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NCT02040857 · ClinicalTrials.gov registry record · Phase 2
Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
NCT02040857: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT02040857 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 162 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02040857, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 162 participants
- Enrollment target
Study Summary
This research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer. * Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a pathway, or a sequence of steps which is known to regulate cell growth. Laboratory testing has suggested palbociclib may stop the growth of hormone receptor positive breast cancer. * Endocrine therapy prevents breast cancer cell growth by blocking estrogen stimulation. During this study endocrine therapy will either be tamoxifen or an aromatase inhibitor. It is standard of care for premenopausal women to take tamoxifen and for postmenopausal women to take either an aromatase inhibitor or tamoxifen after a diagnosis of hormone receptor positive breast cancer.
Primary Outcome
The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in uncensored participants. Participants who discontinued palbociclib early for reasons that were not treatment-related were censored.
Interventions
- DRUG Palbociclib
- DRUG Aromatase Inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2014-01 |
| Est. Completion | 2024-12-27 |
| Phase | Phase 2 |
What the finished NCT02040857 record still lists
NCT02040857 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 2 interventions - of which Palbociclib is the first listed.
NCT02040857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02040857 about?
NCT02040857 is a clinical study titled "Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer". This research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer. * Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks activity of two closely related enzymes (protein...
What is the current status of trial NCT02040857?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2014-01. Estimated completion is 2024-12-27.
What interventions are being tested in trial NCT02040857?
The interventions under investigation include: Palbociclib (DRUG), Aromatase Inhibitor (DRUG).
Who is sponsoring clinical trial NCT02040857?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02040857's enrollment target sits among peer trials
162 418th of 2000 higher than 1,579 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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