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

Sponsor

Blokhin's Russian Cancer Research Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05800197

Collaborator

(none)

300

Enrollment

Location

129.1

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Neoadjuvant Endocrine Therapy	Drug: Tamoxifen 20mg Drug: Anastrozole 1mg Drug: Letrozole 2.5mg Drug: Goserelin Drug: Triptorelin

Detailed Description

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

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia

Actual Study Start Date :

Apr 15, 2014

Anticipated Primary Completion Date :

Aug 15, 2023

Anticipated Study Completion Date :

Jan 15, 2025

Arms and Interventions

Arm	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: Tamoxifen 20mg Selective estrogen receptor modulator Drug: Anastrozole 1mg Aromatase Inhibitor Drug: Letrozole 2.5mg 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: Tamoxifen 20mg Selective estrogen receptor modulator Drug: Anastrozole 1mg Aromatase Inhibitor Drug: Letrozole 2.5mg Aromatase Inhibitor

Arm

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: Tamoxifen 20mg

Selective estrogen receptor modulator

Drug: Anastrozole 1mg

Aromatase Inhibitor

Drug: Letrozole 2.5mg

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: Tamoxifen 20mg

Selective estrogen receptor modulator

Drug: Anastrozole 1mg

Aromatase Inhibitor

Drug: Letrozole 2.5mg

Aromatase Inhibitor

Outcome Measures

Primary Outcome Measures

the number of patients with a Residual Cancer Burden (RCB) 0-I index as a measure of efficacy [Up to 5 years]
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.

Secondary Outcome Measures

clinical response in each treatment arm as defined by clinical and ultrasound examination. [Up to 5 years]
Preoperative Endocrine Prognostic Index (PEPI) [Up to 5 years]
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
the rates of breast conservation therapy with regard to the initially planned surgery [Up to 5 years]
Disease-free survival (DFS) [Up to 5 years]
DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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