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

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ClinicalTrials.gov Identifier: NCT02592746
Recruitment Status : Unknown
Verified April 2019 by Yeon Hee Park, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : April 8, 2019
Information provided by (Responsible Party):
Yeon Hee Park, Samsung Medical Center

Brief 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. 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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Palbociclib Drug: Exemestane Drug: Leuprolide Acetate Drug: Capecitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Palbociclib + Exemestane + GnRH agonist Drug: Palbociclib
Palbociclib 125mg, orally once daily on D1 to D21 followed by 7days off
Other Name: PD-0332991

Drug: Exemestane
Exemestane 25mg, orally once daily
Other Name: FCE-24304

Drug: Leuprolide Acetate
Leuprolide Acetate 3.75mg SC q 4weeks
Other Name: GnRH agonist

Active Comparator: Capecitabine Drug: Capecitabine
Capecitabine 1,250mg/m2 bid orally form day1 to day 14 q 3weeks
Other Name: Xeloda

Primary Outcome Measures :
  1. Progression free survival (PFS) in patients with metastatic breast cancer who received palbociclib plus exemestane with goserelin versus capecitabine [ Time Frame: 1year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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
  2. Age > 19 years
  3. ECOG performance status 0 - 2
  4. 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
  5. Patient is premenopausal. Premenopausal status is defined as either:

    A. 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

  6. 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 .
  7. Urine or serum HCG test must be negative.
  8. Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
  9. Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
  10. Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)
  11. Patients who were already established on bisphosphonate therapy may continue on bisphosphonates.
  12. Patients agreed to use effective contraception or not of childbearing potential
  13. Written informed consent
  14. Consent to biomarker analysis.

Exclusion Criteria:

  1. Postmenopausal women
  2. Serious uncontrolled intercurrent infections
  3. Serious intercurrent medical or psychiatric illness, including active cardiac disease
  4. Pregnancy or breast feeding
  5. 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)
  6. Patients has received previous endocrine treatments such as, aromatase inhibitor, exemestane in the metastatic setting
  7. Patients has received previous treatment with CDK 4/6 inhibitors, mTOR inhibitors, PIK3CA inhibitors or capecitabine
  8. No symptomatic visceral metastasis
  9. Known brain metastases unless treated and stable
  10. Clinically significant uncontrolled conditions including, known active hepatitis B or hepatitis C.
  11. QTc interval > 480 msec, family or personal history of long or short QT syndrome, or known history of QTc prolongation or Torsade de Pointes.
  12. Known positive testing for human immunodeficiency virus or acquired immune deficiency syndrome.
  13. Unable to swallow and retain oral medication.
  14. Treatment radiotherapy within 4 weeks of the study
  15. Use of any investigational drug within 4 weeks of the study
  16. Treatment with chemotherapy within 3 weeks or hormone therapy within 2 weeks of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592746

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yeon Hee Park, MD, Ph.D, Division of Hematology-Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02592746    
Other Study ID Numbers: 2015-08-042
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists