Back to resultsHigh Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Palbociclib
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
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)
- Genomic High-Risk in BCT score (≥ 4)
- Patients agreed to use effective contraception or not be of childbearing potential.
- Patient has adequate bone marrow and organ function
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Patient who is able to swallow and retain oral medication
- A FFPE tumor sample must be available for inclusion. The tumor sample must be taken from the excised primary tumor
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)
- Patients with lactose intolerance
- Patients with a hypersensitivity to IP and/or components of IP
- Pregnant women, women of childbearing potential or lactating women
- Patients who have serious underlying co-morbidities which could cause end-organ dysfunction
- A FFPE tumor sample is not available
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
palbociclib plus endocrine therapy treatement
Arm Description
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.
Outcomes
Primary Outcome Measures
3-year event-free survival
defined to be time from study entry to first event, where the first event is any type of recurrence
Secondary Outcome Measures
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.
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)
Adverse Events
Toxicity (Adverse Events) will be collected and evaluated according to the NCI CTCAE ver. 5.0
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.
Exploratory analysis of genomic biomarkers
Analysis of tumor/blood biomarker
Full Information
NCT ID
NCT04247633
First Posted
January 27, 2020
Last Updated
April 17, 2020
Sponsor
Samsung Medical Center
Collaborators
Korean Cancer Study Group
1. Study Identification
Unique Protocol Identification Number
NCT04247633
Brief Title
High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Korean Cancer Study Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
578 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
palbociclib plus endocrine therapy treatement
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Palbociclib
Other Intervention Name(s)
Ibrance
Intervention Description
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).
Primary Outcome Measure Information:
Title
3-year event-free survival
Description
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
Secondary Outcome Measure Information:
Title
overall survival
Description
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
Title
Prognostic and predictive effects of BCT
Description
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
Title
Adverse Events
Description
Toxicity (Adverse Events) will be collected and evaluated according to the NCI CTCAE ver. 5.0
Time Frame
up to 2 years
Title
Quality of Life (QoL)
Description
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
Title
Exploratory analysis of genomic biomarkers
Description
Analysis of tumor/blood biomarker
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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)
Genomic High-Risk in BCT score (≥ 4)
Patients agreed to use effective contraception or not be of childbearing potential.
Patient has adequate bone marrow and organ function
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Patient who is able to swallow and retain oral medication
A FFPE tumor sample must be available for inclusion. The tumor sample must be taken from the excised primary tumor
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)
Patients with lactose intolerance
Patients with a hypersensitivity to IP and/or components of IP
Pregnant women, women of childbearing potential or lactating women
Patients who have serious underlying co-morbidities which could cause end-organ dysfunction
A FFPE tumor sample is not available
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yeon Hee Park, M.D, Ph.D
Phone
2-3410-1780
Ext
82
Email
yhparkhmo@skku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
hyunjung shin
Phone
2-3410-6763
Ext
82
Email
hjds.shin@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeon Hee Park, MD, Ph.D
12. IPD Sharing Statement
Learn more about this trial
High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)
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