This is a phase II, multi-center, single-arm, open-label trial to evaluate efficacy of palbociclib with endocrine therapy as adjuvant treatment in women with C-high/G-high risk ER-positive/HER2-negative T1-2N0-1 EBC(Early Breast Cancer)
The investigators hypothesized that the GenesWell™ BCT may help inform decision about whether or not to have adjuvant chemotherapy to patients with high-risk pN0-N1, ER+/HER2- breast cancer in Korea. While adjuvant therapy for ER-positive EBC is effective in reducing risk of recurrence and improving survival, recurrences are still common, especially in patients with unfavorable factors in terms of clinical, pathological and/or molecular perspectives. Since the addition of CDK4/6 inhibitor, palbociclib, to endocrine therapy (ET) has proven clinical efficacy with tolerable toxicity profile in ER-positive, HER2-negative advanced BC, its use in the adjuvant setting may decrease risk of recurrences in patients with ER-positive, HER2-negative EBC after surgical resection of the primary tumor by enhancing primary endocrine responsiveness and preventing, or delaying the development of acquired resistance for endocrine therapy. The purpose of this study is to evaluate the effect of addition of palbociclib to standard adjuvant ET on event-free survival (EFS) in patients with ER-positive, HER2-negative EBC but unfavorable clinicopathological (clinical high risk, C-high) and molecular features (genomic high risk, G-high).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
578
Palbociclib at a dose of 125 mg will be administered orally once a day for 21 days, followed by 7 days off treatment of every 28 day cycle. Investigational medicinal product (IMP) will be administered with standard adjuvant endocrine therapy (Non-investigational treatment).
Samsung Medical Center
Seoul, South Korea
RECRUITING3-year event-free survival
defined to be time from study entry to first event, where the first event is any type of recurrence
Time frame: up to 3 years
overall survival
defined to be time from study entry to the death from any cause. Patients who lost to follow-up or have withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first.
Time frame: up to 5 years
Prognostic and predictive effects of BCT
BCT score (of GenesWell™ BCT) as a biomarker to determine the efficacy of palbociclib in combination with endocrine therapy in adjuvant setting in T1-2N0-1 high risk ER+ EBC. Performance analysis of BCT score (of GenesWell™ BCT) about predicting the effectiveness of IP. * BCT Score 0 - 4 (\<4) :Low risk (G-low) * BCT score 4 - 10 (≥4) High risk (G-high)
Time frame: up to 5 years
Adverse Events
Toxicity (Adverse Events) will be collected and evaluated according to the NCI CTCAE ver. 5.0
Time frame: up to 2 years
Quality of Life (QoL)
The QoL will be evaluated using European Organization for Research and Treatment of Cancer QoL Questionnaire (EORTC QLQ-C30, and B-23) -These two tools for measuring quality of life were evaluated on a scale of 100 in accordance with the formula. The higher the score, the better the quality of life, and the higher the score, the more appealing the symptom scale.
Time frame: up to 5 years
Exploratory analysis of genomic biomarkers
Analysis of tumor/blood biomarker
Time frame: up to 5 years
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