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

NCT04247633 | Unknown Phase 2

• 1 other identifier: KCSG BR19-13
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 1

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)

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year event-free survival

  defined to be time from study entry to first event, where the first event is any type of recurrence

  up to 3 years

Secondary Outcomes (5)

• overall survival

  up to 5 years

• Prognostic and predictive effects of BCT

  up to 5 years

• Adverse Events

  up to 2 years

• Quality of Life (QoL)

  up to 5 years

• Exploratory analysis of genomic biomarkers

  up to 5 years

Study Arms (1)

palbociclib plus endocrine therapy treatement

EXPERIMENTAL

* 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.

Drug: Palbociclib

Interventions

Palbociclib DRUG

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).

Also known as: Ibrance

palbociclib plus endocrine therapy treatement

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Korean Cancer Study Group: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yeon Hee Park, M.D, Ph.D

CONTACT

2-3410-1780; yhparkhmo@skku.edu

hyunjung shin

CONTACT

2-3410-6763; hjds.shin@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, MD, PhD

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: February 11, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2025
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

KR (1)