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

NCT ID: NCT04247633

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 578 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-11
• Study Completion Date: 2025-02-28

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Palbociclib

Intervention Type: 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).

Interventions

Palbociclib

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).

Intervention Type: DRUG

Other Intervention Names

Ibrance

Eligibility Criteria

Inclusion Criteria

1. Patient is an adult, ≥ 19 years old at the time of informed consent

2. Premenopausal and postmenopausal women or men with invasive breast cancer

3. De novo primary disease

4. Patient who performed surgery with curative aim

5. Patient who has negative surgical resection margins

6. Patient with histologically confirmed HER2-negative breast cancer

7. Patient with histologically and cytologically confirmed ER positive breast cancer by local laboratory testing

8. Pathological node assessment: pN0 or pN1

9. Tumor size ≥ 0.5 cm, and T1 or T2

10. 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)

11. Genomic High-Risk in BCT score (≥ 4)

12. Patients agreed to use effective contraception or not be of childbearing potential.

13. Patient has adequate bone marrow and organ function

14. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

15. Patient who is able to swallow and retain oral medication

16. A FFPE tumor sample must be available for inclusion. The tumor sample must be taken from the excised primary tumor

Exclusion Criteria

1. Patient with recurred breast cancer

2. Patient with histologically confirmed ER negative

3. Patient with histologically confirmed HER2-positive

4. Pathological node assessment: pN2 or pN3

5. Patients has received neoadjuvant chemotherapy or endocrine therapy

6. Patient has received preoperative treatment with CDK 4/6 inhibitors.

7. Patient has received preoperative radiation therapy

8. Tumor size less than 0.5 cm

9. Patients with low clinical risk group (section 5.2.1)

10. Patients who low BCT risk group (BCT score<4)

11. Patients with lactose intolerance

12. Patients with a hypersensitivity to IP and/or components of IP

13. Pregnant women, women of childbearing potential or lactating women

14. Patients who have serious underlying co-morbidities which could cause end-organ dysfunction

15. A FFPE tumor sample is not available

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korean Cancer Study Group

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yeon Hee Park

Clinical Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yeon Hee Park, M.D, Ph.D

Role: CONTACT

yhparkhmo@skku.edu

2-3410-1780 ext. 82

hyunjung shin

Role: CONTACT

hjds.shin@samsung.com

2-3410-6763 ext. 82

Facility Contacts

Yeon Hee Park, MD, Ph.D

Role: primary

Other Identifiers

KCSG BR19-13

Identifier Type: -

Identifier Source: org_study_id