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NCT02384239 · ClinicalTrials.gov registry record · Phase 2

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

A Phase 2 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 2
Development phase
70
Enrollment target

NCT02384239: Completed Phase 2 study, sponsored by University of California, San Francisco.

NCT02384239 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02384239, a Phase 2 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 2
Development phase
70 participants
Enrollment target

Study Summary

This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant or tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving palbociclib together with fulvestrant or tamoxifen citrate may work better in treating hormone receptor positive breast cancer.

Primary Outcome

Grade 3/4 neutropenia as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 in patients with prior exposure to 1-3 lines of chemotherapy for metastatic breast cancer

Interventions

  • DRUG Tamoxifen
  • DRUG Fulvestrant
  • DRUG Palbociclib

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2015-10-19
Est. Completion 2021-01-31
Phase Phase 2

What the finished NCT02384239 record still lists

NCT02384239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 3 interventions - of which Tamoxifen is the first listed.

NCT02384239 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02384239 about?

NCT02384239 is a clinical study titled "A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer". This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other plac...

What is the current status of trial NCT02384239?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2015-10-19. Estimated completion is 2021-01-31.

What interventions are being tested in trial NCT02384239?

The interventions under investigation include: Tamoxifen (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG).

Who is sponsoring clinical trial NCT02384239?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02384239's enrollment target sits among peer trials

70 937th of 2000 higher than 1,036 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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Source: ClinicalTrials.gov NCT02384239, the US trial registry maintained by the National Library of Medicine. NCT02384239 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.