Breast NeoplasmPhase 2NCT05594095
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
A Phase 2 study testing PIK3CA inhibitor, AKT inhibitor and Carrelizumab in people with Breast Neoplasm and Breast Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm, Breast Cancer, Hormone Receptor Positive Tumor
- What is being tested?
- PIK3CA inhibitor, AKT inhibitor and Carrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2022to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged ≥18 years;
- 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);
- Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
- HR+/HER2- advanced breast cancer patients who had previously received CDK4/6 inhibitor therapy;
- 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);
- The functions of the main organs are basically normal and meet the following conditions:
Show all 11Show fewer
- 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);
- 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;
- ECOG score ≤2, and life expectancy ≥3 months;
- 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;
- Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.
Who cannot join
- 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);
- Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
- 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;
- 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;
- Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Zhi-Ming Shao, MD, 86-21-641755901105, zhimingshao@yahoo.com
Lei Fan, MD, 86-21-641755901105, cmchen@medmail.com.cn
About this study
Official title: Precision Platform Study of HR+/ HER2-advanced Breast Cancer Based on SNF Typing (A Prospective, Open-label, Multi-center, Phase II Platform Study)
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.
Read the 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.
- Conditions
- Breast Neoplasm, Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer, Advanced Breast Cancer
- Being tested
- PIK3CA inhibitor, AKT inhibitor, Carrelizumab, Famitinib, Fluzoparib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIK3CA inhibitorDrug
PIK3CA inhibitor
AKT inhibitorDrug
AKT inhibitor
CarrelizumabDrug
Also called SHR1210
Pd-1 mab
FamitinibDrug
VEGFR inhibitor
FluzoparibDrug
Also called SHR3162
PARP inhibitor
DalpiciclibDrug
Also called SHR6390
CDK4/6 inhibitor
SHR-A1811Drug
HER2 ADC
EverolimusDrug
mTOR inhibior
Aromatase Inhibitors or FulvestrantDrug
Letrozole/Anastrozole/Exemestane or Fulvestrant
GoserelinDrug
For premenopause
TPCDrug
Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin)
SorafenibDrug
RTK Inhibitor
ApatinibDrug
Apatinib 250mg po qd
SHR-A1921Drug
TROP2 ADC
SHR-A2102Drug
NECTIN4 ADC
SHR-A2009Drug
HER3 ADC
SHR-1167Drug
PARP1i
SHR-6209Drug
CDK4i
bevacizumabDrug
bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| SNF1 1A: PIK3CA mutation | Experimental | 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. Receives: Drug: PIK3CA inhibitor; Drug: Aromatase Inhibitors or Fulvestrant; Drug: Goserelin |
| SNF1 1B: AKT pathway mutation | Experimental | 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. Receives: Drug: AKT inhibitor; Drug: Aromatase Inhibitors or Fulvestrant; Drug: Goserelin |
| SNF1 1C: without above mutation | Experimental | 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. Receives: Drug: Everolimus; Drug: Aromatase Inhibitors or Fulvestrant; Drug: Goserelin |
| SNF2 2A | Experimental | Treatment of physician' choice+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib 15mg po qd for 4 weeks as a cycle Receives: Drug: Carrelizumab; Drug: Famitinib; Drug: TPC |
| SNF3 3A: Stratification of BRCA/PALB2 expression | Experimental | Fluzoparib SHR3162 100mg po qd+Dalpiciclib 125mg po qd for 4 weeks as a cycle Receives: Drug: Fluzoparib; Drug: Dalpiciclib |
| SNF4 4A: HER2 low | Experimental | SHR-A1811 Receives: Drug: SHR-A1811 |
| The control arm | Active comparator | Treatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin) Receives: Drug: TPC |
| SNF3 3B: | Experimental | Fluzoparib SHR3162 100 mg qd+Treatment of physician' choice Receives: Drug: Fluzoparib; Drug: TPC |
| SNF4 4B: | Experimental | Apatinib 250mg qd+Treatment of physician' choice Receives: Drug: TPC; Drug: Apatinib |
| SNF1 1D: without above mutation | Experimental | Everolimus 10mg po qd+Treatment of physician' choice Receives: Drug: Everolimus; Drug: TPC |
| SNF1 1E: HER2 LOW | Experimental | Everolimus 10mg po qd+SHR-A1811 Receives: Drug: SHR-A1811; Drug: Everolimus |
| SNF1 1F: HER2 zero | Experimental | Everolimus 10mg po qd+SHR-A1921 Receives: Drug: Everolimus; Drug: SHR-A1921 |
| SNF2 2B: HER2 zero | Experimental | SHR-A1921+Pd-1 mab (Carrelizumab 200mg Q2W)+bevacizumab 7.5mg po ivgt t for 3 weeks as a cycle Receives: Drug: Carrelizumab; Drug: SHR-A1921; Drug: bevacizumab |
| SNF2 2C: | Experimental | HER3 -ADC+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle Receives: Drug: Carrelizumab; Drug: Famitinib; Drug: SHR-A2009 |
| SNF2 2D: | Experimental | Nectin4-ADC+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle Receives: Drug: Carrelizumab; Drug: Famitinib; Drug: SHR-A2102 |
| SNF2 2E: HER2 low | Experimental | SHR-A1811+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle Receives: Drug: Carrelizumab; Drug: Famitinib; Drug: SHR-A1811 |
| SNF3 3C: | Experimental | CDK4i（SHR-6209 PR2D+PARP1i（SHR-1167 PR2D） Receives: Drug: SHR-1167; Drug: SHR-6209 |
| SNF3 3D: | Experimental | PARP1i（SHR-1167 PR2D)+Famitinib 5mg po qd for 4 weeks as a cycle Receives: Drug: Famitinib; Drug: SHR-1167 |
| SNF3 3E: HER2 low | Experimental | PARP1i（SHR-1167 PR2D)+SHR-A1811 for 3 weeks as a cycle Receives: Drug: SHR-A1811; Drug: SHR-1167 |
| SNF3 3F: HER2 zero | Experimental | PARP1i（SHR-1167 PR2D)+SHR-A1921 for 3 weeks as a cycle Receives: Drug: SHR-A1921; Drug: SHR-1167 |
| SNF4 4C | Experimental | Famitinib 20mg po qd Receives: Drug: Famitinib |
| SNF4 4D | Experimental | Sorafenib 0.4g bid Receives: Drug: Sorafenib |
| SNF4 4E | Experimental | Apatinib 500mg qd Receives: Drug: Apatinib |
| SNF4 4F: HER2 low | Experimental | Famitinib+SHR-A1811 for 3 weeks as a cycle Receives: Drug: Famitinib; Drug: SHR-A1811 |
| SNF4 4G | Experimental | Famitinib+HER3-ADC for 3 weeks as a cycle Receives: Drug: Famitinib; Drug: SHR-A2009 |
| SNF4 4H | Experimental | Famitinib+Nectin4-ADC for 3 weeks as a cycle Receives: Drug: Famitinib; Drug: SHR-A2102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Measured: 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)
Secondary outcomes (5)
Clinical Benefit Rate (CBR)
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the subjects
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: up to One Year during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start30 Dec 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, First Hospital of China Medical University, Sun Yat-sen University, First Affiliated Hospital Xi'an Jiaotong University, Chongqing University Cancer Hospital, Northern Jiangsu People's Hospital, Fujian Medical University Union Hospital, Ningbo Medical Center Lihuili Hospital, Shanghai First Maternity and Infant Hospital, Shanghai 6th People's Hospital, Affiliated Hospital of Nantong University, Nanchang Third Hospital, Liaoning Cancer Hospital & Institute, The First Hospital of Jilin University
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594095
- Sponsor's protocol ID
- BCTOP-L-M05
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2022
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Platform Study of HR+/ HER2-advanced Breast Cancer Based on SNF Typing (A Prospective, Open-label, Multi-center, Phase II Platform Study)
- ClinicalTrials.gov ID
- NCT05594095
- Acronym / sponsor ID
- BCTOP-L-M05
- Conditions
- Breast Neoplasm, Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer, Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, First Hospital of China Medical University, Sun Yat-sen University, First Affiliated Hospital Xi'an Jiaotong University, Chongqing University Cancer Hospital, Northern Jiangsu People's Hospital, Fujian Medical University Union Hospital, Ningbo Medical Center Lihuili Hospital, Shanghai First Maternity and Infant Hospital, Shanghai 6th People's Hospital, Affiliated Hospital of Nantong University, Nanchang Third Hospital, Liaoning Cancer Hospital & Institute, The First Hospital of Jilin University
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 26
| Arm | Type | Receives |
|---|---|---|
| SNF1 1A: PIK3CA mutation | Experimental | Drug: PIK3CA inhibitor, Drug: Aromatase Inhibitors or Fulvestrant, Drug: GoserelinPIK3CA 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. |
| SNF1 1B: AKT pathway mutation | Experimental | Drug: AKT inhibitor, Drug: Aromatase Inhibitors or Fulvestrant, Drug: GoserelinAKT 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. |
| SNF1 1C: without above mutation | Experimental | Drug: Everolimus, Drug: Aromatase Inhibitors or Fulvestrant, Drug: GoserelinEverolimus 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. |
| SNF2 2A | Experimental | Drug: Carrelizumab, Drug: Famitinib, Drug: TPCTreatment of physician' choice+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib 15mg po qd for 4 weeks as a cycle |
| SNF3 3A: Stratification of BRCA/PALB2 expression | Experimental | Drug: Fluzoparib, Drug: DalpiciclibFluzoparib SHR3162 100mg po qd+Dalpiciclib 125mg po qd for 4 weeks as a cycle |
| SNF4 4A: HER2 low | Experimental | Drug: SHR-A1811SHR-A1811 |
| The control arm | Active comparator | Drug: TPCTreatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin) |
| SNF3 3B: | Experimental | Drug: Fluzoparib, Drug: TPCFluzoparib SHR3162 100 mg qd+Treatment of physician' choice |
| SNF4 4B: | Experimental | Drug: TPC, Drug: ApatinibApatinib 250mg qd+Treatment of physician' choice |
| SNF1 1D: without above mutation | Experimental | Drug: Everolimus, Drug: TPCEverolimus 10mg po qd+Treatment of physician' choice |
| SNF1 1E: HER2 LOW | Experimental | Drug: SHR-A1811, Drug: EverolimusEverolimus 10mg po qd+SHR-A1811 |
| SNF1 1F: HER2 zero | Experimental | Drug: Everolimus, Drug: SHR-A1921Everolimus 10mg po qd+SHR-A1921 |
| SNF2 2B: HER2 zero | Experimental | Drug: Carrelizumab, Drug: SHR-A1921, Drug: bevacizumabSHR-A1921+Pd-1 mab (Carrelizumab 200mg Q2W)+bevacizumab 7.5mg po ivgt t for 3 weeks as a cycle |
| SNF2 2C: | Experimental | Drug: Carrelizumab, Drug: Famitinib, Drug: SHR-A2009HER3 -ADC+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle |
| SNF2 2D: | Experimental | Drug: Carrelizumab, Drug: Famitinib, Drug: SHR-A2102Nectin4-ADC+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle |
| SNF2 2E: HER2 low | Experimental | Drug: Carrelizumab, Drug: Famitinib, Drug: SHR-A1811SHR-A1811+Pd-1 mab (Carrelizumab 200mg Q2W)+Famitinib for 3 weeks as a cycle |
| SNF3 3C: | Experimental | Drug: SHR-1167, Drug: SHR-6209CDK4i（SHR-6209 PR2D+PARP1i（SHR-1167 PR2D） |
| SNF3 3D: | Experimental | Drug: Famitinib, Drug: SHR-1167PARP1i（SHR-1167 PR2D)+Famitinib 5mg po qd for 4 weeks as a cycle |
| SNF3 3E: HER2 low | Experimental | Drug: SHR-A1811, Drug: SHR-1167PARP1i（SHR-1167 PR2D)+SHR-A1811 for 3 weeks as a cycle |
| SNF3 3F: HER2 zero | Experimental | Drug: SHR-A1921, Drug: SHR-1167PARP1i（SHR-1167 PR2D)+SHR-A1921 for 3 weeks as a cycle |
| SNF4 4C | Experimental | Drug: FamitinibFamitinib 20mg po qd |
| SNF4 4D | Experimental | Drug: SorafenibSorafenib 0.4g bid |
| SNF4 4E | Experimental | Drug: ApatinibApatinib 500mg qd |
| SNF4 4F: HER2 low | Experimental | Drug: Famitinib, Drug: SHR-A1811Famitinib+SHR-A1811 for 3 weeks as a cycle |
| SNF4 4G | Experimental | Drug: Famitinib, Drug: SHR-A2009Famitinib+HER3-ADC for 3 weeks as a cycle |
| SNF4 4H | Experimental | Drug: Famitinib, Drug: SHR-A2102Famitinib+Nectin4-ADC for 3 weeks as a cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female aged ≥18 years;
- 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);
- Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
- HR+/HER2- advanced breast cancer patients who had previously received CDK4/6 inhibitor therapy;
- 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);
Key exclusion criteria (6 listed)
- 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);
- Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
- 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;
- 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;
- Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIK3CA inhibitorPIK3CA inhibitor | Drug | SNF1 1A: PIK3CA mutation |
| AKT inhibitorAKT inhibitor | Drug | SNF1 1B: AKT pathway mutation |
| CarrelizumabAlso: SHR1210Pd-1 mab | Drug | SNF2 2A, SNF2 2B: HER2 zero, SNF2 2C:, SNF2 2D:, SNF2 2E: HER2 low |
| FamitinibVEGFR inhibitor | Drug | SNF2 2A, SNF2 2C:, SNF2 2D:, SNF2 2E: HER2 low, SNF3 3D:, SNF4 4C, SNF4 4F: HER2 low, SNF4 4G, SNF4 4H |
| FluzoparibAlso: SHR3162PARP inhibitor | Drug | SNF3 3A: Stratification of BRCA/PALB2 expression, SNF3 3B: |
| DalpiciclibAlso: SHR6390CDK4/6 inhibitor | Drug | SNF3 3A: Stratification of BRCA/PALB2 expression |
| SHR-A1811HER2 ADC | Drug | SNF1 1E: HER2 LOW, SNF2 2E: HER2 low, SNF3 3E: HER2 low, SNF4 4A: HER2 low, SNF4 4F: HER2 low |
| EverolimusmTOR inhibior | Drug | SNF1 1C: without above mutation, SNF1 1D: without above mutation, SNF1 1E: HER2 LOW, SNF1 1F: HER2 zero |
| Aromatase Inhibitors or FulvestrantLetrozole/Anastrozole/Exemestane or Fulvestrant | Drug | SNF1 1A: PIK3CA mutation, SNF1 1B: AKT pathway mutation, SNF1 1C: without above mutation |
| GoserelinFor premenopause | Drug | SNF1 1A: PIK3CA mutation, SNF1 1B: AKT pathway mutation, SNF1 1C: without above mutation |
| TPCTreatment of Physicians' Choice (albumin-paclitaxel, capecitabine, vinorelbine, and irbribulin) | Drug | SNF1 1D: without above mutation, SNF2 2A, SNF3 3B:, SNF4 4B:, The control arm |
| SorafenibRTK Inhibitor | Drug | SNF4 4D |
| ApatinibApatinib 250mg po qd | Drug | SNF4 4B:, SNF4 4E |
| SHR-A1921TROP2 ADC | Drug | SNF1 1F: HER2 zero, SNF2 2B: HER2 zero, SNF3 3F: HER2 zero |
| SHR-A2102NECTIN4 ADC | Drug | SNF2 2D:, SNF4 4H |
| SHR-A2009HER3 ADC | Drug | SNF2 2C:, SNF4 4G |
| SHR-1167PARP1i | Drug | SNF3 3C:, SNF3 3D:, SNF3 3E: HER2 low, SNF3 3F: HER2 zero |
| SHR-6209CDK4i | Drug | SNF3 3C: |
| bevacizumabbevacizumab | Drug | SNF2 2B: HER2 zero |
Primary outcome
Overall response rate (ORR)
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)
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
5 secondary outcomes
Clinical Benefit Rate (CBR)
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 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 frame: Randomization to death from any cause, through the end of study (approximately 3 years)
CTCAE scale (V5.0)
Time frame: up to One Year during follow-up
Exploration of translational research markers
Time frame: up to One Year during follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PIK3CA inhibitor, AKT inhibitor and Carrelizumab in people with Breast Neoplasm and Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao, M.D (+86-021-64175590 ext. 88807, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.