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

Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study

This study is testing if using a new strategy based on minimal residual disease can help improve post-surgery treatment for early-stage breast cancer patients by giving more intensive therapy to those at higher risk.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT05345860 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with resectable early-stage invasive breast cancer who have not yet received systemic therapy.

Not a fit: Patients with other aggressive malignancies or those who have already undergone anti-breast cancer systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment plans for early-stage breast cancer patients.

How similar studies have performed: Other studies utilizing MRD strategies in cancer treatment have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 2 other locations

• 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

Conditions: Early-stage Breast Cancer