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NCT02513394 · ClinicalTrials.gov registry record · Phase 3
PALbociclib CoLlaborative Adjuvant Study
A Phase 3 study of Breast Cancer, sponsored by Alliance Foundation Trials.
- Active
- Registry status
- Phase 3
- Development phase
- 5,796
- Enrollment target
- 20
- Study locations
NCT02513394 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Alliance Foundation Trials. The registered enrollment target is 5,796 participants, above the 2,799-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (107% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT02513394, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Alliance Foundation Trials.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 5,796 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.
Conditions Studied
Interventions
- DRUG Palbociclib
- DRUG Standard Adjuvant Endocrine Therapy
Study Locations (20)
California
- Kaiser Permanente Anaheim Medical Center - Anaheim
- Kaiser Permanente Baldwin Park Medical Center - Baldwin Park
- Kaiser Permanente Bellflower Medical Center - Bellflower
- Kaiser Permanente Fontana Medical Center - Fontana
- Marin Cancer Care - Greenbrae
- Marin Cancer Center - Greenbrae
- Kaiser Permanente Harbor City Medical Center - Harbor City
- Kaiser Permanente Irvine Medical Center - Irvine
- UCSD Moores Cancer Center - La Jolla
- Long Beach Memorial Medical Center - Todd Cancer Institute - Long Beach
- Kaiser Permanente Sunset Medical Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Kaiser Permanente Oakland Medical Center - Oakland
- Palo Alto Medical Foundation Health Care - Palo Alto
- Kaiser Permanente Panorama City Medical Center - Panorama City
Alabama
- University of South Alabama Mitchell Cancer Institute - Mobile
- Southern Cancer Center PC - Providence - Mobile
Alaska
- Katmai Oncology Group - Anchorage
- Providence Alaska Cancer Center - Anchorage
Arizona
- Mayo Clinic in Arizona - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,796 participants |
| Start Date | 2015-08 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02513394
The ClinicalTrials.gov registry entry for NCT02513394 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 5,796 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,799-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (107% higher). The listed sponsor is Alliance Foundation Trials, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Palbociclib is the first listed.
NCT02513394 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Alaska.
Frequently Asked Questions
What is clinical trial NCT02513394 about?
NCT02513394 is a clinical study titled "PALbociclib CoLlaborative Adjuvant Study". This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whethe...
What is the current status of trial NCT02513394?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 5,796 participants. The study started on 2015-08. Estimated completion is 2028-12.
What conditions does trial NCT02513394 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02513394?
The interventions under investigation include: Palbociclib (DRUG), Standard Adjuvant Endocrine Therapy (DRUG).
Who is sponsoring clinical trial NCT02513394?
This trial is sponsored by Alliance Foundation Trials, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02513394 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.