Clinical Trials /

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

NCT04247633

Description:

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)

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: KCSG BR19-13
  • NCT ID: NCT04247633

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
PalbociclibIbrancepalbociclib plus endocrine therapy treatement

Purpose

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

      We 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).
    

Trial Arms

NameTypeDescriptionInterventions
palbociclib plus endocrine therapy treatementExperimentalPatients 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.
  • Palbociclib

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:3-year event-free survival
Time Frame:up to 3 years
Safety Issue:
Description:defined to be time from study entry to first event, where the first event is any type of recurrence

Secondary Outcome Measures

Measure:overall survival
Time Frame:up to 5 years
Safety Issue:
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.
Measure:Prognostic and predictive effects of BCT
Time Frame:up to 5 years
Safety Issue:
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
Measure:Adverse Events
Time Frame:up to 2 years
Safety Issue:
Description:Toxicity (Adverse Events) will be collected and evaluated according to the NCI CTCAE ver. 5.0
Measure:Quality of Life (QoL)
Time Frame:up to 5 years
Safety Issue:
Description:The QoL will be evaluated using European Organization for Research and Treatment of Cancer QoL Questionnaire (EORTC QLQ-C30, and B-23)
Measure:Exploratory analysis of genomic biomarkers
Time Frame:up to 5 years
Safety Issue:
Description:Analysis of tumor/blood biomarker

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Samsung Medical Center

Last Updated

January 27, 2020