Actively Recruiting
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2022-04-26
300
Participants Needed
3
Research Sites
260 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
This study is a prospective, multi-center, open-label cohort study, with 3 years disease free survival(DFS) as the primary endpoint. We optimize post-operation adjuvant therapy for early stage breast cancer based on the MRD strategy: patients with clinical high risk or post-operation 1st MRD tested positive will receive intensive adjuvant therapy, while patients with low clinical risk and post-operation 1st MRD tested negative will receive standard adjuvant therapy, and the treatment regimens will be adjusted every 3 months according to the change of MRD status. About 100 TNBC patients, 100 HER2+ patients, and 100 ER+ patients are planned to be enrolled.
CONDITIONS
Official 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...
- Subjects aged 218 years (inclusive).
- Histologically confirmed, perioperative invasive breast cancer that is resectable without metastasis (stage I-III).
- No anti-breast cancer systemic therapy received, and planning to receive surgery and systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ function including bone marrow, liver, and kidney function as specified.
- Patients voluntarily signed an informed consent form.
You will not qualify if you...
- Known other aggressive malignant tumor progressing or requiring systemic treatment in the past 5 years (except certain skin and in situ cancers treated curatively).
- History of neurological or mental disorders including epilepsy or dementia; history of psychotropic drug or substance abuse.
- Known allergy to drugs in the MRD strategy; history of immunodeficiency or organ transplantation.
- Serious concomitant diseases threatening safety or study completion such as serious infection, liver, cardiovascular, kidney, respiratory diseases, or uncontrolled diabetes or dyslipidemia.
- Female patients who are pregnant or breastfeeding.
- Investigator's judgment that subject is unsuitable for study participation due to other factors.
AI-Screening
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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
CONTACT
H
Hongnan Mo
CONTACT
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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