Using ctDNA to guide therapy after surgery in triple negative breast cancer

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

This study is testing if checking for tumor DNA in the blood after surgery can help doctors give extra treatment to high-risk patients with triple negative breast cancer to improve their chances of recovery.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: camrelizumab, chemotherapy
• Locations: 1 site (Guandong, Guangdong)
• Trial ID: NCT04803539 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of circulating tumor DNA (ctDNA) as a prognostic marker to identify high-risk patients with stage II-III triple negative breast cancer (TNBC) after they have undergone surgery and adjuvant chemotherapy. Patients with positive ctDNA will receive additional boost therapy with capecitabine, either alone or in combination with camrelizumab and apatinib. The study aims to improve outcomes for these patients by tailoring therapy based on ctDNA results. Blood samples will be collected every three months for five years to monitor ctDNA levels.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage II-III TNBC who test positive for ctDNA after surgery and adjuvant chemotherapy.

Not a fit: Patients with distant metastases or those who have previously received PD1/PDL1 blockage treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence in high-risk TNBC patients.

How similar studies have performed: Other studies have shown promise in using ctDNA as a prognostic tool in cancer treatment, indicating potential success for this approach.

Eligibility criteria

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

Where this trial is running

Guandong, Guangdong

• Sunyat-sen Memorial Hospital — Guandong, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Qiang Liu, PhD — Sunyat-sen Memorial Hospital
• Study coordinator: Shunying Li, MD

Conditions Breast Cancer; stage II-III