Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Beijing Huanxing Cancer Hospital
RECRUITING
Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
NOT_YET_RECRUITING
Langfang
Contact Information
Primary
Fei Ma
drmafei@126.com
86-10-87788060
Backup
Hongnan Mo
86-10-87788120
Time Frame
Start Date:2022-03-24
Estimated Completion Date:2027-03-24
Participants
Target number of participants:300
Treatments
Experimental: TNBC with high risk or MRD+
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.
Experimental: HER2+ with high risk or MRD+
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.
Experimental: ER+ with high risk or MRD+
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.
Experimental: TNBC with low risk and MRD-
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.
Experimental: HER2+ with low risk and MRD-
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.
Experimental: ER+ with low risk and MRD-
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.