- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03423199
PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY (PATHWAY)
March 20, 2024 updated by: National Cancer Center, Japan
Asian, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tamoxifen With or Without Palbociclib ± Goserelin in Women With Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer
This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
180
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chiba, Japan, 2608717
- Chiba Cancer Center
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Fukuoka, Japan, 8111395
- Kyusyu Cancer Center
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Osaka, Japan, 5400006
- National Hospital Organization Osaka National Hospital
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Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Aichi
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Nagoya, Aichi, Japan, 464-8681
- Aichi Cancer Center Hospital
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Chiba
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Kashiwa, Chiba, Japan, 2778577
- National Cancer Center Hospital East
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Ehime
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Matsuyama, Ehime, Japan, 7910280
- National Hospital Organization Shikoku Cancer Center
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Hokkaido
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Sapporo, Hokkaido, Japan, 0030804
- National Hospital Organization Hokkaido Cancer Center
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Hyogo
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Akashi, Hyogo, Japan, 6738558
- Hyogo Cancer Center
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Kanagawa
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Yokohama, Kanagawa, Japan, 2418515
- Kanagawa Cancer Center
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Osaka
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Ōsaka-sayama, Osaka, Japan, 5898511
- Kindai University Hospital
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Tokyo
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Minato-Ku, Tokyo, Japan, 1058470
- Toranomon Hospital
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Gyeonggi-do, Korea, Republic of, 10408
- National Cancer Center
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Gyeonggi-do, Korea, Republic of, 16499
- Ajou University Hospital
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Gyeonggi-do, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Soeul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
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Singapore, Singapore, 169610
- National Cancer Centre Singapore
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Singapore, Singapore, 119882
- National University Hospital
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Taipei, Taiwan, 10048
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Taipei Vetarans General Hospital
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Taipei, Taiwan, 11259
- Sun Yat-Sen Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women 18 years of age or older with histologically or cytologically proven locally advanced or metastatic breast cancer, not amenable to resection or radiation therapy with curative intent
- Documented diagnosis of HR+/HER2- breast cancer
- Any menopausal status
- Previously untreated with any endocrine therapy for their HR+/HER2- advanced breast cancer; or progressed while on or within 3 month from prior endocrine therapy other than tamoxifen for advanced breast cancer. If patients have adjuvant endocrine therapy, they must satisfy as follows: progressed 12 months or more since prior adjuvant endocrine therapy with tamoxifen; or progressed during or after adjuvant endocrine therapy with an aromatase inhibitor.
- Measurable disease or non-measurable disease as defined by RECIST ver.1.1
- Eastern Cooperative Oncology Group (ECOG) PS 0-1
- Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
Exclusion Criteria:
- Prior treatment with any CDK inhibitor, tamoxifen, everolimus, or agent that inhibits the PI3K-mTOR pathway
- Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
- Use of strong or moderate CYP3A4 and/or CYP2D6 inhibitors or inducers
- Major surgery or any anti-cancer therapy within 2 weeks of randomization
- Prior stem cell or bone marrow transplantation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Palbociclib + Tamoxifen ± Goserelin
Palbociclib 125 mg/day, orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously)
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Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Other Names:
Tamoxifen, 20mg, orally once daily (continuously)
For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks
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Active Comparator: Placebo + Tamoxifen ± Goserelin
Placebo orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously)
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Tamoxifen, 20mg, orally once daily (continuously)
For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks
Placebo, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: Baseline up to 3.5 years
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The time from the date of randomization to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first.
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Baseline up to 3.5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: From the randomization of the last patient up to 3 years
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The time from date of randomization to date of death due to any cause.
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From the randomization of the last patient up to 3 years
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Survival Probabilities at 1 year, 2 year, and 3 year
Time Frame: From the randomization of the last patient up to 3 years
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The probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate.
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From the randomization of the last patient up to 3 years
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Objective Response (OR)
Time Frame: Baseline up to 3.5 years
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Complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) ver.1.1 recorded from randomization until disease progression or death due to any cause.
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Baseline up to 3.5 years
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Duration of Response (DR)
Time Frame: Baseline up to 3.5 years
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The time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
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Baseline up to 3.5 years
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Clinical Benefit Response (CBR)
Time Frame: Baseline up to 3.5 years
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CR or PR or SD >=24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death of any cause.
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Baseline up to 3.5 years
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Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
Time Frame: Baseline up to 3.5 years
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The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer).
The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL.
Responses to all items are then converted to a 0 to 100 scale.
For functional and global QOL scales, higher scores represent a better level of functioning/QOL.
For symptom-oriented scales, a higher score represents more severe symptoms.
A 10-point or higher change in scores from baseline is considered clinically significant.
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Baseline up to 3.5 years
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Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
Time Frame: Baseline up to 3.5 years
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The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss).
QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'.
All scores are converted to a 0 to 100 scale.
For functional scales, higher scores represent a better level of functioning.
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Baseline up to 3.5 years
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Trough plasma concentrations of palbociclib
Time Frame: Cycle 1/Day 15 and Cycle 2/Day 15
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Ctrough for palbociclib
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Cycle 1/Day 15 and Cycle 2/Day 15
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Trough plasma concentrations of tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen
Time Frame: Cycle 2/Day 15 and Cycle 3/Day 15
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Ctrough for tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen
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Cycle 2/Day 15 and Cycle 3/Day 15
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Treatment-Emergent Adverse Events
Time Frame: From the first dose of the investigational product until 28 days after the last dose of study drugs
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From the first dose of the investigational product until 28 days after the last dose of study drugs
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kan Yonemori, MD, PhD, Department of Breast and Medical Oncology, National Cancer Center Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2018
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
January 9, 2018
First Submitted That Met QC Criteria
February 3, 2018
First Posted (Actual)
February 6, 2018
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protein Kinase Inhibitors
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Palbociclib
- Goserelin
- Tamoxifen
Other Study ID Numbers
- NCCH1607
- WI217662 (Other Identifier: Pfizer)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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