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)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

⁃ 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).

Locations
Other Locations
Russian Federation
Petr Krivorotko
RECRUITING
Saint Petersburg
Contact Information
Primary
Petr Krivorotko, MD,PhD
dr.krivorotko@mail.ru
+79219597722
Time Frame
Start Date: 2019-10-08
Estimated Completion Date: 2028-12-10
Participants
Target number of participants: 60
Treatments
Experimental: TNBC group
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.
Experimental: HER2-positive breast cancer group
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.
Related Therapeutic Areas
Sponsors
Leads: N.N. Petrov National Medical Research Center of Oncology

This content was sourced from clinicaltrials.gov

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