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

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

NCT ID: NCT05800197

Condition: Breast Cancer
Neoadjuvant Endocrine Therapy

Conditions: Official terms:
Breast Neoplasms
Tamoxifen
Letrozole
Anastrozole
Goserelin
Triptorelin Pamoate

Conditions: Keywords:
Breast Cancer
Neoadjuvant Endocrine Therapy
postmenopausal women
premenopausal women

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Drug
Intervention name: Tamoxifen 20mg
Description: Selective estrogen receptor modulator
Arm group label: postmenopausal women
Arm group label: premenopausal women

Intervention type: Drug
Intervention name: Anastrozole 1mg
Description: Aromatase Inhibitor
Arm group label: postmenopausal women
Arm group label: premenopausal women

Intervention type: Drug
Intervention name: Letrozole 2.5mg
Description: Aromatase Inhibitor
Arm group label: postmenopausal women
Arm group label: premenopausal women

Intervention type: Drug
Intervention name: Goserelin
Description: Gonadotropin Releasing Hormone (GnRH) agonist
Arm group label: premenopausal women

Intervention type: Drug
Intervention name: Triptorelin
Description: Gonadotropin Releasing Hormone (GnRH) agonist
Arm group label: premenopausal women

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.

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

Criteria for eligibility:

Study pop:
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

Sampling method: Probability Sample
Criteria:
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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Blokhin's Russian Cancer Research Center

Address:
City: Moscow
Zip: 115478
Country: Russian Federation

Status: Recruiting

Contact:
Last name: Tatiana Titova

Phone: +79152982811
Email: tatiana.titovadoc@gmail.com

Investigator:
Last name: Artamonova Elena
Email: Principal Investigator

Investigator:
Last name: Kovalenko Elena
Email: Sub-Investigator

Investigator:
Last name: Titova Tatiana
Email: Sub-Investigator

Start date: April 15, 2014

Completion date: January 15, 2025

Lead sponsor:
Agency: Blokhin's Russian Cancer Research Center
Agency class: Other

Source: Blokhin's Russian Cancer Research Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05800197