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) (VAB)
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
About this trial
This is an interventional treatment trial 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
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
- 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
Sites / Locations
- Petr KrivorotkoRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
TNBC group
HER2-positive breast cancer 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.
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.