PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
NCT ID: NCT03423199
Last Updated: 2024-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2018-02-09
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
Palbociclib
Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Tamoxifen
Tamoxifen, 20mg, orally once daily (continuously)
Goserelin
For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks
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)
Placebo
Placebo, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Tamoxifen
Tamoxifen, 20mg, orally once daily (continuously)
Goserelin
For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks
Interventions
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Palbociclib
Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Placebo
Placebo, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Tamoxifen
Tamoxifen, 20mg, orally once daily (continuously)
Goserelin
For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Korean Cancer Study Group
OTHER
National Cancer Center, Japan
OTHER_GOV
Responsible Party
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Principal Investigators
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Kan Yonemori, MD, PhD
Role: STUDY_CHAIR
Department of Breast and Medical Oncology, National Cancer Center Hospital
Locations
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Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kindai University Hospital
Ōsaka-sayama, Osaka, Japan
Toranomon Hospital
Minato-Ku, Tokyo, Japan
Chiba Cancer Center
Chiba, , Japan
Kyusyu Cancer Center
Fukuoka, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
National Cancer Center Hospital
Tokyo, , Japan
National University Hospital
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
National Cancer Center
Gyeonggi-do, , South Korea
Ajou University Hospital
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Soeul, , South Korea
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Vetarans General Hospital
Taipei, , Taiwan
Sun Yat-Sen Cancer Center
Taipei, , Taiwan
Countries
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References
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Noguchi E, Yamanaka T, Mukai H, Yamamoto N, Chung CF, Lu YS, Chang DY, Sohn J, Kim GM, Lee KH, Lee SC, Iwasa T, Iwata H, Watanabe K, Jung KH, Tanabe Y, Kang SY, Yasojima H, Aogi K, Tokunaga E, Sim SH, Yap YS, Matsumoto K, Tseng LM, Umeyama Y, Sudo K, Kojima Y, Hata T, Kuchiba A, Shibata T, Nakamura K, Fujiwara Y, Tamura K, Yonemori K. A phase 3 study (PATHWAY) of palbociclib plus tamoxifen in patients with HR-positive/HER2-negative advanced breast cancer. NPJ Breast Cancer. 2024 Aug 22;10(1):76. doi: 10.1038/s41523-024-00684-w.
Other Identifiers
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WI217662
Identifier Type: OTHER
Identifier Source: secondary_id
NCCH1607
Identifier Type: -
Identifier Source: org_study_id
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