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PALbociclib CoLlaborative Adjuvant Study
NCT02513394 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,796 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance Foundation Trials, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02513394 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Alaska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02513394?
The interventions under investigation include: Palbociclib (DRUG), Standard Adjuvant Endocrine Therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02513394?
This trial is sponsored by Alliance Foundation Trials, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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