Breast CancerNEMONCT05800197
Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia
An observational study of Breast Cancer and Neoadjuvant Endocrine Therapy, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Neoadjuvant Endocrine Therapy
- What is being tested?
- Tamoxifen 20mg, Anastrozole 1mg and Letrozole 2.5mg
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 15 Apr 2014to 15 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Artamonova Elena contact
Elena Kovalenko contact
Russia1 site, 1 recruiting
- Recruiting
Blokhin's Russian Cancer Research Center
Moscow, 115478
Tatiana Titova, +79152982811, tatiana.titovadoc@gmail.com
Artamonova Elena
About this study
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.
Read the 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
- Conditions
- Breast Cancer, Neoadjuvant Endocrine Therapy
- Being tested
- Tamoxifen 20mg, Anastrozole 1mg, Letrozole 2.5mg, Goserelin, Triptorelin
- Keywords
- Breast Cancer, Neoadjuvant Endocrine Therapy, postmenopausal women, premenopausal women
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen 20mgDrug
Selective estrogen receptor modulator
Anastrozole 1mgDrug
Aromatase Inhibitor
Letrozole 2.5mgDrug
Aromatase Inhibitor
GoserelinDrug
Gonadotropin Releasing Hormone (GnRH) agonist
TriptorelinDrug
Gonadotropin Releasing Hormone (GnRH) agonist
| Study group | Role | What they receive |
|---|---|---|
| premenopausal women | premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3 Receives: 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 Receives: Drug: Tamoxifen 20mg; Drug: Anastrozole 1mg; Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (4)
clinical response in each treatment arm as defined by clinical and ultrasound examination.
Measured: Up to 5 years
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
Measured: Up to 5 years
the rates of breast conservation therapy with regard to the initially planned surgery
Measured: 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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start15 Apr 2014
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800197
- Sponsor's protocol ID
- 17.03.2023
- Acronym
- NEMO
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia
- ClinicalTrials.gov ID
- NCT05800197
- Acronym / sponsor ID
- NEMO / 17.03.2023
- Conditions
- Breast Cancer, Neoadjuvant Endocrine Therapy
- Keywords
- Breast Cancer, Neoadjuvant Endocrine Therapy, postmenopausal women, premenopausal women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 15 Apr 2014 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premenopausal women | – | Drug: Tamoxifen 20mg, Drug: Anastrozole 1mg, Drug: Letrozole 2.5mg, Drug: Goserelin, Drug: Triptorelinpremenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3 |
| postmenopausal women | – | Drug: Tamoxifen 20mg, Drug: Anastrozole 1mg, Drug: Letrozole 2.5mgpostmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
- 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
Key exclusion criteria (7 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamoxifen 20mgSelective estrogen receptor modulator | Drug | postmenopausal women, premenopausal women |
| Anastrozole 1mgAromatase Inhibitor | Drug | postmenopausal women, premenopausal women |
| Letrozole 2.5mgAromatase Inhibitor | Drug | postmenopausal women, premenopausal women |
| GoserelinGonadotropin Releasing Hormone (GnRH) agonist | Drug | premenopausal women |
| TriptorelinGonadotropin Releasing Hormone (GnRH) agonist | Drug | premenopausal women |
Primary outcome
the number of patients with a Residual Cancer Burden (RCB) 0-I index as a measure of efficacy
Time frame: 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.
4 secondary outcomes
clinical response in each treatment arm as defined by clinical and ultrasound examination.
Time frame: Up to 5 years
Preoperative Endocrine Prognostic Index (PEPI)
Time frame: Up to 5 years
the rates of breast conservation therapy with regard to the initially planned surgery
Time frame: Up to 5 years
Disease-free survival (DFS)
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No. Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Artamonova Elena contact
Elena Kovalenko contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Neoadjuvant Endocrine Therapy, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Artamonova Elena (+79152982811), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients with a Residual Cancer Burden (RCB) 0-I index as a measure of efficacy (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.