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)

NCT04293796 | Recruiting

• 1 other identifier: PetrovRIO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  During the surgery

Study Arms (2)

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.

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.

Procedure: Vacuum-assisted biopsy

Interventions

Vacuum-assisted biopsy PROCEDURE

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.

HER2-positive breast cancer group; TNBC group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (1)

Petr Krivorotko

Saint Petersburg, 197758, Russia

RECRUITING

MeSH Terms

Conditions

Pathologic Complete Response

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Petr Krivorotko, MD,PhD

  N.N. Petrov Research Institute of Oncology

  PRINCIPAL INVESTIGATOR

• Vladimir Semiglazov, Professor

  N.N.Petrov Research Institute of Oncology

  STUDY DIRECTOR

Central Study Contacts

Petr Krivorotko, MD,PhD

CONTACT

+79219597722; dr.krivorotko@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: March 3, 2020
• Study Start: October 8, 2019
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): December 10, 2028
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

RU (1)