Study Results
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Basic Information
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RECRUITING
PHASE2
620 participants
INTERVENTIONAL
2022-12-30
2026-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SNF1 1A: PIK3CA mutation
PIK3CA inhibitors +Aromatase inhibitors(Letrozole/Anastrozole/Exemestane, po, qd, specific dose (letrozole 2.5mg/ day; Anastrozole 1mg/ day, Exemestane 25mg/ day);Or fulvestrant, 500mg ,im, qm, followed by 500mg im 2 weeks after the first dose; Premenopausal: Goserelin 3.6mg IM every 4 weeks.
PIK3CA inhibitor
PIK3CA inhibitor
Aromatase Inhibitors or Fulvestrant
Letrozole/Anastrozole/Exemestane or Fulvestrant
Goserelin
For premenopause
SNF1 1B: AKT pathway mutation
AKT pathway inhibitors +Aromatase inhibitors(Letrozole/Anastrozole/Exemestane, po, qd, specific dose (letrozole 2.5mg/ day; Anastrozole 1mg/ day, Exemestane 25mg/ day);Or fulvestrant, 500mg ,im, qm, followed by 500mg im 2 weeks after the first dose; Premenopausal: Goserelin 3.6mg IM every 4 weeks.
AKT inhibitor
AKT inhibitor
Aromatase Inhibitors or Fulvestrant
Letrozole/Anastrozole/Exemestane or Fulvestrant
Goserelin
For premenopause
SNF1 1C: without above mutation
Everolimus 10mg po qd+Aromatase inhibitors(Letrozole/Anastrozole/Exemestane, po, qd, specific dose (letrozole 2.5mg/ day; Anastrozole 1mg/ day, Exemestane 25mg/ day);Or fulvestrant, 500mg ,im, qm, followed by 500mg im 2 weeks after the first dose; Premenopausal: Goserelin 3.6mg IM every 4 weeks.
Everolimus
mTOR inhibior
Aromatase Inhibitors or Fulvestrant
Letrozole/Anastrozole/Exemestane or Fulvestrant
Goserelin
For premenopause
SNF2 2A
Treatment of physician' choice+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib 15mg po qd for 4 weeks as a cycle
Carrelizumab
Pd-1 mab
Famitinib
VEGFR inhibitor
TPC
Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
SNF3 3A: Stratification of BRCA/PALB2 expression
Fluzoparib SHR3162 100mg po qd+Dalpiciclib 125mg po qd for 4 weeks as a cycle
Fluzoparib
PARP inhibitor
Dalpiciclib
CDK4/6 inhibitor
SNF4 4A: HER2 low
SHR-A1811
SHR-A1811
HER2 ADC
The control arm
Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
TPC
Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
SNF3 3B:
Fluzoparib SHR3162 100 mg qd+Treatment of physician' choice
Fluzoparib
PARP inhibitor
TPC
Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
SNF4 4B:
Apatinib 250mg qd+Treatment of physician' choice
TPC
Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
Apatinib
Apatinib 250mg po qd
SNF1 1D: without above mutation
Everolimus 10mg po qd+Treatment of physician' choice
Everolimus
mTOR inhibior
TPC
Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
SNF1 1E: HER2 LOW
Everolimus 10mg po qd+SHR-A1811
SHR-A1811
HER2 ADC
Everolimus
mTOR inhibior
SNF1 1F: HER2 zero
Everolimus 10mg po qd+SHR-A1921
Everolimus
mTOR inhibior
SHR-A1921
TROP2 ADC
SNF2 2B: HER2 zero
SHR-A1921+Pd-1 mab (Carrelizumab 200mg Q2W)+bevacizumab 7.5mg po ivgt t for 3 weeks as a cycle
Carrelizumab
Pd-1 mab
SHR-A1921
TROP2 ADC
bevacizumab
bevacizumab
SNF2 2C:
HER3 -ADC+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle
Carrelizumab
Pd-1 mab
Famitinib
VEGFR inhibitor
SHR-A2009
HER3 ADC
SNF2 2D:
Nectin4-ADC+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle
Carrelizumab
Pd-1 mab
Famitinib
VEGFR inhibitor
SHR-A2102
NECTIN4 ADC
SNF2 2E: HER2 low
SHR-A1811+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle
Carrelizumab
Pd-1 mab
Famitinib
VEGFR inhibitor
SHR-A1811
HER2 ADC
SNF3 3C:
CDK4i（SHR-6209 PR2D+PARP1i（SHR-1167 PR2D）
SHR-1167
PARP1i
SHR-6209
CDK4i
SNF3 3D:
PARP1i（SHR-1167 PR2D)+Famitinib 5mg po qd for 4 weeks as a cycle
Famitinib
VEGFR inhibitor
SHR-1167
PARP1i
SNF3 3E: HER2 low
PARP1i（SHR-1167 PR2D)+SHR-A1811 for 3 weeks as a cycle
SHR-A1811
HER2 ADC
SHR-1167
PARP1i
SNF3 3F: HER2 zero
PARP1i（SHR-1167 PR2D)+SHR-A1921 for 3 weeks as a cycle
SHR-A1921
TROP2 ADC
SHR-1167
PARP1i
SNF4 4C
Famitinib 20mg po qd
Famitinib
VEGFR inhibitor
SNF4 4D
Sorafenib 0.4g bid
Sorafenib
RTK Inhibitor
SNF4 4E
Apatinib 500mg qd
Apatinib
Apatinib 250mg po qd
SNF4 4F: HER2 low
Famitinib+SHR-A1811 for 3 weeks as a cycle
Famitinib
VEGFR inhibitor
SHR-A1811
HER2 ADC
SNF4 4G
Famitinib+HER3-ADC for 3 weeks as a cycle
Famitinib
VEGFR inhibitor
SHR-A2009
HER3 ADC
SNF4 4H
Famitinib+Nectin4-ADC for 3 weeks as a cycle
Famitinib
VEGFR inhibitor
SHR-A2102
NECTIN4 ADC
Interventions
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PIK3CA inhibitor
PIK3CA inhibitor
AKT inhibitor
AKT inhibitor
Carrelizumab
Pd-1 mab
Famitinib
VEGFR inhibitor
Fluzoparib
PARP inhibitor
Dalpiciclib
CDK4/6 inhibitor
SHR-A1811
HER2 ADC
Everolimus
mTOR inhibior
Aromatase Inhibitors or Fulvestrant
Letrozole/Anastrozole/Exemestane or Fulvestrant
Goserelin
For premenopause
TPC
Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
Sorafenib
RTK Inhibitor
Apatinib
Apatinib 250mg po qd
SHR-A1921
TROP2 ADC
SHR-A2102
NECTIN4 ADC
SHR-A2009
HER3 ADC
SHR-1167
PARP1i
SHR-6209
CDK4i
bevacizumab
bevacizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HR+/HER2- invasive breast cancer confirmed by histology (specific definition: ER \>10% positive tumor cells by immunohistochemistry is defined as ER positive, PR \>10% positive tumor cells is defined as PR positive, ER and/or PR positive is defined as HR positive; HER2 0-1+ or HER2 + but negative by FISH without amplification was defined as HER2 negative);
3. Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
4. HR+/HER2- advanced breast cancer patients who had previously received CDK4/6 inhibitor therapy;
5. At least one measurable lesion according to RECIST 1.1 (conventional CT scan ≥20 mm, spiral CT scan ≥10 mm, measurable lesion has not received radiotherapy);
6. The functions of the main organs are basically normal and meet the following conditions:
I. Blood routine examination criteria shall meet: HB ≥90 g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 109 / L; PLT acuity 75 x 109 / L; Ii. Biochemical tests should meet the following criteria: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
7. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity;
8. ECOG score ≤2, and life expectancy ≥3 months;
9. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;
10. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.
Exclusion Criteria
2. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
3. A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;
4. Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;
5. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
6. Pregnant or lactating patients; Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.
18 Years
FEMALE
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
First Hospital of China Medical University
OTHER
Sun Yat-sen University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Chongqing University Cancer Hospital
OTHER
Northern Jiangsu People's Hospital
OTHER
Fujian Medical University Union Hospital
OTHER
Ningbo Medical Center Lihuili Hospital
OTHER_GOV
Shanghai First Maternity and Infant Hospital
OTHER
Shanghai 6th People's Hospital
OTHER
Affiliated Hospital of Nantong University
OTHER
Nanchang People's Hospital
UNKNOWN
Liaoning Cancer Hospital & Institute
OTHER
The Affiliated Hospital of Nantong University
UNKNOWN
The First Hospital of Jilin University
OTHER
Fudan University
OTHER
Responsible Party
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Zhimin Shao
Professor
Locations
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Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BCTOP-L-M05
Identifier Type: -
Identifier Source: org_study_id
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