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Metastatic Breast CancerPhase 2NCT02592746

A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR+ MBC

A Phase 2 study testing Palbociclib, Exemestane and Leuprolide Acetate in people with Metastatic Breast Cancer, run by Samsung Medical Center at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Despite recent advances for the treatment of post-menopausal hormone receptor-positive BC, in the last decade there was no major improvement of hormonal therapy specifically for premenopausal metastatic breast cancer. Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Palbociclib, Exemestane and Leuprolide Acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
2 sitesSouth Korea
Study dates
Jun 2016to Jun 2021
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed metastatic breast cancer with measurable or evaluable disease: Patients who have progressed on distant metastatic sites after curative surgery or have stage IV breast cancer at diagnosis
  • Age > 19 years
  • ECOG performance status 0 - 2
  • Patient has HER2-negative breast cancer with IHC and/or FISH (or SISH, CISH) Patient has ER positive and/or PgR positive breast cancer by local laboratory testing
  • Patient is premenopausal. Premenopausal status is defined as either:
  • Patient had last menstrual period within the last 12 months B. If within three months of tamoxifen (tamoxifen) taking, C. In case of chemotherapy induced amenorrhea, the serum FSH ≤40IU/l
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  • A. Patient who have stage IV breast cancer at diagnosis, allow disease that progressed after 1st line chemotherapy. B. Patient who have stage IV breast cancer at diagnosis, allow disease that progressed after tamoxifen or goserelin. C. In case of recur/metastatic breast cancer, allow disease that progressed after 12 month of completion of neo/adjuvant chemotherapy .
  • Urine or serum HCG test must be negative.
  • Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
  • Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
  • Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)
  • Patients who were already established on bisphosphonate therapy may continue on bisphosphonates.
  • Patients agreed to use effective contraception or not of childbearing potential
  • Written informed consent
  • Consent to biomarker analysis.

Who cannot join

  • Postmenopausal women
  • Serious uncontrolled intercurrent infections
  • Serious intercurrent medical or psychiatric illness, including active cardiac disease
  • Pregnancy or breast feeding
  • Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or resected thyroid papillary carcinoma or other malignancy treated at least 5 years previously with no evidence of recurrence)
  • Patients has received previous endocrine treatments such as, aromatase inhibitor, exemestane in the metastatic setting
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  • Patients has received previous treatment with CDK 4/6 inhibitors, mTOR inhibitors, PIK3CA inhibitors or capecitabine
  • No symptomatic visceral metastasis
  • Known brain metastases unless treated and stable
  • Clinically significant uncontrolled conditions including, known active hepatitis B or hepatitis C.
  • QTc interval > 480 msec, family or personal history of long or short QT syndrome, or known history of QTc prolongation or Torsade de Pointes.
  • Known positive testing for human immunodeficiency virus or acquired immune deficiency syndrome.
  • Unable to swallow and retain oral medication.
  • Treatment radiotherapy within 4 weeks of the study
  • Use of any investigational drug within 4 weeks of the study
  • Treatment with chemotherapy within 3 weeks or hormone therapy within 2 weeks of the study

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Samsung Medical Center

    Seoul, 135-710

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: A Phase II Randomized Study of Palbociclib in Combination With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer

Despite recent advances for the treatment of post-menopausal hormone receptor-positive BC, in the last decade there was no major improvement of hormonal therapy specifically for premenopausal metastatic breast cancer. The median age of breast cancer is much younger, and the proportion of young breast cancer (YBC) patients (less than 40) including premenopausal women is much higher, in Asia, including Korea.

Capecitabine, the comparator in this trial, is an orally-administered fluoropyrimidine derivative and has shown high efficacy and low toxicity in metastatic breast cancer patients. Palbociclib is a CDK4/6 inhibitors, in combination with endocrine therapy showed marked advance in hormone receptor-positive MBC in the post-menopausal setting. After a median follow-up of 16.5 months, preliminary results from Part 1 of this Phase 2 trial suggest that the combination of PD-0332991 with letrozole is superior to letrozole alone, and improved objective response and disease control rates (52% vs 32% and 76% vs 47%, respectively) in patients treated with the combination. These remarkable results may contribute to have much benefit with endocrine therapy for premenopausal women. Most importantly, recent PALOMA-3 trial revealed superior results of adding palbociclib to fulvestrant (median PFS 9.2 vs 3.8 months, P<0.001).

Based on these rational backgrounds, the purpose of this phase II study is to assess the safety and the clinical anti-tumor activity of exemestane plus goserelin acetate in combination with palbociclib vs capecitabine in premenopausal hormone receptor-positive advanced breast cancer patients

Being tested
Palbociclib, Exemestane, Leuprolide Acetate, Capecitabine
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 PD-0332991

    Palbociclib 125mg, orally once daily on D1 to D21 followed by 7days off

  • ExemestaneDrug

    Also called FCE-24304

    Exemestane 25mg, orally once daily

  • Leuprolide AcetateDrug

    Also called GnRH agonist

    Leuprolide Acetate 3.75mg SC q 4weeks

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine 1,250mg/m2 bid orally form day1 to day 14 q 3weeks

Study groups in NCT02592746
Study groupRoleWhat they receive
Palbociclib + Exemestane + GnRH agonistExperimentalNot described
Receives: Drug: Palbociclib; Drug: Exemestane; Drug: Leuprolide Acetate
CapecitabineActive comparatorNot described
Receives: Drug: Capecitabine

What is being measured

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

  1. Progression free survival (PFS) in patients with metastatic breast cancer who received palbociclib plus exemestane with goserelin versus capecitabine

    Measured: 1year

Timeline

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

  1. First posted30 Oct 2015 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2021 (estimated)
  4. Study completionJun 2021 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
182 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02592746
Sponsor's protocol ID
2015-08-042
Status last verified
Apr 2019
First submitted
29 Oct 2015
Last updated
8 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Ahn HK, Kim JY, Lee KH, Kim GM, Kang SY, Lee KS, Kim JH, Lee KE, Lee MH, Kim HJ, Kim HJ, Koh SJ, Park IH, Sohn J, Kim SB, Ahn JS, Kim S, Cho H, Jung KH, Im SA, Park YH; Korean Cancer Study Group (KCSG) Breast Cancer Committee. Palbociclib plus endocrine therapy versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (Young-PEARL): overall survival analysis of a randomised, open-label, phase 2 study. Lancet Oncol. 2025 Mar;26(3):343-354. doi: 10.1016/S1470-2045(25)00006-3. Epub 2025 Feb 17.

    PubMed 39978378

  • Park YH, Kim TY, Kim GM, Kang SY, Park IH, Kim JH, Lee KE, Ahn HK, Lee MH, Kim HJ, Kim HJ, Lee JI, Koh SJ, Kim JY, Lee KH, Sohn J, Kim SB, Ahn JS, Im YH, Jung KH, Im SA; Korean Cancer Study Group (KCSG). Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2019 Dec;20(12):1750-1759. doi: 10.1016/S1470-2045(19)30565-0. Epub 2019 Oct 24.

    PubMed 31668850

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib, Exemestane and Leuprolide Acetate in people with Metastatic Breast Cancer, run by Samsung Medical Center at 2 sites 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 15 inclusion and 16 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 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) in patients with metastatic breast cancer who received palbociclib plus exemestane with goserelin versus capecitabine (time frame: 1year). 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 NCT02592746, which also lists 2 linked publications.

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 8 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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