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Breast CancerPhase 2NCT04247633

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

A Phase 2 study testing Palbociclib in people with Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Palbociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
578 participants
Where
1 siteSouth Korea
Study dates
11 Feb 2020to Feb 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Yeon Hee Park, M.D, Ph.D contact

2-3410-1780 ext. 82

yhparkhmo@skku.edu

hyunjung shin contact

2-3410-6763 ext. 82

hjds.shin@samsung.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, 135-710

    Yeon Hee Park, MD, Ph.D

    Recruiting

Other trials in South Korea

About this study

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

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)

Read the 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
Being tested
Palbociclib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

    Also called Ibrance

    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).

Study groups in NCT04247633
Study groupRoleWhat they receive
palbociclib plus endocrine therapy treatementExperimental* 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.
Receives: Drug: Palbociclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 3 years

Secondary outcomes (5)

  1. overall survival

    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.

    Measured: up to 5 years

  2. Prognostic and predictive effects of BCT

    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.

    • BCT Score 0 - 4 (<4) :Low risk (G-low)
    • BCT score 4 - 10 (≥4) High risk (G-high)

    Measured: up to 5 years

  3. Adverse Events

    Toxicity (Adverse Events) will be collected and evaluated according to the NCI CTCAE ver. 5.0

    Measured: up to 2 years

  4. Quality of Life (QoL)

    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.

    Measured: up to 5 years

  5. Exploratory analysis of genomic biomarkers

    Analysis of tumor/blood biomarker

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study start11 Feb 2020
  3. Primary completionFeb 2023 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
578 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04247633
Sponsor's protocol ID
KCSG BR19-13
Status last verified
Apr 2020
First submitted
27 Jan 2020
Last updated
20 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib in people with Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yeon Hee Park, M.D, Ph.D (2-3410-1780 ext. 82, yhparkhmo@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year event-free survival (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04247633.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.

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