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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2033-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Molecular Testing and Imaging in Improving Response in Patients With Stage I-III Triple-Negative Breast Cancer Receiving Chemotherapy MDACC Breast Moonshot Initiative

NCT02276443

Invasive Breast Carcinoma Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 +9 more

ACTIVE_NOT_RECRUITING NA

ctDNA in HER2+ EBC Neoadjuvant Treatment

NCT07335081

Breast Cancer

RECRUITING PHASE2

Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

NCT02535221

Breast Cancer

RECRUITING PHASE3

Study of Preoperative Chemotherapy for Early Triple Negative or HER2-positive Operable Breast Cancer

NCT02934828

Breast Cancer

UNKNOWN PHASE2

A Study of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

NCT05426486

HER2-positive Breast Cancer

ACTIVE_NOT_RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

capecitabine

Intervention Type DRUG

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 + 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

Group Type EXPERIMENTAL

capecitabine + camrelizumab + apatinib

Intervention Type DRUG

Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DRUG

capecitabine + camrelizumab + apatinib

Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No