High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)

  • STATUS
    Recruiting
  • End date
    Feb 24, 2025
  • participants needed
    578
  • sponsor
    Samsung Medical Center
Updated on 24 January 2021
endocrine therapy
hormone therapy
HER2
primary tumor
erbb2
palbociclib
invasive breast cancer
immunostimulant
breast-conserving surgery
mammogram
her2/neu-negative breast cancer

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)

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).

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Palbociclib
Clinical Study IdentifierNCT04247633
SponsorSamsung Medical Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 19 yrs?
Gender: Male or Female
Do you have Breast Cancer?
Do you have any of these conditions: breast carcinoma or cancer, breast or Breast Cancer Diagnosis or Breast Cancer?
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
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