For Healthcare Professionals

PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY


About the study

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).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. 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
  2. Documented diagnosis of HR+/HER2- breast cancer
  3. Any menopausal status
  4. 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.
  5. Measurable disease or non-measurable disease as defined by RECIST ver.1.1
  6. Eastern Cooperative Oncology Group (ECOG) PS 0-1
  7. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures


Exclusion Criteria:

  1. Prior treatment with any CDK inhibitor, tamoxifen, everolimus, or agent that inhibits the PI3K-mTOR pathway
  2. Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
  3. Use of strong or moderate CYP3A4 and/or CYP2D6 inhibitors or inducers
  4. Major surgery or any anti-cancer therapy within 2 weeks of randomization
  5. Prior stem cell or bone marrow transplantation

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Breast Neoplasms

Age (in years)



Phase 3

Participants needed


Est. Completion Date

Apr 30, 2025

Treatment type



National Cancer Center, Japan identifier


Study number


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