A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC (Artemis)

A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC (Artemis)

Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: capecitabine; Drug: capecitabine + camrelizumab + apatinib

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Shunying Li, MD; Phone Number: 86-020-34071156; Email: lishunying@foxmail.com
• Study Contact Backup: Name: Qiang Liu, PhD; Phone Number: 86-020-34071157; Email: victorlq@hotmail.com

Study Locations

• China
  • Guangdong
    • Guandong, Guangdong, China
      • Recruiting
      • Sunyat-sen Memorial Hospital
      • Contact: shunying Li; Phone Number: +86-15915939702; Email: lishunying@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patient is ≥ 18 years-old at the time of consent to participate this trial
• Stage II - III primary triple negative breast cancer patients(TNBC), TNBC is defined as ER <=1%, PR <=1%；HER2 receptor IHC=1, or IHC=2 and FISH negative.
• positive ctDNA after curative surgery and/or adjuvant chemotherapy
• ECOG 0-2
• If indicated, patient agree to receive adjuvant radiotherapy according to the institutional guidelines
• Patient receives adjuvant chemotherapy according to the NCCN guidelines
• Patient has available tumor tissue from the surgical specimen for next generation sequencing(NCS)
• Patient agrees to give blood samples for ctDNA tests every 3 months in 5 years

Exclusion Criteria:

• Patient has previously received any PD1/PDL1 blockage treatment
• Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
• Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition)
• Patient participates another interventional clinical trial
• Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 3 years before randomization
• Patient with autoimmune disease preventing the use of camrelizumab
• Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Capecitabine; Patients assigned to this group will receive oral capecitabine at a dose of 650 mg/m2 twice a day by mouth for 1 year	Drug: capecitabine; capecitabine is proved to improve 5-year disease-free survival among women with early-stage triple-negative breast cancer who received standard adjuvant treatment(The SYSUCC-001 Randomized Clinical Trial)
Experimental: Capecitabine + Apatinib + Camrelizumab; Patients assigned to this group will receive oral capecitabine at a dose of 650 mg/m2 twice a day, Camrelizumab 200mg intravenously, once every two weeks (Q2W), oral apatinib, 250mg, PO, qd for 1 year	Drug: capecitabine + camrelizumab + apatinib; Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Disease Free Survival(IDFS)	Invasive Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant disease-free survival(DDFS)	Distant Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria	60 months
Overall Survival	Overall Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria	60 months
Brain metastasis rate	Brain metastasis rate for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria	60 months
The rate of adverse effects(AEs)	AEs related to apatinib and/or camrelizumab	60 months

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Qiang Liu, PhD, Sunyat-sen Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): September 1, 2028
• Study Completion (Anticipated): September 1, 2033

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: stage II-III
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Capecitabine; Apatinib
• Other Study ID Numbers: SunYatsenU2H-LQ4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No