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Japanese breast cancer survival data reviewed for palbociclib combo

NCT ID NCT04735367

Knowledge-focused Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study in Japan reviewed medical records of 42 patients with HR+/HER2- advanced breast cancer who had been treated with palbociclib plus letrozole. The goal was to see how long patients lived after starting this treatment. It was a follow-up to an earlier phase 2 study and did not involve any new treatments or procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
palbociclib plus letrozole
What this could lead to
If successful, this study could confirm the real-world survival benefit of this drug combination for Japanese patients with advanced breast cancer.
What could go wrong
This is a small, retrospective observational study with only 42 patients, so results may not apply to broader populations. It does not test a new treatment, only reviews past data.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

42 people

The number who actually took part.

Started

Feb 2021

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who participated, treated with palbociclib plus letrozole, and under follow-up for survival in J-Ph2

Ages

20 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participated, treated with palbociclib plus letrozole in J-Ph2, and was under follow-up for survival at the study completion of J-Ph2. 2. For patients who are still alive and have routine visits to the study site, evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. For patients who are still alive and had been transferred to another hospital, evidence that the patient has been informed of all pertinent aspects of the study and oral or written informed consent is obtained. For patients who had already passed away, the conduct of this study will be disclosed, and the patients' legally acceptable representatives will be guaranteed an opportunity to refuse data collection for the patients in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects Exclusion Criteria: 1\. There are no exclusion criteria for this study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Aichi Cancer Center

    Nagoya, 464-8681, Japan

  • Chiba cancer center

    Chiba, Chiba, 260-8717, Japan

  • Hakuaikai Medical Corporation Sagara Hospital

    Kagoshima, 892-0833, Japan

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima, 730-8518, Japan

  • Kumamoto Shinto General Hospital

    Kumamoto, 862-8655, Japan

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556, Japan

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research

    Osaka, 540-0006, Japan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • Saitama Cancer Center

    Kita-adachi-gun, Saitama, 362-0806, Japan

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