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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: Active Phase 3 study of Breast Cancer, sponsored by Alliance Foundation Trials.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-b
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 |
What the registry record for NCT02513394 still lists
NCT02513394 is an interventional study that assigns participants to a tested intervention. Its 5,796 participants enrollment target places it among the larger protocols in the corpus, above the 2,799-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (107% higher).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT02513394's enrollment target sits among peer trials
5,796 24th of 1224 higher than 1,201 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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