Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Palbociclib; Letrozole
Intervention description: 125 mg orally once daily with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle; 2.5 mg , orally once daily (continuously)
Intervention MeSH terms: Letrozole; Palbociclib
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Palbociclib; PD-0332991; pharmacokinetics; breast cancer patients; Chinese

Summary:

      As part of the global clinical development program for Palbociclib, studies are planned in
      cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients,
      as required by the Chinese Health Authorities, is therefore warranted. In addition, safety
      and efficacy will be also evaluated.

      The single and multiple 125 mg oral dose pharmacokinetics of Palbociclib will be
      characterized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ER(+), HER2(-), postmenopausal adult (ages 18-65 years, inclusive) Chinese women with
             proven diagnosis of adenocarcinoma of the breast with evidence locoregionally
             recurrent or metastatic disease not amenable to resection or radiation therapy with
             curative intent and for whom chemotherapy is not clinically indicated.

             a. Postmenopausal women: i. Prior bilateral surgical oophorectomy; or ii. Medically
             confirmed post-menopausal status defined as spontaneous cessation of regular menses
             for at least 12 consecutive months with no alternative pathological or physiological
             cause b. Documentation of histologically or cytologically confirmed diagnosis of: i.
             ER(+) breast cancer. c. Documentation of HER2(-) breast cancer. d. Previously
             untreated with any systemic anti cancer therapy for their locoregionally recurrent or
             metastatic ER+ disease.

          -  Measurable disease as defined per RECIST v.1.1 or bone-only disease. - Tumor lesions
             previously irradiated or subjected to other locoregional therapy will only be deemed
             measurable if disease progression at the treated site after completion of therapy is
             clearly documented.

        Exclusion Criteria:

          -  HER2-positive tumor as defined by documentation of erbB-2 gene amplification by FISH
             (as defined by a HER2/CEP17 ratio ≥2) or chromogenic in situ hybridization (CISH, as
             defined by the manufacturer's kit instruction) or documentation of HER2 overexpression
             by IHC (defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local
             laboratory results

          -  Patients with advanced, symptomatic, visceral spread, that are at risk of
             life-threatening complications in the short term (including patients with massive
             uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and
             over 50% liver involvement).