A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC

Triple-negative Breast Cancer Clinical Trial

— Apollo  

Official title:

A Prospective, Phase II Trial Using Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501523
• Other study ID #: SunYatsenU2H-LQ3
• Status: Recruiting
• Phase: Phase 2
• Start date: August 3, 2020
• Est. completion date: August 2032

Study information

• Verified date: February 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Shunying Li, MD
• Phone: +86-15915939702
• Email: lishunying[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: August 2032
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration.ER and PR will be considered negative if = 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < 2.0 or < 6 copies per cell.

• Must receive preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include those recommended by NCCN guidelines. Participants who received preoperative therapy as part of a clinical trial may enroll.

• ctDNA positive at baseline, after NAC or after surgery

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

• Written informed consent to provide research blood samples and tumor samples

• Patients must be willing to have frequent blood tests (every 3 months ) and receive a 12 month course of tislelizumab if randomised to tislelizumab treatment on ctDNA detection

• No evidence of distant metastatic disease on staging scans conducted at the time of diagnosis

Exclusion Criteria:

• Previously participated in other interventional trials

• Previous malignancy within 3 years of breast cancer diagnosis

• Pregnancy or breastfeeding

• No written consent

• Unable to receive standard NAC and subsequent radiotherapy(if needed)

• Active autoimmune disease

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer

Intervention

Drug:
• Tislelizumab
200mg, q3w, for 1 year
• capecitabine
600-750 mg/m2 PO Bid,continuous, for 1 year

Locations

Country	Name	City	State
China	Sunyat-sen Memorial Hospital	Guandong	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 years Disease free survival(DFS)	From diagnosis to 5yrs or DFS events; To determine 5-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy	60 months
Secondary	5 years overall survival(OS)	From diagnosis to 5yrs or death; To determine 5-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy	60 months
Secondary	pathological complete remission(pCR) rate	pathological complete remission	12 months
Secondary	brain metastasis rate	The percentage of patients who develop brain metastasis	60 months
Secondary	objective response rate(ORR)	The percentage of patients who achieved PR+CR	12 months
Secondary	Number of Patients with Adverse Events as a Measure of Safety and Tolerability	To determine the toxicities associated with tislelizumab in this population	12 months
Secondary	10 years DFS	To determine 10-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy	120 months
Secondary	10 years OS	To determine 10-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy	120 months
Secondary	Relapse and metastasis rate	The percentage of patients who develop brain metastasis any relapse or metastasis	24 months