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

NCT03900637 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: PLATO study
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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)

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Conversion Rate

  Evaluate the conversion rate from BCS-ineligible to BCS-eligible patients

  4 months(maximum 6 months)

Secondary Outcomes (4)

• Actual Conversion Rate

  4 months(maximum 6 months)

• pCR

  4 months(maximum 6 months)

• cCR

  4 months(maximum 6 months)

• Tumor Size Reduction Rate

  4 months(maximum 6 months)

Other Outcomes (3)

• DFS

  5 years

• IBTR

  5 years

• Blueprint subtype

  4 months(maximum 6 months)

Study Arms (1)

Arm I

EXPERIMENTAL

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; Drug: Letrozole; Genetic: MammaPrint

Interventions

Leuprorelin acetate DRUG

In premenopausal women, 3.75mg of leuprorelin acetate is subcutaneously administered once every 4 weeks for 16 weeks. (if needed, maximum for 24 weeks)

Also known as: Leuplin

Arm I

Letrozole DRUG

2.5 mg tablet is orally administered once a day, without regard to meals, for 16 weeks (if needed, maximum for 24 weeks)

Also known as: Lenara, Bretra

Arm I

MammaPrint GENETIC

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.

Arm I

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically and immunohistochemically confirmed ER+ and HER2- BC patients
• Stage I-IIIA BC patients with detectable tumor sizes
• BC patients for whom BCS is not feasible due to tumor sizes or locations (two surgeons at each institution evaluate the infeasibility of BCS)
• Patients without distant metastasis which were identified pathologically or radiologically
• Female patients ≥ 19 years
• Diagnosis of menopause is defined as no menstruation for 1-year or both ovaries removed surgically
• ECOG 0-2
• Patients with adequate bone marrow function
• Hemoglobin 10 g/dL, ANC 1,500/mm3, Plt 100,000/mm3
• Patients with adequate kidney function
• serum Cr ≤ 1.5 mg/dL
• 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

You may not qualify if:

• History of treatment for ipsilateral BC or breast carcinoma in situ
• Confirmed distant metastasis of BC
• History of cancer other than BC
• Pregnant (positive pregnancy test within a week of enrollment) or breast-feeding patients
• Uncontrolled severe infection
• Psychiatric illness or epilepsy
• Male BC patients
• Inability to understand and willingness to sign a written informed consent
• Mammographic extensive microcalcification
• Multicentral, Bilateral BC
• History of chemotherapy or endocrine therapy on contralateral BC for the past 2 years
• ER-
• HER2+
• Undetectable and unmeasurable primary tumor size

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Leuprolide; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wonshik Han

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 3, 2019
• Study Start: November 8, 2019
• Primary Completion: October 31, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

KR (1)