Optimizing post-surgery treatments for early-stage breast cancer using MRD strategy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multi-center, open-label cohort study aims to enhance post-operative adjuvant therapy for early-stage breast cancer by utilizing the Minimal Residual Disease (MRD) strategy. Patients identified as high risk or MRD positive will receive intensive adjuvant therapy, while those deemed low risk and MRD negative will undergo standard treatment. The study will monitor disease-free survival over three years and adjust treatment regimens every three months based on MRD status changes. Approximately 300 patients across different breast cancer subtypes will be enrolled.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Beijing Huanxing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
  Langfang, Hebei, China Not yet recruiting

Study contacts

• Principal investigator: Fei Ma — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Fei Ma
• Email: drmafei@126.com
• Phone: 86-10-87788060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.