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New drug combo shows promise for advanced breast cancer in asian women

NCT ID NCT02297438

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding palbociclib (a targeted cancer drug) to standard hormone therapy (letrozole) helps Asian postmenopausal women with a certain type of advanced breast cancer (ER+/HER2-). The trial involved 340 women who had not received prior treatment for their advanced disease. The main goal was to see if the combination delayed cancer growth compared to letrozole alone.

What this could mean

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

Active substance
Palbociclib (a targeted cancer drug) combined with letrozole (a hormone therapy)
What this could lead to
If successful, this combination could delay cancer progression in Asian women with advanced breast cancer, offering a new treatment option.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to other populations. Side effects of palbociclib can include low blood cell counts and fatigue.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

340 people

The number who actually took part.

Started

Mar 2015

Finished

Feb 2025

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 to 70 years

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: * Adult Asian women with locoregionally recurrent or metastatic disease not amenable to curative therapy * Confirmed diagnosis of ER positive breast cancer * No prior systemic anti-cancer therapy for advanced ER+ disease * Postmenopausal women * Measurable disease as per Response Evaluation Criterion in Solid Tumors \[RECIST\] or bone-only disease * Eastern Cooperative Oncology Group \[ECOG\] 0-1 * Adequate organ and marrow function * Patient must agree to provide tumor tissue Exclusion Criteria: * Confirmed diagnosis of HER2 positive disease * Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term * Known uncontrolled or symptomatic CNS metastases * Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment * Prior treatment with any CDK 4/6 inhibitor

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer Neoplasm Metastasis

As listed by the trial registrant

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

Breast neoplasms

Contacts and locations

Locations

  • 307 Hospital of PLA

    Beijing, 100071, China

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510120, China

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021, China

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chinese PLA General Hospital/Oncology

    Beijing, 100853, China

  • Chula Clinical Research Center (Chula CRC)

    Patumwan, Bangkok, 10330, Thailand

  • Department of Clinical Oncology

    Hong Kong, Hong Kong

  • Department of Medicine, Faculty of Medicine, Naresuan University

    Muang, Changwat Phitsanulok, 65000, Thailand

  • Division of Medical Oncology, Department of Medicine,

    Bangkok, 10700, Thailand

  • Division of Therapeutic Radiology and Oncology, Department of Radiology

    Muang, Chiang Mai, 50200, Thailand

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011, China

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Fujian Medical University Union Hospital/Medical Oncology Department

    Fuzhou, Fujian, 350001, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510120, China

  • Harbin Medical University Cancer Hospital/Oncology Department

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Hunan Provincial Tumor Hospital/Breast Internal Medicine Department

    Changsha, Hunan, 410013, China

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Jilin Provincial Cancer Hospital

    Changchun, Jilin, 130103, China

  • King Chulalongkorn Memorial Hospital

    Pathumwan, Bangkok, 10330, Thailand

  • Koo Foundation, Sun Yat-Sen Cancer Center

    Taipei, 11259, Taiwan

  • Liaoning Province Cancer Hospital

    Shenyang, Liaoning, 110042, China

  • Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • National Cheng Kung University Hospital / Internal Medicine

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Oncology Department, the Second Affiliated Hospital of Third Military Medical University, PLA

    Chongqing, 400037, China

  • Oncology Unit, Department of Internal Medicine, Phramongkutklao Hospital

    Bangkok, 10400, Thailand

  • Parkway Cancer Centre

    Singapore, 258500, Singapore

  • Peking University Third Hospital/Department of Oncology

    Beijing, 100191, China

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Raffles Cancer Centre

    Singapore, 188770, Singapore

  • Ramathibodi Hospital, Mahidol University

    Bangkok, Ratchathevi, 10400, Thailand

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology

    Hangzhou, Zhejiang, 310016, China

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Taipei Medical University Hospital/ Department of Surgery

    Taipei, 110, Taiwan

  • Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University )

    Taipei, 116, Taiwan

  • Taipei Veterans General Hospital/Surgery Department

    Taipei, 11217, Taiwan

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • Tan Tock Seng Hospital

    Singapore, 308442, Singapore

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of China Medical University/Oncology Department

    Shenyang, Liaoning, 110001, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • The Tumor Hospital of Yunnan Province

    Kunming, Yunnan, 650118, China

  • Tianjin Cancer Hospital/Breast cancer department

    Tianjin, Tianjin Municipality, 300060, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhongshan Ophthalmic Center,Sun Yat-Sen University

    Guangzhou, Guangdong, 510060, China

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