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

NCT05800197 | Unknown DMC

• 1 other identifier: 17.03.2023
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Neoadjuvant Endocrine Therapy

Keywords

Breast Cancer; Neoadjuvant Endocrine Therapy; postmenopausal women; premenopausal women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 rates of breast conservation therapy with regard to the initially planned surgery

  Up to 5 years

• Disease-free survival (DFS)

  Up to 5 years

Study Arms (2)

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; Drug: Anastrozole 1mg; Drug: Letrozole 2.5mg; Drug: Goserelin; Drug: Triptorelin

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; Drug: Anastrozole 1mg; Drug: Letrozole 2.5mg

Interventions

Tamoxifen 20mg DRUG

Selective estrogen receptor modulator

postmenopausal women; premenopausal women

Anastrozole 1mg DRUG

Aromatase Inhibitor

postmenopausal women; premenopausal women

Letrozole 2.5mg DRUG

Aromatase Inhibitor

postmenopausal women; premenopausal women

Goserelin DRUG

Gonadotropin Releasing Hormone (GnRH) agonist

premenopausal women

Triptorelin DRUG

Gonadotropin Releasing Hormone (GnRH) agonist

premenopausal women

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

Blokhin's Russian Cancer Research Center

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Anastrozole; Letrozole; Goserelin; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 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

Central Study Contacts

Artamonova Elena

CONTACT

+79152982811

Elena Kovalenko

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: April 15, 2014
• Primary Completion: August 15, 2023
• Study Completion: January 15, 2025
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)