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Cancer drug access extended: pfizer study offers continued palbociclib to eligible patients

NCT ID NCT05226871

Disease control 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study provides continued access to the cancer drug palbociclib (IBRANCE) for up to 35 patients with breast or head and neck cancer who have already benefited from it in earlier Pfizer trials. Participants will keep taking their current treatment combination, which may include cetuximab, fulvestrant, or letrozole. The main goal is to monitor long-term safety by tracking serious side effects and any reasons for stopping treatment.

What this could mean

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

Active substance
Palbociclib (IBRANCE) combined with cetuximab, fulvestrant, or letrozole
What this could lead to
If successful, this study could show that long-term use of palbociclib is safe for patients with breast or head and neck cancer who have already benefited from it.
What could go wrong
This is a small, non-randomized study with only 35 participants, so results may not apply to everyone. It focuses on safety, not on proving the drug works better than other options.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Dec 2029

An estimate. End dates often move.

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.

Ages

18 years and older

Sex

Anyone

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: * Any participant who is receiving study treatment and deriving clinical benefit as determined by the investigator in a Pfizer-sponsored palbociclib Parent Study * Participants must agree to follow the reproductive criteria * Participants who are willing and able to comply with all scheduled visits, treatment plans, and other study procedures * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document and protocol Exclusion Criteria: * Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm head and neck cancer Head and Neck Neoplasms Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Breast cancer Head and neck cancer

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, 100021, China

  • Department of Medicine, Faculty of Medicine Siriraj Hospital

    Bangkok, 10700, Thailand

  • Faculty of Medicine, Ramathibodi Hospital, Mahidol University

    Ratchathewi, Bangkok, 10400, Thailand

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003, China

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460, Mexico

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council

    Dnipro, 49102, Ukraine

  • Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council

    Ivano-Frankivsk, 76000, Ukraine

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Cheng Kung University Hospital

    Tainan, 704302, Taiwan

  • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"

    Chernivtsi, Chernivetska Oblast, 58013, Ukraine

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110167, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • UCSF Helen Diller Comprehensive Cancer Center at Mission Bay

    San Francisco, California, 94158, United States

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