Refusal of Breast Surgery in Patients With Breast Cancer With a cCR After NST and a Confirmed Pathological Complete Response (pCR) Using VAB and SLNBVABNCT04293796
Refusal of Breast Surgery in Patients With Breast Cancer With a Clinical Complete Response (cCR) After Neoadjuvant Systemic Therapy and a Confirmed Pathological Complete Response (pCR) Using Vacuum-assisted Biopsy (VAB) and Sentinel Lymph Node Biopsy (SLNB)
A study testing Vacuum-assisted biopsy in people with Refusal of Breast Surgery in Patients With Breast Cancer With a cCR After NST and a Confirmed Pathological Complete Response (pCR) Using VAB and SLNB, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
The main goal of the study is to abandon breast surgery in patients with breast cancer with a clinical complete response (cCR) after neoadjuvant systemic therapy and confirmed pCR using Vacuum-assisted biopsy (VAB) and sentinel lymph node biopsy (SLNB). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Refusal of Breast Surgery in Patients With Breast Cancer With a cCR After NST and a Confirmed Pathological Complete Response (pCR) Using VAB and SLNB
- What is being tested?
- Vacuum-assisted biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 8 Oct 2019to 10 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Triple negative breast cancer / HER2-positive breast cancer (ER / PR +/-)
- age> 18 years.
- morphologically confirmed diagnosis of breast cancer, IIA-IIIA stage
- ECOG score 0-1.
- life expectancy of more than 3 months.
- the consent of patients to use reliable methods of contraception throughout the study
- adequate liver and bone marrow function
- the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).
Who cannot join
- Inconsistency with inclusion criteria.
- Conducting earlier any systemic therapy for breast cancer.
- stage 4 cancer
- carrier mutations of the BRCA1 / 2 gene
- severe uncontrolled concomitant chronic diseases or acute diseases
- the presence of a second malignant tumor
- pregnancy or lactation
- acute conditions and complications, which, according to the doctor, interfere with treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Petr Krivorotko
Saint Petersburg, 197758
Petr Krivorotko, MD,PhD, +79219597722, dr.krivorotko@mail.ru
About this study
The main goal of the study is to abandon breast surgery in patients with breast cancer with a clinical complete response (cCR) after neoadjuvant systemic therapy and confirmed pCR using Vacuum-assisted biopsy (VAB) and sentinel lymph node biopsy (SLNB).
Evidence of the high diagnostic accuracy (sensitivity and specificity) of vacuum aspiration biopsy in determining pCR in patients with clinical complete response after neoadjuvant systemic therapy will allow abandoning breast surgery in favor of radiation therapy alone, improving the quality of life of these patients.
Read the detailed description
Vacuum-assisted removal and biopsy of the tumor bed after neoadjuvant systemic therapy (NST) in patients with clinical complete clinical response with a biopsy of sientinel lymph nodes is in the future a modern alternative to the standard, often crippling and traumatic surgical procedures and does not require additional financial costs for the reconstruction of the breast.
There are only two trial visits that are specific to the trial. All other visits will be routine visits.
The first trial visit before NST will take place in order to provide the patient with detailed information on the study, its' aims, the VAB procedure, and its risks. The patient will be asked to sign a form of informed consent.
In the second visit after the NST, VAB planning will be carried out. This visit may vary depending on the patient, the tumor, and the characteristics of the study site. We will provide each test participant with the opportunity to choose the appropriate conditions for the procedure.
The VAB procedure with a sentinel lymph node biopsy will be performed in the operating room Research objectives
- To evaluate the frequency of coincidence of the clinical complete or partial response (cCR and PR) with pathological complete response (pCR).
- To study the frequency of detecting a residual tumor in the mammary gland using a Vacuum-assisted biopsy or another type of core biopsy and / or detection of metastases in regional lymph nodes (sentinel lymph node biopsy) in comparison with a standard pathological study of the surgical material and regional (including sentinel ) lymph nodes.
- To analyze the frequency of false-positive conclusions of a vacuum aspiration biopsy of the tumor bed about the achievement of pathological complete response (pCR) in comparison with a standard pathological study of a surgical material.
- To study the long-term results (local-regional relapse, survival) of surgical treatment of patients with clinical complete response (cCR) after neoadjuvant systemic therapy, including residual disease compared with patients who achieved pathological complete response (pCR).
- To develop an algorithm for treating patients with clinical complete response, with a confirmed pathological complete response using a tumor bed biopsy and targeted biopsy of sentinel lymph nodes (taking into account the initial characteristics: age, stage with TNM, disease subtypes, the presence of a genetic mutation BRCA1 / 2).
Ultrasound guided VAB will be performed on breast cancer patients with clinical complete response (cCR) after NST.
The pathological results of the VAB specimen will be generally categorized as follows:
- Residual tumor cells in VAB specimen (=non-pCR)
- No residual tumor cells in the VAB specimen and VAB representative of former tumor region (="pCR in VAB")
- No residual tumor cells in the VAB specimen but VAB unclear or not representative of former tumor region (=possible sampling error). These VABs are categorized as uninformative for the primary endpoint of the clinical trial.
The results will be compared with the results of a pathological examination of a surgical material.
- Being tested
- Vacuum-assisted biopsy
- Medical subject headings
- Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum-assisted biopsyProcedure or surgery
The vacuum-assisted (7-10G), minimal invasive biopsy (VAB), either guided by ultrasound, after neoadjuvant systemic treatment on patients with clinical complete response on primary breast cancer management we recommend to take at least 12 biopsies with 7-10G needle sizes with sentinel lymph node biopsy.
| Study group | Role | What they receive |
|---|---|---|
| TNBC group | Experimental | A group with TNBC in neoadjuvant therapy will receive 4 cycles of neoadjuvant polychemotherapy according to the AC regimen (doxorubicin 60 mg / m2, cyclophosphamide 600 mg / m2) once every 21 days, then 12 cycles of neoadjuvant polychemotherapy according to the paclitaxel 60-100 mg / m² scheme in 1 day + carboplatin AUC 2 1 p in 7 days. VAB with SLNB and radiation therapy on the remaining breast tissue with cCR and pCR patients. Patients with residual breast cancer undergo standart surgery procedure. Receives: Procedure: Vacuum-assisted biopsy |
| HER2-positive breast cancer group | Experimental | ER + - / HER2 + will receive 4 cycles of neoadjuvant polychemotherapy according to the AC regimen (doxorubicin 60 mg / m2, cyclophosphamide 600 mg / m2) once every 21 days, then docetaxel 75-100 mg / m² on the 1st day + trastuzumab 6 mg / kg (loading dose of 8 mg / kg) on the 1st day + pertuzumab 420 mg (loading dose of 840 mg) on the 1st day; 4 cycles, 1 time in 21 days and surgical treatment. In adjuvant therapy, a group of patients with HER2-positive breast cancer will receive trastuzumab for up to one year and hormone therapy with an antiestrogen (tamoxifen) or aromatase inhibitors in ER + / HER2 + tumors. VAB with SLNB and radiation therapy on the remaining breast tissue with cCR and pCR patients. Patients with residual breast cancer undergo standart surgery procedure. Receives: Procedure: Vacuum-assisted biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
False negative rate of vacuum-assisted biopsy (FNR)
Achieving a false-negative rate (FNR) of less than 15% in the surgical and vacuum-assisted biopsy specimens
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start8 Oct 2019
- Primary completion10 Dec 2027 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refusal of Breast Surgery in Patients With Breast Cancer With a cCR After NST and a Confirmed Pathological Complete Response (pCR) Using VAB and SLNBStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Krivorotko, MD,PhD, Principal investigator, N.N. Petrov Research Institute of OncologyVladimir Semiglazov, Professor, Study director, N.N.Petrov Research Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293796
- Sponsor's protocol ID
- PetrovRIO
- Acronym
- VAB
- Status last verified
- Jun 2022
- First submitted
- 19 Jan 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refusal of Breast Surgery in Patients With Breast Cancer With a Clinical Complete Response (cCR) After Neoadjuvant Systemic Therapy and a Confirmed Pathological Complete Response (pCR) Using Vacuum-assisted Biopsy (VAB) and Sentinel Lymph Node Biopsy (SLNB)
- ClinicalTrials.gov ID
- NCT04293796
- Acronym / sponsor ID
- VAB / PetrovRIO
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 3 Mar 2020 (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.
The main goal of the study is to abandon breast surgery in patients with breast cancer with a clinical complete response (cCR) after neoadjuvant systemic therapy and confirmed pCR using Vacuum-assisted biopsy (VAB) and sentinel lymph node biopsy (SLNB).
Evidence of the high diagnostic accuracy (sensitivity and specificity) of vacuum aspiration biopsy in determining pCR in patients with clinical complete response after neoadjuvant systemic therapy will allow abandoning breast surgery in favor of radiation therapy alone, improving the quality of life of these patients.
Detailed description
Vacuum-assisted removal and biopsy of the tumor bed after neoadjuvant systemic therapy (NST) in patients with clinical complete clinical response with a biopsy of sientinel lymph nodes is in the future a modern alternative to the standard, often crippling and traumatic surgical procedures and does not require additional financial costs for the reconstruction of the breast.
There are only two trial visits that are specific to the trial. All other visits will be routine visits.
The first trial visit before NST will take place in order to provide the patient with detailed information on the study, its' aims, the VAB procedure, and its risks. The patient will be asked to sign a form of informed consent.
In the second visit after the NST, VAB planning will be carried out. This visit may vary depending on the patient, the tumor, and the characteristics of the study site. We will provide each test participant with the opportunity to choose the appropriate conditions for the procedure.
The VAB procedure with a sentinel lymph node biopsy will be performed in the operating room Research objectives
- To evaluate the frequency of coincidence of the clinical complete or partial response (cCR and PR) with pathological complete response (pCR).
- To study the frequency of detecting a residual tumor in the mammary gland using a Vacuum-assisted biopsy or another type of core biopsy and / or detection of metastases in regional lymph nodes (sentinel lymph node biopsy) in comparison with a standard pathological study of the surgical material and regional (including sentinel ) lymph nodes.
- To analyze the frequency of false-positive conclusions of a vacuum aspiration biopsy of the tumor bed about the achievement of pathological complete response (pCR) in comparison with a standard pathological study of a surgical material.
- To study the long-term results (local-regional relapse, survival) of surgical treatment of patients with clinical complete response (cCR) after neoadjuvant systemic therapy, including residual disease compared with patients who achieved pathological complete response (pCR).
- To develop an algorithm for treating patients with clinical complete response, with a confirmed pathological complete response using a tumor bed biopsy and targeted biopsy of sentinel lymph nodes (taking into account the initial characteristics: age, stage with TNM, disease subtypes, the presence of a genetic mutation BRCA1 / 2).
Ultrasound guided VAB will be performed on breast cancer patients with clinical complete response (cCR) after NST.
The pathological results of the VAB specimen will be generally categorized as follows:
- Residual tumor cells in VAB specimen (=non-pCR)
- No residual tumor cells in the VAB specimen and VAB representative of former tumor region (="pCR in VAB")
- No residual tumor cells in the VAB specimen but VAB unclear or not representative of former tumor region (=possible sampling error). These VABs are categorized as uninformative for the primary endpoint of the clinical trial.
The results will be compared with the results of a pathological examination of a surgical material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNBC group | Experimental | Procedure: Vacuum-assisted biopsyA group with TNBC in neoadjuvant therapy will receive 4 cycles of neoadjuvant polychemotherapy according to the AC regimen (doxorubicin 60 mg / m2, cyclophosphamide 600 mg / m2) once every 21 days, then 12 cycles of neoadjuvant polychemotherapy according to the paclitaxel 60-100 mg / m² scheme in 1 day + carboplatin AUC 2 1 p in 7 days. VAB with SLNB and radiation therapy on the remaining breast tissue with cCR and pCR patients. Patients with residual breast cancer undergo standart surgery procedure. |
| HER2-positive breast cancer group | Experimental | Procedure: Vacuum-assisted biopsyER + - / HER2 + will receive 4 cycles of neoadjuvant polychemotherapy according to the AC regimen (doxorubicin 60 mg / m2, cyclophosphamide 600 mg / m2) once every 21 days, then docetaxel 75-100 mg / m² on the 1st day + trastuzumab 6 mg / kg (loading dose of 8 mg / kg) on the 1st day + pertuzumab 420 mg (loading dose of 840 mg) on the 1st day; 4 cycles, 1 time in 21 days and surgical treatment. In adjuvant therapy, a group of patients with HER2-positive breast cancer will receive trastuzumab for up to one year and hormone therapy with an antiestrogen (tamoxifen) or aromatase inhibitors in ER + / HER2 + tumors. VAB with SLNB and radiation therapy on the remaining breast tissue with cCR and pCR patients. Patients with residual breast cancer undergo standart surgery procedure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Triple negative breast cancer / HER2-positive breast cancer (ER / PR +/-)
- age> 18 years.
- morphologically confirmed diagnosis of breast cancer, IIA-IIIA stage
- ECOG score 0-1.
- life expectancy of more than 3 months.
Key exclusion criteria (8 listed)
- Inconsistency with inclusion criteria.
- Conducting earlier any systemic therapy for breast cancer.
- stage 4 cancer
- carrier mutations of the BRCA1 / 2 gene
- severe uncontrolled concomitant chronic diseases or acute diseases
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 |
|---|---|---|
| Vacuum-assisted biopsyThe vacuum-assisted (7-10G), minimal invasive biopsy (VAB), either guided by ultrasound, after neoadjuvant systemic treatment on patients with clinical complete response on primary breast cancer management we recommend to take at least 12 biopsies with 7-10G needle sizes with sentinel lymph node biopsy. | Procedure or surgery | HER2-positive breast cancer group, TNBC group |
Primary outcome
False negative rate of vacuum-assisted biopsy (FNR)
Time frame: During the surgery
Achieving a false-negative rate (FNR) of less than 15% in the surgical and vacuum-assisted biopsy specimens
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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.
Petr Krivorotko, MD,PhD principal investigator
N.N. Petrov Research Institute of Oncology
Vladimir Semiglazov, Professor study director
N.N.Petrov Research Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum-assisted biopsy in people with Refusal of Breast Surgery in Patients With Breast Cancer With a cCR After NST and a Confirmed Pathological Complete Response (pCR) Using VAB and SLNB, run by N.N. Petrov National Medical Research Center of Oncology 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Jun 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petr Krivorotko, MD,PhD (+79219597722, dr.krivorotko@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False negative rate of vacuum-assisted biopsy (FNR) (time frame: During the surgery). 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 15 Jun 2022.