The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had previously used CDK4/6 inhibitors.
Participants in this study were hormone-receptor-positive HER2-negative patients with advanced breast cancer who had previously used CDK4/6 inhibitors. Hormone receptor positive HER2 negative was defined as ER positive (IHC ER positive percentage \> 10% or PR positive (IHC PR positive percentage \> 10%) and HER2 negative (IHC-/+; Or IHC++ but FISH/CISH-). The Department of Pathology and the Key Laboratory of Breast Cancer of Fudan University Shanghai Cancer Center conducted digital pathological typing of the biopsy pathology of metastatic lesions of all participants . If the pathology of metastatic lesions could not be obtained, the digital pathological typing was performed according to the pathology of primary lesions. According to the digital pathological types of biopsy tissue and peripheral blood ctDNA, the patients were divided into four precise subtypes: SNF1, SNF2, SNF3, and SNF4. At the same time, the negative control group was randomly set by subtype stratification at 2:1. In different SNF types, patients were divided into 7 subcohorts according to the genetic PANEL results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
620
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGOverall response rate (ORR)
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 3 years)
Clinical Benefit Rate (CBR)
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the subjects
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 3 years
Progression Free Survival (PFS)
time to progressive disease (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 3 years)]
Overall Survival (OS)
time to death due to any cause
Time frame: Randomization to death from any cause, through the end of study (approximately 3 years)
CTCAE scale (V5.0)
To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V5.0)
Time frame: up to One Year during follow-up
Exploration of translational research markers
The collected subjects' tumor tissues, paracancerous tissues, blood, and fecal samples will be used for discovering exploratory biomarkers. The relationships between discovered biomarkers and subjects' disease status and treatment responses will also be investigated.
Time frame: up to One Year during follow-up
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VEGFR inhibitor
PARP inhibitor
CDK4/6 inhibitor
HER2 ADC
mTOR inhibior
Letrozole/Anastrozole/Exemestane or Fulvestrant
For premenopause
Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
RTK Inhibitor
Apatinib 250mg po qd
TROP2 ADC
NECTIN4 ADC
HER3 ADC
PARP1i
CDK4i
bevacizumab