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PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03900637
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Wonshik Han, Seoul National University Hospital

Study Description
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Brief Summary:
In ER+ and HER2- breast cancer(BC) patients for whom BCS is not feasible, we investigate the rate of BCS can be increased while decreasing unnecessary chemotherapy thru selective neoadjuvant chemotherapy or neoadjuvant endocrine therapy using tools of nodal status, Ki-67, and multigene assay(Mammaprint)

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Leuprorelin acetate Drug: Letrozole Genetic: MammaPrint Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-institutional Study to Increase Breast Conserving Surgery (BCS) Rate With Personalized Neoadjuvant Strategy in ER Positive and HER2 Negative Breast Cancer Patients for Whom BCS is Not Feasible
Actual Study Start Date : November 8, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I

  1. MammaPrint high risk :

    • Neoadjuvant chemotherapy : Adriamycin/Cyclophosphamide #4 followed by Docetaxel #4

  2. MammaPrint low risk :

    • Premenopausal women : Letrozole 2.5mg PO QD + leuprorelin acetate 3.6mg SQ every 4weeks during 16 weeks (if needed, maximum for 24 weeks)
    • Postmenopausal women : Letrozole 2.5mg PO QD during 16 weeks (if needed, maximum for 24 weeks)
 Drug: Leuprorelin acetate
In premenopausal women, 3.75mg of leuprorelin acetate is subcutaneously administered once every 4 weeks for 16 weeks. (if needed, maximum for 24 weeks)
Other Name: Leuplin

Drug: Letrozole
2.5 mg tablet is orally administered once a day, without regard to meals, for 16 weeks (if needed, maximum for 24 weeks)
Other Names:
  • Lenara
  • Bretra

Genetic: MammaPrint
In this study, patients with MammaPrint test is performed, neoadjuvant chemotherapy is conducted to genomic High Risk patients, and neoadjuvant endocrine therapy is conducted to Low Risk patients.


Outcome Measures
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Primary Outcome Measures :
  1. Conversion Rate [ Time Frame: 4 months(maximum 6 months) ]
    Evaluate the conversion rate from BCS-ineligible to BCS-eligible patients


Secondary Outcome Measures :
  1. Actual Conversion Rate [ Time Frame: 4 months(maximum 6 months) ]
    Evaluate the actual performance rate of BCS

  2. pCR [ Time Frame: 4 months(maximum 6 months) ]
    Evaluate pathological complete response

  3. cCR [ Time Frame: 4 months(maximum 6 months) ]
    Evaluate clinical response rate

  4. Tumor Size Reduction Rate [ Time Frame: 4 months(maximum 6 months) ]
    Evaluate the accomplished rate of targeted tumor size reduction which enable to make BCS possible at presentation


Other Outcome Measures:
  1. DFS [ Time Frame: 5 years ]
    Evaluate disease free survivals

  2. IBTR [ Time Frame: 5 years ]
    Evaluate ipsilateral breast tumor recurrence

  3. Blueprint subtype [ Time Frame: 4 months(maximum 6 months) ]
    Evaluate response rate by Blueprint subtype


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

Inclusion Criteria:

  1. Histopathologically and immunohistochemically confirmed ER+ and HER2- BC patients
  2. Stage I-IIIA BC patients with detectable tumor sizes
  3. BC patients for whom BCS is not feasible due to tumor sizes or locations (two surgeons at each institution evaluate the infeasibility of BCS)
  4. Patients without distant metastasis which were identified pathologically or radiologically

  5. Female patients ≥ 19 years

    • Diagnosis of menopause is defined as no menstruation for 1-year or both ovaries removed surgically
  6. ECOG 0-2

  7. Patients with adequate bone marrow function

    • Hemoglobin 10 g/dL, ANC 1,500/mm3, Plt 100,000/mm3

  8. Patients with adequate kidney function

    • serum Cr ≤ 1.5 mg/dL

  9. Patients with adequate liver function

    • Bilirubin: ≤ 1.5 times of upper normal limit
    • AST/ALT: ≤ 1.5 times of upper normal limit
    • Alkaline phosphatase: ≤ 1.5 times of upper normal limit
  10. Patients who decided to voluntarily participate in this trial with written informed consent

Exclusion Criteria:

  1. History of treatment for ipsilateral BC or breast carcinoma in situ
  2. Confirmed distant metastasis of BC
  3. History of cancer other than BC
  4. Pregnant (positive pregnancy test within a week of enrollment) or breast-feeding patients
  5. Uncontrolled severe infection
  6. Psychiatric illness or epilepsy
  7. Male BC patients
  8. Inability to understand and willingness to sign a written informed consent
  9. Mammographic extensive microcalcification
  10. Multicentral, Bilateral BC
  11. History of chemotherapy or endocrine therapy on contralateral BC for the past 2 years
  12. ER-
  13. HER2+
  14. Undetectable and unmeasurable primary tumor size
Contacts and Locations
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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): NCT03900637


Contacts
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Contact: Wonshik Han +82-2-2072-1958 hanw@snu.ac.kr
Contact: Jigwang Jung +82-2-2072-1958 mc2plato@naver.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Wonshik Han    +82-2-2072-1958    hanw@snu.ac.kr   
Contact: Jigwang Jung    +82-2-2072-1958    mc2plato@naver.com   
Principal Investigator: Wonshik Han         
Sub-Investigator: Jigwang Jung         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Wonshik Han Seoul National University Hospital
More Information
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Responsible Party: Wonshik Han, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03900637    
Other Study ID Numbers: PLATO study
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Leuprolide
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal