712723 · ClinicalTrials.gov registry record · Phase 2
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Qamar Khan.
- Active
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
- 13
- Study locations
NCT02712723: Active Phase 2 study of Breast Cancer, sponsored by Qamar Khan.
NCT02712723 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by Qamar Khan. The registered enrollment target is 121 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02712723, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by Qamar Khan.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.
Primary Outcome
The Preoperative Endocrine Prognostic Index (PEPI) score 0 is defined as: pT stage 0, 1, or 2 at surgery after 24 weeks of neoadjuvant therapy; negative axillary lymph nodes at surgey; Ki67 of ≤ 2.7 % at surgery; and tumor is ER+ at surgery. A PEPI score of 0 predicts a good outcome compare to PEPI score \>0.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Letrozole
- DRUG Ribociclib
Study Locations (13)
Kansas
- University of Kansas Cancer Center - West - Kansas City
- University of Kansas Cancer Center - Overland Park - Overland Park
- University of Kansas Cancer Center - Westwood - Westwood
Missouri
- University of Kansas Cancer Center - South - Kansas City
- University of Kansas Cancer Center - North - Kansas City
- University of Kansas Cancer Center - Lee's Summit - Lee's Summit
California
- City of Hope National Medical Center - Duarte
- Cancer Research Collaboration - Santa Ana
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Columbia University Medical Center - New York
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2016-02 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT02712723 still lists
NCT02712723 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02712723 lists 13 locations in 8 states (Kansas, Missouri, California).
Frequently Asked Questions
What is clinical trial NCT02712723 about?
NCT02712723 is a clinical study titled "Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer". The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with letrozole alone therefore...
What is the current status of trial NCT02712723?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2016-02. Estimated completion is 2026-12.
What conditions does trial NCT02712723 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02712723?
The interventions under investigation include: Placebo (DRUG), Letrozole (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT02712723?
This trial is sponsored by Qamar Khan, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02712723 being conducted?
This trial has 13 study locations across Arkansas, California, Florida, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02712723's enrollment target sits among peer trials
121 506th of 1224 higher than 716 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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