Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer (AMENDER)

  • STATUS
    Recruiting
  • End date
    Mar 24, 2027
  • participants needed
    300
  • sponsor
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Updated on 12 May 2022

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 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.

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.

Details
Condition Early-stage Breast Cancer
Treatment The MRD strategy for high risk or MRD+ TNBC patients, The MRD strategy for high risk or MRD+ HER2+ patients, The MRD strategy for high risk or MRD+ ER+ patients, The MRD strategy for low risk and MRD- TNBC patients, The MRD strategy for low risk and MRD- HER2+ patients, The MRD strategy for low risk and MRD- ER+ patients
Clinical Study IdentifierNCT05345860
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
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
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