NCT05345860

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

Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early-stage Breast Cancer

Interventions

Type	Name	Description
OTHER	The MRD strategy for high risk or MRD+ TNBC patients	Standard adjuvant chemotherapy + additional chemotherapy: * BRCA positive patients: standard adjuvant chemotherapy + olaparib * BRCA negative patients: standard adjuvant chemotherapy + capecitabine In the period of once 3 months follow-up, if MRD remains positive, the additional chemotherapy will be changed for at most once.
OTHER	The MRD strategy for high risk or MRD+ HER2+ patients	Standard adjuvant chemotherapy + intensive targeted therapy: * Neoadjuvant therapy non-pCR patients: standard adjuvant chemotherapy completed+ T-DM1/HP * Neoadjuvant therapy pCR patients: standard adjuvant chemotherapy completed + HP * Adjuvant therapy patients: AC-T/TCb + HP In the period of once 3 months follow-up, if MRD remains positive, the intensive targeted therapy will be changed for at most once.
OTHER	The MRD strategy for high risk or MRD+ ER+ patients	Standard adjuvant chemotherapy + intensive endocrine therapy: * Premenopausal patients: Standard adjuvant chemotherapy followed by OFS + TAM/TOR, OFS + ANA/LET/EXE, or OFS + ANA/LET/EXE + Abemaciclib. * Postmenopausal: Standard adjuvant chemotherapy followed by ANA/LET/EXE + Abemaciclib. In the period of once 3 months follow-up, if MRD remains positive, the intensive endocrine therapy will be changed for at most once.
OTHER	The MRD strategy for low risk and MRD- TNBC patients	Standard adjuvant chemotherapy: AC-T/TC/TCb/AC. In the period of once 3 months follow-up, if MRD turns positive, additional adjuvant therapies listed in "The MRD strategy for high risk or MRD+ TNBC patients "will be added for at most twice.
OTHER	The MRD strategy for low risk and MRD- HER2+ patients	Standard adjuvant chemotherapy + standard targeted therapy: * Neoadjuvant therapy pCR patients: standard adjuvant chemotherapy (AC-T/TC/TCb) completed + H. * Adjuvant therapy patients: AC-T/TC/TCb/wP + H. In the period of once 3 months follow-up, if MRD turns positive, additional adjuvant targeted therapies listed in "The MRD strategy for high risk or MRD+ HER2+ patients "will be added for at most twice.
OTHER	The MRD strategy for low risk and MRD- ER+ patients	Standard adjuvant chemotherapy + standard endocrine therapy: * Premenopausal patients: Standard adjuvant chemotherapy followed by TAM/TOR. * Postmenopausal patients: Standard adjuvant chemotherapy followed by ANA/LET/EXE. In the period of once 3 months follow-up, if MRD turns positive, additional adjuvant endocrine therapies listed in "The MRD strategy for high risk or MRD+ ER+ patients "will be added for at most twice.

Timeline

• Start date: 2022-03-24
• Primary completion: 2024-03-24
• Completion: 2027-03-24
• First posted: 2022-04-26
• Last updated: 2022-04-26

Locations

3 sites across 1 country: China