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

NCT03423199

UnknownPhase 3

Sponsor: National Cancer Center, Japan

Conditions: Breast Neoplasms

Interventions: Palbociclib, Placebo, Tamoxifen, Goserelin

Countries: Japan, Singapore, South Korea, Taiwan

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).

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (23)
  • Nagoya, Aichi-ken, Japan
  • Kashiwa, Chiba, Japan
  • Matsuyama, Ehime, Japan
  • Sapporo, Hokkaido, Japan
  • Akashi, Hyōgo, Japan
  • Yokohama, Kanagawa, Japan
  • Ōsaka-sayama, Osaka, Japan
  • Minato-Ku, Tokyo, Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Osaka, Japan
  • Tokyo, Japan
  • Singapore, Singapore
  • Singapore, Singapore
  • Gyeonggi-do, South Korea
  • Gyeonggi-do, South Korea
  • Gyeonggi-do, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Soeul, South Korea
  • Taipei, Taiwan
  • Taipei, Taiwan
  • Taipei, Taiwan