Eliminating Breast Surgery for Triple Negative or HR-/HER2+ Breast Cancer Patients With Clinical Complete Response to Combined Neoadjuvant Chemotherapy and Neoadjuvant Radiotherapy: A Multicenter, Phase 2 Trial (EBCS)
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Female initial treatment patients aged ≥ 18 years and ≤ 70 years old
• ECOG score 0-1
• Clinical T1-2N0 HER2 positive ( HR negative HER2 IHC score of 3+, or 2+and ISH test positive) or triple negative invasive breast cancer
• Left ventricular ejection fraction (LVEF) ≥ 50%
• 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females\<470ms
• The functional level of the main organs must meet the following requirements: blood routine: ANC ≥ 1.5 × 109/L# PLT≥90 × 109/L# Hb≥90 g/L#Blood biochemistry: TBIL ≤ 2.5 × ULN# ALT and AST ≤ 2.5 × ULN# BUN and Cr ≤ 1.5 × ULN#
• For female subjects who have not undergone menopause or surgical sterilization, during the treatment period and during the study treatment
• Agree to abstain or use effective contraceptive methods for at least 2 months after the next administration; .Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up.
Locations
Other Locations
China
Tianjin medical university cancer institute and hospital
RECRUITING
Tianjin
Contact Information
Primary
ZHENGJUN YANG, MD
yangxinpiaoxue001@163.com
8613512891631
Backup
QINGSONG PANG, MD
pangqingsong@tjmuch.com
8618622221203
Time Frame
Start Date:2024-07-25
Estimated Completion Date:2032-06-30
Participants
Target number of participants:200
Treatments
Experimental: Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy
Patients who meet the criteria for enrollment initially receive four cycles of TCb (HP) \* neoadjuvant chemotherapy, followed by neoadjuvant radiotherapy starting from the fifth cycle of TCb (HP) \* neoadjuvant chemotherapy. After completion of six cycles of neoadjuvant chemotherapy, patients underwent breast magnetic resonance imaging. When a patient meets the MRI criteria suggestive of a complete clinical response (cCR), vacuum assisted core biopsy (VACB) targeting the primary lesion is performed under ultrasound or stereotactic guidance. A minimum of six cores, are obtained using a 7-10 G needle. Biopsy specimens are examined by a pathologist to assess the residual tumor and tumor bed. When no tumor or atypical cells are confirmed in the valid VACB specimen, breast and axillary surgery will be omitted.
Collaborators: Taizhou Hospital, The First Affiliated Hospital of Zhengzhou University, Shandong Cancer Hospital and Institute, Tangshan People's Hospital, First Affiliated Hospital of Kunming Medical University, The First Affiliated Hospital of Hainan Medical University, Chongqing University Cancer Hospital
Leads: Tianjin Medical University Cancer Institute and Hospital