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

NARecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

March 24, 2022

Primary Completion Date

March 24, 2024

Study Completion Date

March 24, 2027

Conditions
Early-stage Breast Cancer
Interventions
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."

Trial Locations (3)

100021

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing

Unknown

RECRUITING

Beijing Huanxing Cancer Hospital, Beijing

NOT_YET_RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center, Langfang

All Listed Sponsors
collaborator

Beijing Huanxing Cancer Hospital

OTHER

collaborator

Chinese Academy of Medical Sciences

OTHER

lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER