Clinical trial NCT05345860: Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
Official title: Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early-stage Breast Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing Huanxing Cancer Hospital
name: Chinese Academy of Medical Sciences
First posted: 2022-04-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 3 years disease free survival(DFS)
timeFrame: 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
Secondary outcomes:
measure: 5 years disease free survival(DFS)
timeFrame: 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
measure: 1 years disease free survival(DFS)
timeFrame: 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
measure: Overall Survival(OS)
timeFrame: From date of radical surgery until the date of death from any cause, assessed up to 60 months
measure: Adverse events (AEs)
timeFrame: Up to 5 years
measure: quality of life (QoL)
timeFrame: Up to 5 years
measure: quality of life (QoL)
timeFrame: Up to 5 years
Other outcomes:
measure: Time from MRD turning positive until clinical relapse
timeFrame: Up to 5 years
measure: Coincidence rate between MRD continuing positive and clinical relapse
timeFrame: Up to 5 years
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Huanxing Cancer Hospital
state: Beijing
city: Langfang
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
state: Hebei
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Fei Ma
role: PRINCIPAL_INVESTIGATOR
References: