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

Not Applicable

Recruiting

• Conditions: Early-stage Breast Cancer
• Interventions: Other: The MRD strategy for high risk or MRD+ TNBC patients; Other: The MRD strategy for high risk or MRD+ ER+ patients; Other: The MRD strategy for low risk and MRD- ER+ patients; Other: The MRD strategy for high risk or MRD+ HER2+ patients; Other: The MRD strategy for low risk and MRD- TNBC patients; Other: The MRD strategy for low risk and MRD- HER2+ patients

• Registration Number: NCT05345860
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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 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.

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.

Study Timeline

• Study Start: 2022-03-24
• Status Verified: 2022-04
• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-21
• Last Update Submitted: 2022-04-21
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26
• Primary Completion: 2024-03-24
• Study Completion: 2027-03-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNBC with high risk or MRD+	The MRD strategy for high risk or MRD+ TNBC patients	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.
ER+ with high risk or MRD+	The MRD strategy for high risk or MRD+ ER+ patients	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.
ER+ with low risk and MRD-	The MRD strategy for low risk and MRD- ER+ patients	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.
HER2+ with high risk or MRD+	The MRD strategy for high risk or MRD+ HER2+ patients	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.
TNBC with low risk and MRD-	The MRD strategy for low risk and MRD- TNBC patients	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.
HER2+ with low risk and MRD-	The MRD strategy for low risk and MRD- HER2+ patients	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.

Primary Outcome Measures

Name	Time	Method
3 years disease free survival(DFS)	From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months	the period after curative treatment \[disease eliminated\] when no disease can be detected

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Up to 5 years	The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.
5 years disease free survival(DFS)	From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months	the period after curative treatment \[disease eliminated\] when no disease can be detected
1 years disease free survival(DFS)	From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months	the period after curative treatment \[disease eliminated\] when no disease can be detected
Overall Survival(OS)	From date of radical surgery until the date of death from any cause, assessed up to 60 months	OS was defined as the time from the date of radical surgery to the date of death from any cause
quality of life (QoL)	Up to 5 years	QoL measurement is additionally conducted in the hospital after treatment via digital questionnaire Functional Assessment of Cancer Therapy - Breast (FACT-B) on a tablet computer.

Trial Locations

Locations (3)

Beijing Huanxing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center; 🇨🇳 Langfang, Hebei, China