Single-arm Phase II Study of Palbociclib Plus Endocrine Therapy in Patients With High Risk ER-positive/HER2-negative T1-2N0-1 Early Breast Cancer Incorporating GenesWell™ BCT
Overview
- Phase
- Phase 2
- Intervention
- Palbociclib
- Conditions
- Breast Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 578
- Locations
- 1
- Primary Endpoint
- 3-year event-free survival
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
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)
Detailed Description
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).
Investigators
Yeon Hee Park
Clinical Professor, MD, PhD
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patient is an adult, ≥ 19 years old at the time of informed consent
- •Premenopausal and postmenopausal women or men with invasive breast cancer
- •De novo primary disease
- •Patient who performed surgery with curative aim
- •Patient who has negative surgical resection margins
- •Patient with histologically confirmed HER2-negative breast cancer
- •Patient with histologically and cytologically confirmed ER positive breast cancer by local laboratory testing
- •Pathological node assessment: pN0 or pN1
- •Tumor size ≥ 0.5 cm, and T1 or T2
- •Clinical High-Risk (Clinical high-risk patients as per the modified Adjuvant! Online guideline in the clinical trial MINADCT(Microarray in Node Negative Disease May Avoid Chemotherapy), refer to section 5.2.1)
Exclusion Criteria
- •Patient with recurred breast cancer
- •Patient with histologically confirmed ER negative
- •Patient with histologically confirmed HER2-positive
- •Pathological node assessment: pN2 or pN3
- •Patients has received neoadjuvant chemotherapy or endocrine therapy
- •Patient has received preoperative treatment with CDK 4/6 inhibitors.
- •Patient has received preoperative radiation therapy
- •Tumor size less than 0.5 cm
- •Patients with low clinical risk group (section 5.2.1)
- •Patients who low BCT risk group (BCT score\<4)
Arms & Interventions
palbociclib plus endocrine therapy treatement
* Patients with Clinical high risk/Genomic High risk (in BCT score)-high and ER positive/HER2 negative EBC after Curative Surgery * Palbociclib at a dose of 125mg, orally once daily on Day 1 to Day 21 followed by 7 days off in a 28-day cycle for a total duration of 2 years * Standard adjuvant endocrine therapy for a duration of at least 5 years from the start of the treatment.
Intervention: Palbociclib
Outcomes
Primary Outcomes
3-year event-free survival
Time Frame: up to 3 years
defined to be time from study entry to first event, where the first event is any type of recurrence
Secondary Outcomes
- Prognostic and predictive effects of BCT(up to 5 years)
- Exploratory analysis of genomic biomarkers(up to 5 years)
- overall survival(up to 5 years)
- Adverse Events(up to 2 years)
- Quality of Life (QoL)(up to 5 years)