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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-15

Study Completion Date

2025-01-15

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Breast Cancer Neoadjuvant Endocrine Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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premenopausal women

premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3

Tamoxifen 20mg

Intervention Type DRUG

Selective estrogen receptor modulator

Anastrozole 1mg

Intervention Type DRUG

Aromatase Inhibitor

Letrozole 2.5mg

Intervention Type DRUG

Aromatase Inhibitor

Goserelin

Intervention Type DRUG

Gonadotropin Releasing Hormone (GnRH) agonist

Triptorelin

Intervention Type DRUG

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

Tamoxifen 20mg

Intervention Type DRUG

Selective estrogen receptor modulator

Anastrozole 1mg

Intervention Type DRUG

Aromatase Inhibitor

Letrozole 2.5mg

Intervention Type DRUG

Aromatase Inhibitor

Interventions

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Tamoxifen 20mg

Selective estrogen receptor modulator

Intervention Type DRUG

Anastrozole 1mg

Aromatase Inhibitor

Intervention Type DRUG

Letrozole 2.5mg

Aromatase Inhibitor

Intervention Type DRUG

Goserelin

Gonadotropin Releasing Hormone (GnRH) agonist

Intervention Type DRUG

Triptorelin

Gonadotropin Releasing Hormone (GnRH) agonist

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No