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Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.
Official title: Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2022-03-24
Completion Date
2027-03-24
Last Updated
2022-04-26
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.
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.
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.
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.
Locations (3)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Huanxing Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
Langfang, Hebei, China