Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia (NEMO)

Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Neoadjuvant Endocrine Therapy
• Intervention / Treatment: Drug: Letrozole 2.5mg; Drug: Tamoxifen 20mg; Drug: Anastrozole 1mg; Drug: Goserelin; Drug: Triptorelin

Detailed Description

Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia.

Nonrandomized, retrospective clincal trial

Eligible postmenopausal women were treated with tamoxifen 20 mg, exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily before surgery

or

Eligible premenopausal women were treated with tamoxifen 20 mg, exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily in combination with ovarian suppression before surgery

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Artamonova Elena; Phone Number: +79152982811
• Study Contact Backup: Name: Elena Kovalenko

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115478
    • Recruiting
    • Blokhin's Russian Cancer Research Center
    • Contact: Tatiana Titova; Phone Number: +79152982811; Email: tatiana.titovadoc@gmail.com
    • Principal Investigator: Artamonova Elena
    • Sub-Investigator: Kovalenko Elena
    • Sub-Investigator: Titova Tatiana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

premenopausal or menopausal women aged 18 years or older with histologically confirmed of hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) invasive breast cancer T4 Nany or Tany N2-N3

Description

Inclusion Criteria:

Histologically confirmed of hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) invasive breast cancer T4 Nany or Tany N2-N3 premenopausal or menopausal women aged 18 years or older. No evidence of metastasis (M0) No prior hormonal, chemotherapy or radiotherapy is allowed. No breast operation other than biopsy to make diagnosis is allowed.

Postmenopausal women, defined as women meeting any of the following criteria:

Age ≥ 60 years Age ≥ 45 years with amenorrhea ≥ 12 months in the moment of breast cancer diagnosis and an intact uterus Prior bilateral ovariectomy In case previous hysterectomy, follicle stimulating hormone (FSH) and estradiol levels within the postmenopausal range (using local laboratory ranges)* * In patients previously treated with a luteinizing hormone releasing hormone (LH-RH) analogue, the last extended release formulation should have been administered more than 6 months before randomisation, and menses must not have reappeared.

For women of childbearing potential who are sexually active, agreement to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception during and for at least 6 months post-treatment.Eastern Cooperative Oncology Group (ECOG) performance status 0/1/2 No personal history of breast cancer within the last 5 years

Exclusion Criteria:

Patients non-candidate for breast surgery Patients with previously treated breast cancer during the last 5 years or receiving another concomitant anticancer treatment like chemotherapy, immunotherapy, endocrine Patient whose general clinical condition does not consider postponing surgery

Inadequate organ function, evidenced by the following laboratory results:

Absolute neutrophil count <1,500 cells/mm3 Platelet count <100,000 cells/mm3 Hemoglobin <9 g/dL Total bilirubin greater than 1,5 times the upper limit of normal (ULN) (unless the patient has documented Gilbert's syndrome) Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) >2.5 x ULN Serum creatinine >2.0 mg/dL and/or 177 μmol/L clearance creatinine <50mL/min (calculated by Cockcroft-Gault method) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) >1.5 x ULN (unless on therapeutic coagulation) 9. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic > 100 mmHg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication; unstable angina; CHF of New York Heart Association (NYHA) Grade II or higher; or serious cardiac arrhythmia requiring medication.

Patients with a history of long-QT syndrome or documented family history of long-QT syndrome.

QTc >470 12. serum potassium level < LLN 13. Uncontrolled intercurrent illness including but not limited to, known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus or psychiatric illness/social situations that would limit compliance with study requirements.

Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Pregnant or breastfeeding patients

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
premenopausal women; premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3	Drug: Letrozole 2.5mg; Aromatase Inhibitor; Drug: Tamoxifen 20mg; Selective estrogen receptor modulator; Drug: Anastrozole 1mg; Aromatase Inhibitor; Drug: Goserelin; Gonadotropin Releasing Hormone (GnRH) agonist; Drug: Triptorelin; Gonadotropin Releasing Hormone (GnRH) agonist
postmenopausal women; postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3	Drug: Letrozole 2.5mg; Aromatase Inhibitor; Drug: Tamoxifen 20mg; Selective estrogen receptor modulator; Drug: Anastrozole 1mg; Aromatase Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of patients with a Residual Cancer Burden (RCB) 0-I index as a measure of efficacy	Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 6 variables are included in a calculation formula.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative Endocrine Prognostic Index (PEPI)	the preoperative endocrine prognostic index (PEPI)- consisting of the pathological tumor size, pathological node status, Ki67 labeling index, and ER status of residual tumors after NAE	Up to 5 years
Disease-free survival (DFS)	DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause.	Up to 5 years
clinical response in each treatment arm as defined by clinical and ultrasound examination.		Up to 5 years
the rates of breast conservation therapy with regard to the initially planned surgery		Up to 5 years

Collaborators and Investigators

• Sponsor: Blokhin's Russian Cancer Research Center

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2014
• Primary Completion (Anticipated): August 15, 2023
• Study Completion (Anticipated): January 15, 2025

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; postmenopausal women; premenopausal women; Neoadjuvant Endocrine Therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Luteolytic Agents; Letrozole; Goserelin; Tamoxifen; Triptorelin Pamoate; Anastrozole
• Other Study ID Numbers: 17.03.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No