Clinical trial NCT03423199: PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
Official title: Asian, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tamoxifen With or Without Palbociclib ± Goserelin in Women With Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: breast Cancer
palbociclib (PD-0332991)
tamoxifen
goserelin
any menopausal status
hormone receptor positive
HER2 negative
locally advanced
metastatic
Lead sponsor: National Cancer Center, Japan
Sponsor class: OTHER_GOV
Collaborators: name: Pfizer
name: Korean Cancer Study Group
First posted: 2018-02-06
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).


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

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Baseline up to 3.5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the randomization of the last patient up to 3 years
measure: Survival Probabilities at 1 year, 2 year, and 3 year
timeFrame: From the randomization of the last patient up to 3 years
measure: Objective Response (OR)
timeFrame: Baseline up to 3.5 years
measure: Duration of Response (DR)
timeFrame: Baseline up to 3.5 years
measure: Clinical Benefit Response (CBR)
timeFrame: Baseline up to 3.5 years
measure: Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
timeFrame: Baseline up to 3.5 years
measure: Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
timeFrame: Baseline up to 3.5 years
measure: Trough plasma concentrations of palbociclib
timeFrame: Cycle 1/Day 15 and Cycle 2/Day 15
measure: Trough plasma concentrations of tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen
timeFrame: Cycle 2/Day 15 and Cycle 3/Day 15
measure: Treatment-Emergent Adverse Events
timeFrame: From the first dose of the investigational product until 28 days after the last dose of study drugs
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Ōsaka-sayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Minato-Ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: Kyusyu Cancer Center
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Soeul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Vetarans General Hospital
city: Taipei
country: Taiwan
facility: Sun Yat-Sen Cancer Center
Study officials:
affiliation: Department of Breast and Medical Oncology, National Cancer Center Hospital
name: Kan Yonemori, MD, PhD
role: STUDY_CHAIR
References: