Actively Recruiting
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2022-04-26
300
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
Sponsors
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead Sponsor
B
Beijing Huanxing Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of minimal residual disease (MRD) testing to optimize post-surgery adjuvant therapies for early-stage breast cancer. This prospective, multi-center, open-label cohort study focuses on breast cancer patients classified into three groups: triple-negative (TNBC), HER2 positive (HER2+), and estrogen receptor positive (ER+). The main goal is to improve 3-year disease-free survival by adjusting treatments based on MRD status and clinical risk. The study assigns patients to treatment groups according to their cancer subtype, clinical risk, and MRD test results after surgery. Patients with high clinical risk or positive MRD receive more intensive adjuvant therapies, while those with low risk and negative MRD receive standard treatments. Treatment regimens are personalized and adjusted every three months depending on changes in MRD status. Examples include chemotherapy combined with targeted therapies or endocrine therapies, tailored to each subgroup's needs. Participants will undergo MRD testing using personalized tumor-informed panels and receive standard guideline-based therapies. Follow-up occurs every three months to monitor MRD status and adjust treatment accordingly. Researchers will assess outcomes including 1-, 3-, and 5-year disease-free survival, overall survival, adverse events, and quality of life for up to five years. The study aims to provide detailed data on how MRD-guided therapy adjustments impact long-term patient outcomes after surgery.
CONDITIONS
Brief Title
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged 18 years or older
- Histologically confirmed, resectable invasive breast cancer without metastasis (stage I-III)
- No previous anti-breast cancer systemic therapy received
- Planning to undergo surgery and systemic therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate organ function including bone marrow, liver, and kidney as defined by specified lab values
- Voluntarily signed informed consent form
You will not qualify if you...
- History of other aggressive malignant tumors requiring systemic treatment within past 5 years (except certain treated skin or cervical cancers)
- History of neurological or mental disorders such as epilepsy, dementia, or drug abuse
- Known allergy to study drug components, immunodeficiency, or organ transplantation
- Serious concomitant diseases affecting safety or study completion, like serious infections or uncontrolled chronic diseases
- Pregnancy or lactation
- Any condition deemed by investigator to make participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Ongoing after surgery with adjustments during follow-up
Participants receive standard adjuvant therapies tailored by MRD status and risk group, including chemotherapy, targeted therapy, or endocrine therapy as applicable. Therapies may be adjusted every 3 months based on MRD test results.
Visits once every 3 months for therapy assessment and possible adjustment
Duration - Up to 5 years
Participants are monitored for disease progression, survival, adverse events, and quality of life for up to 5 years after surgery.
Regular follow-up visits during the 5-year period
Trial Site Locations
Total: 3 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Beijing Huanxing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
Langfang, Hebei, China
Not Yet Recruiting
Research Team
F
Fei Ma
H
Hongnan Mo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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