- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04247633
High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)
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 Overview
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).
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yeon Hee Park, M.D, Ph.D
- Phone Number: 82 2-3410-1780
- Email: yhparkhmo@skku.edu
Study Contact Backup
- Name: hyunjung shin
- Phone Number: 82 2-3410-6763
- Email: hjds.shin@samsung.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Recruiting
- Samsung Medical Center
-
Contact:
- Yeon Hee Park, MD, Ph.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: palbociclib plus endocrine therapy treatement
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: up to 5 years
|
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.
|
up to 5 years
|
Prognostic and predictive effects of BCT
Time Frame: up to 5 years
|
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.
|
up to 5 years
|
Adverse Events
Time Frame: up to 2 years
|
Toxicity (Adverse Events) will be collected and evaluated according to the NCI CTCAE ver.
5.0
|
up to 2 years
|
Quality of Life (QoL)
Time Frame: up to 5 years
|
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. |
up to 5 years
|
Exploratory analysis of genomic biomarkers
Time Frame: up to 5 years
|
Analysis of tumor/blood biomarker
|
up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCSG BR19-13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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