Status:
ACTIVE_NOT_RECRUITING
PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
Lead Sponsor:
National Cancer Center, Japan
Collaborating Sponsors:
Pfizer
Korean Cancer Study Group
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03423199
Start Date
February 9 2018
End Date
September 1 2025
Last Update
March 22 2024
Active Locations (23)
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1
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan, 464-8681
2
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 2778577
3
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 7910280
4
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 0030804