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

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 HE

Trial Details

NCT ID
NCT05345860
Phase
NA
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • The MRD strategy for high risk or MRD+ TNBC patients
  • The MRD strategy for high risk or MRD+ HER2+ patients
  • The MRD strategy for high risk or MRD+ ER+ patients
  • The MRD strategy for low risk and MRD- TNBC patients
  • The MRD strategy for low risk and MRD- HER2+ patients
  • The MRD strategy for low risk and MRD- ER+ patients
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Langfang, Hebei, China|39.52079,116.71471

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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