Breast Cancer
Conditions
Keywords
stage II-III
Brief 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.
Interventions
DRUGcapecitabine
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)
DRUGcapecitabine + camrelizumab + apatinib
Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive Disease Free Survival(IDFS) | 60 months | Invasive Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain metastasis rate | 60 months | Brain metastasis rate for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria |
| Distant disease-free survival(DDFS) | 60 months | Distant Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria |
| Overall Survival | 60 months | Overall Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria |
| The rate of adverse effects(AEs) | 60 months | AEs related to apatinib and/or camrelizumab |
Countries
China
Contacts
Primary ContactShunying Li, MD
Backup ContactQiang Liu, PhD
Outcome results
None listed