Trial Title:
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
NCT ID:
NCT05594095
Condition:
Breast Neoplasm
Breast Cancer
Hormone Receptor Positive Tumor
HER2-negative Breast Cancer
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Bevacizumab
Everolimus
Sorafenib
Apatinib
Fulvestrant
Goserelin
Fluzoparib
Aromatase Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PIK3CA inhibitor
Description:
PIK3CA inhibitor
Arm group label:
SNF1 1A: PIK3CA mutation
Intervention type:
Drug
Intervention name:
AKT inhibitor
Description:
AKT inhibitor
Arm group label:
SNF1 1B: AKT pathway mutation
Intervention type:
Drug
Intervention name:
Carrelizumab
Description:
Pd-1 mab
Arm group label:
SNF2 2A
Arm group label:
SNF2 2B: HER2 zero
Arm group label:
SNF2 2C:
Arm group label:
SNF2 2D:
Arm group label:
SNF2 2E: HER2 low
Other name:
SHR1210
Intervention type:
Drug
Intervention name:
Famitinib
Description:
VEGFR inhibitor
Arm group label:
SNF2 2A
Arm group label:
SNF2 2C:
Arm group label:
SNF2 2D:
Arm group label:
SNF2 2E: HER2 low
Arm group label:
SNF3 3D:
Arm group label:
SNF4 4C
Arm group label:
SNF4 4F: HER2 low
Arm group label:
SNF4 4G
Arm group label:
SNF4 4H
Intervention type:
Drug
Intervention name:
Fluzoparib
Description:
PARP inhibitor
Arm group label:
SNF3 3A: Stratification of BRCA/PALB2 expression
Arm group label:
SNF3 3B:
Other name:
SHR3162
Intervention type:
Drug
Intervention name:
Dalpiciclib
Description:
CDK4/6 inhibitor
Arm group label:
SNF3 3A: Stratification of BRCA/PALB2 expression
Other name:
SHR6390
Intervention type:
Drug
Intervention name:
SHR-A1811
Description:
HER2 ADC
Arm group label:
SNF1 1E: HER2 LOW
Arm group label:
SNF2 2E: HER2 low
Arm group label:
SNF3 3E: HER2 low
Arm group label:
SNF4 4A: HER2 low
Arm group label:
SNF4 4F: HER2 low
Intervention type:
Drug
Intervention name:
Everolimus
Description:
mTOR inhibior
Arm group label:
SNF1 1C: without above mutation
Arm group label:
SNF1 1D: without above mutation
Arm group label:
SNF1 1E: HER2 LOW
Arm group label:
SNF1 1F: HER2 zero
Intervention type:
Drug
Intervention name:
Aromatase Inhibitors or Fulvestrant
Description:
Letrozole/Anastrozole/Exemestane or Fulvestrant
Arm group label:
SNF1 1A: PIK3CA mutation
Arm group label:
SNF1 1B: AKT pathway mutation
Arm group label:
SNF1 1C: without above mutation
Intervention type:
Drug
Intervention name:
Goserelin
Description:
For premenopause
Arm group label:
SNF1 1A: PIK3CA mutation
Arm group label:
SNF1 1B: AKT pathway mutation
Arm group label:
SNF1 1C: without above mutation
Intervention type:
Drug
Intervention name:
TPC
Description:
Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and
irbribulin)
Arm group label:
SNF1 1D: without above mutation
Arm group label:
SNF2 2A
Arm group label:
SNF3 3B:
Arm group label:
SNF4 4B:
Arm group label:
The control arm
Intervention type:
Drug
Intervention name:
Sorafenib
Description:
RTK Inhibitor
Arm group label:
SNF4 4D
Intervention type:
Drug
Intervention name:
Apatinib
Description:
Apatinib 250mg po qd
Arm group label:
SNF4 4B:
Arm group label:
SNF4 4E
Intervention type:
Drug
Intervention name:
SHR-A1921
Description:
TROP2 ADC
Arm group label:
SNF1 1F: HER2 zero
Arm group label:
SNF2 2B: HER2 zero
Arm group label:
SNF3 3F: HER2 zero
Intervention type:
Drug
Intervention name:
SHR-A2102
Description:
NECTIN4 ADC
Arm group label:
SNF2 2D:
Arm group label:
SNF4 4H
Intervention type:
Drug
Intervention name:
SHR-A2009
Description:
HER3 ADC
Arm group label:
SNF2 2C:
Arm group label:
SNF4 4G
Intervention type:
Drug
Intervention name:
SHR-1167
Description:
PARP1i
Arm group label:
SNF3 3C:
Arm group label:
SNF3 3D:
Arm group label:
SNF3 3E: HER2 low
Arm group label:
SNF3 3F: HER2 zero
Intervention type:
Drug
Intervention name:
SHR-6209
Description:
CDK4i
Arm group label:
SNF3 3C:
Intervention type:
Drug
Intervention name:
bevacizumab
Description:
bevacizumab
Arm group label:
SNF2 2B: HER2 zero
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female aged ≥18 years;
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:
1. Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were
used in the first 3 weeks of treatment, except bisphosphonate (which can be used for
bone metastasis);
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast cancer institute of Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-Ming Shao, MD
Phone:
86-21-641755901105
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Lei Fan, MD
Phone:
86-21-641755901105
Email:
cmchen@medmail.com.cn
Investigator:
Last name:
Zhi-Ming Shao, MD
Email:
Principal Investigator
Investigator:
Last name:
Lei Fan, MD
Email:
Sub-Investigator
Investigator:
Last name:
Wenjuan Zhang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ying Zhou
Email:
Sub-Investigator
Start date:
December 30, 2022
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Northern Jiangsu People's Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
Ningbo Medical Center Lihuili Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai First Maternity and Infant Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai 6th People's Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Collaborator:
Agency:
Nanchang People's Hospital
Agency class:
Other
Collaborator:
Agency:
Liaoning Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Nantong University
Agency class:
Other
Collaborator:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05594095
