Status:
RECRUITING
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Beijing Huanxing Cancer Hospital
Chinese Academy of Medical Sciences
Conditions:
Early-stage Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
MRD will be tested with tumor-informed personalized panel in this trail. The adjuvant therapies in the MRD strategy are all standard therapies in guidelines of China or abroad.
Eligibility Criteria
Inclusion
- Subjects aged ≥18 years (inclusive).
- Histologically confirmed, perioperative invasive breast cancer that is resectable without metastasis(stage I-III).
- No anti-breast cancer systematic therapy received, and planning to receive surgery and systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- With Adequate Organ Function:
- a. Bone marrow function: Hemoglobin ≥ 10 g/dL; Absolute leucocyte count ≥ 4×10\^9/L; Absolute neutrophil count ≥ 1.5×10\^9/L; Platelets ≥ 100 × 10\^9/L; b. Liver function (based on the normal values specified by study site): Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; c. Renal function (based on the normal values specified by study site): Serum creatinine ≤ 1.5 × ULN.
- The patients voluntarily signed an informed consent form.
Exclusion
- Known to have other aggressive malignant tumor that is progressing or requires systemic treatment in the past 5 years (does not exclude subjects with skin basal cell carcinoma, skin squamous cell carcinoma, breast ductal carcinoma in situ or cervical cancer in situ that has received curative treatment).
- Have a clear history of neurological or mental disorders, including epilepsy or dementia, etc.; have a history of psychotropic drug abuse or drug abuse.
- Known history of allergy to the drug components in MRD strategy; history of immunodeficiency, or history of organ transplantation.
- There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
- Female patients during pregnancy or lactation.
- The investigator determines that subjects are not appropriate to participate in the study due to other factors.
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 24 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05345860
Start Date
March 24 2022
End Date
March 24 2027
Last Update
April 26 2022
Active Locations (3)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Beijing Huanxing Cancer Hospital
Beijing, Beijing Municipality, China
3
Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
Langfang, Hebei, China