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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Early-stage Breast Cancer

Treatments: Other: The MRD strategy for high risk or MRD+ ER+ patients; Other: The MRD strategy for low risk and MRD- TNBC patients; Other: The MRD strategy for low risk and MRD- ER+ patients; Other: The MRD strategy for low risk and MRD- HER2+ patients; Other: The MRD strategy for high risk or MRD+ TNBC patients; Other: The MRD strategy for high risk or MRD+ HER2+ patients

Study type: Interventional

Funder types: Other

Identifiers

NCT05345860

NCC3397

Details and patient eligibility

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 6 patient groups

TNBC with high risk or MRD+

Experimental group

Description:

TNBC patients with clinical high risk or post-operation 1st MRD tested positive. It's possible that this arm will be divided into many sub-arms considering the different kinds of intensive adjuvant therapies and the adopting of MRD strategy.

Treatment:

Other: The MRD strategy for high risk or MRD+ TNBC patients

HER2+ with high risk or MRD+

Experimental group

Description:

HER2+ patients with clinical high risk or post-operation 1st MRD tested positive. It's possible that this arm will be divided into many sub-arms considering the different kinds of intensive adjuvant therapies and the adopting of MRD strategy.

Treatment:

Other: The MRD strategy for high risk or MRD+ HER2+ patients

ER+ with high risk or MRD+

Experimental group

Description:

ER+ patients with clinical high risk or post-operation 1st MRD tested positive. It's possible that this arm will be divided into many sub-arms considering the different kinds of intensive adjuvant therapies and the adopting of MRD strategy.

Treatment:

Other: The MRD strategy for high risk or MRD+ ER+ patients

TNBC with low risk and MRD-

Experimental group

Description:

TNBC patients with low clinical risk and post-operation 1st MRD tested negative. It's possible that this arm will be divided into many sub-arms considering the different kinds of standard adjuvant therapies and the adopting of MRD strategy.

Treatment:

Other: The MRD strategy for low risk and MRD- TNBC patients

HER2+ with low risk and MRD-

Experimental group

Description:

HER2+ patients with low clinical risk and post-operation 1st MRD tested negative. It's possible that this arm will be divided into many sub-arms considering the different kinds of standard adjuvant therapies and the adopting of MRD strategy.

Treatment:

Other: The MRD strategy for low risk and MRD- HER2+ patients

ER+ with low risk and MRD-

Experimental group

Description:

ER+ patients with low clinical risk and post-operation 1st MRD tested negative. It's possible that this arm will be divided into many sub-arms considering the different kinds of standard adjuvant therapies and the adopting of MRD strategy.

Treatment:

Other: The MRD strategy for low risk and MRD- ER+ patients