NCT05345860 Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
| NCT ID | NCT05345860 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Early-stage Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-03-24 |
| Primary Completion | 2024-03-24 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-03-24 with a primary completion date of 2024-03-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Fei Ma
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT05345860 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Early-stage Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05345860 currently recruiting?
Yes, NCT05345860 is actively recruiting participants. Contact the research team at drmafei@126.com for enrollment information.
Where is the NCT05345860 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Langfang, China.
Who is sponsoring the NCT05345860 clinical trial?
NCT05345860 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Fei Ma at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 300 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.