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

Breast Cancer Clinical Trial

— Artemis  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803539
• Other study ID #: SunYatsenU2H-LQ4
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2021
• Est. completion date: September 1, 2033

Study information

• Verified date: February 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Shunying Li, MD
• Phone: 86-020-34071156
• Email: lishunying[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: September 1, 2033
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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)
• capecitabine + camrelizumab + apatinib
Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall Survival	Overall Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria	60 months
Secondary	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
Secondary	The rate of adverse effects(AEs)	AEs related to apatinib and/or camrelizumab	60 months