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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
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.
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.
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.
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.
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.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGBeijing Huanxing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
Langfang, Hebei, China
NOT_YET_RECRUITING3 years disease free survival(DFS)
the period after curative treatment \[disease eliminated\] when no disease can be detected
Time frame: From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
5 years disease free survival(DFS)
the period after curative treatment \[disease eliminated\] when no disease can be detected
Time frame: From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
1 years disease free survival(DFS)
the period after curative treatment \[disease eliminated\] when no disease can be detected
Time frame: From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Overall Survival(OS)
OS was defined as the time from the date of radical surgery to the date of death from any cause
Time frame: From date of radical surgery until the date of death from any cause, assessed up to 60 months
Adverse events (AEs)
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.
Time frame: Up to 5 years
quality of life (QoL)
QoL measurement is conducted in the hospital after treatment via digital questionnaire EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) on a tablet computer.
Time frame: Up to 5 years
quality of life (QoL)
QoL measurement is additionally conducted in the hospital after treatment via digital questionnaire Functional Assessment of Cancer Therapy - Breast (FACT-B) on a tablet computer.
Time frame: Up to 5 years
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