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Recruiting NCT04803539

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

Phase II / Phase III Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: capecitabine, capecitabine + camrelizumab + apatinib.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Invasive Disease Free Survival(IDFS) [Time frame: 60 months]
Secondary outcome measures (4)
  • Distant disease-free survival(DDFS) [Time frame: 60 months]
  • Overall Survival [Time frame: 60 months]
  • Brain metastasis rate [Time frame: 60 months]
  • The rate of adverse effects(AEs) [Time frame: 60 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sunyat-sen Memorial Hospital — Guandong

Identifiers

NCT: NCT04803539 · SunYatsenU2H-LQ4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗