Triple-negative Breast CancerPhase 2NCT05749588
FUSCC Refractory TNBC Platform Study (FUTURE2.0)
A Phase 2 study testing A1: SHR-A1811, A2: SHR-A1811 with Camrelizumab with famitinib and B1: TROP2 ADC in people with Triple-negative Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a Phase II, open-label, Single-center platform study research based on molecular subtypes to explore precision therapy in refractory triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple-negative Breast Cancer
- What is being tested?
- A1: SHR-A1811, A2: SHR-A1811 with Camrelizumab with famitinib and B1: TROP2 ADC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2023to 31 Dec 2028
- 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;
- TNBC invasive breast cancer confirmed by histology (specific definition: ER <1% positive tumor cells by immunohistochemistry are defined as ER negative, PR <1% positive tumor cells are defined as PR negative, 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;
- Progression after at least one prior therapeutic regimens for advanced/metastatic TNBC
- 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:
- Blood routine examination criteria shall meet: HB ≥90 g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 10^9 /L; PLT acuity 75 x 10^9 /L;
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- 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 ≤1, 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
Fudan University Shanghai Cancer Center
Shanghai, 200032
Zhimin Shao, M.D., zhimingshao@yahoo.com
Yin Liu, M.D., liuyinfudan@163.com
About this study
Official title: Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping（(A Phase II, Open-label, Single-center Platform Study）
This is a Phase II, open-label, Single-center platform study research based on molecular subtypes to explore precision therapy in refractory triple-negative breast cancer.
Read the detailed description
This is a Phase II, open-label, Single-center platform study，Based on FUSCC four TNBC subtypes and the results of the previous FUTURE trial, the investigators designed this platform trial, which for combined the TNBC subtyping and genomic sequencing-guided precision targeted therapy for refractory metastatic TNBC patients. In this trial, refractory mTNBC patients eligible for inclusion can be divided into various precision treatment group according to molecular typing and subtyping to evaluate the efficacy and safety of multiple precision targeted treatment. The research therapy arm can be updated with the update of basic translational research in our center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs.
- Conditions
- Triple-negative Breast Cancer
- Being tested
- A1: SHR-A1811, A2: SHR-A1811 with Camrelizumab with famitinib, B1: TROP2 ADC, B2: TROP2 ADC with Camrelizumab, C1: SHR-A1811
- Keywords
- TNBC, Molecular Subtype, Precision Treatment, Platform Study
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A1: SHR-A1811Drug
A1: an anti-HER2 antibody-drug conjugate (ADC)
A2: SHR-A1811 with Camrelizumab with famitinibDrug
Also called SHR-1210
A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)
Camrelizumab: an anti-programmed death-1 (PD-1) antibody
B1: TROP2 ADCDrug
B1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
B2: TROP2 ADC with CamrelizumabDrug
Also called SHR-1210
B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC
Camrelizumab: an anti-programmed death-1 (PD-1) antibody
C1: SHR-A1811Drug
C1: an anti-HER2 antibody-drug conjugate (ADC)
C2: SHR-A1811 with BP102Drug
C2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)
BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
D1: TROP2 ADCDrug
D1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
D2: TROP2 ADC with BP102Drug
D2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC
BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
E1: SHR-A1811Drug
E1: an anti-HER2 antibody-drug conjugate (ADC)
F1: TROP2 ADCDrug
F1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
G1: SHR-A1811Drug
G1: an anti-HER2 antibody-drug conjugate (ADC)
H1: TROP2 ADCDrug
H1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
E2: SHR-A1811 with everolimusDrug
E1: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) everolimus： an mTOR inhibitor
TQB2102 with TQB2868Drug
TQB2102: an anti-HER2 antibody-drug conjugate (ADC) TQB2868: an anti-PD-1/TGF-β bispecific antibody in all-comer TNBC
| Study group | Role | What they receive |
|---|---|---|
| IM/HER2-low | Experimental | If patients were triple-negative breast cancer with IM subtype and HER2-low-positive Receives: Drug: A1: SHR-A1811; Drug: A2: SHR-A1811 with Camrelizumab with famitinib |
| IM/HER2-0 | Experimental | If patients were triple-negative breast cancer with IM subtype and HER2-zero Receives: Drug: B1: TROP2 ADC; Drug: B2: TROP2 ADC with Camrelizumab |
| BLIS / HER2-low | Experimental | If patients were triple-negative breast cancer with BLIS subtype and HER2-low-positive Receives: Drug: C1: SHR-A1811; Drug: C2: SHR-A1811 with BP102 |
| BLIS /HER2-0 | Experimental | If patients were triple-negative breast cancer with BLIS subtype and HER2-zero Receives: Drug: D1: TROP2 ADC; Drug: D2: TROP2 ADC with BP102 |
| LAR / HER2-low | Experimental | If patients were triple-negative breast cancer with LAR subtype and HER2-low-positive Receives: Drug: E1: SHR-A1811; Drug: E2: SHR-A1811 with everolimus |
| LAR /HER2-0 | Experimental | If patients were triple-negative breast cancer with LAR subtype and HER2-zero Receives: Drug: F1: TROP2 ADC |
| MES/ HER2-low | Experimental | If patients were triple-negative breast cancer with MES subtype and HER2-low-positive Receives: Drug: G1: SHR-A1811 |
| MES /HER2-0 | Experimental | If patients were triple-negative breast cancer with MES subtype and HER2-zero Receives: Drug: H1: TROP2 ADC |
| All-Comer/TQB2102 plus TQB2868 | Experimental | Not described Receives: Drug: TQB2102 with TQB2868 |
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 completion of study (approximately 3 years)
Secondary outcomes (5)
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 completion of study (approximately 3 years)
Duration of Response (DoR)
Duration of 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 completion of study(approximately 3 years)
Disease Control Rate (DCR)
The proportion of patients with the best overall response of CR, PR, or stable disease (SD)
Measured: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start30 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative Breast CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749588
- Sponsor's protocol ID
- SCHBCC-N044
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping（(A Phase II, Open-label, Single-center Platform Study）
- ClinicalTrials.gov ID
- NCT05749588
- Acronym / sponsor ID
- SCHBCC-N044
- Conditions
- Triple-negative Breast Cancer
- Keywords
- TNBC, Molecular Subtype, Precision Treatment, Platform Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Mar 2023 (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.
This is a Phase II, open-label, Single-center platform study research based on molecular subtypes to explore precision therapy in refractory triple-negative breast cancer.
Detailed description
This is a Phase II, open-label, Single-center platform study，Based on FUSCC four TNBC subtypes and the results of the previous FUTURE trial, the investigators designed this platform trial, which for combined the TNBC subtyping and genomic sequencing-guided precision targeted therapy for refractory metastatic TNBC patients. In this trial, refractory mTNBC patients eligible for inclusion can be divided into various precision treatment group according to molecular typing and subtyping to evaluate the efficacy and safety of multiple precision targeted treatment. The research therapy arm can be updated with the update of basic translational research in our center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| IM/HER2-low | Experimental | Drug: A1: SHR-A1811, Drug: A2: SHR-A1811 with Camrelizumab with famitinibIf patients were triple-negative breast cancer with IM subtype and HER2-low-positive |
| IM/HER2-0 | Experimental | Drug: B1: TROP2 ADC, Drug: B2: TROP2 ADC with CamrelizumabIf patients were triple-negative breast cancer with IM subtype and HER2-zero |
| BLIS / HER2-low | Experimental | Drug: C1: SHR-A1811, Drug: C2: SHR-A1811 with BP102If patients were triple-negative breast cancer with BLIS subtype and HER2-low-positive |
| BLIS /HER2-0 | Experimental | Drug: D1: TROP2 ADC, Drug: D2: TROP2 ADC with BP102If patients were triple-negative breast cancer with BLIS subtype and HER2-zero |
| LAR / HER2-low | Experimental | Drug: E1: SHR-A1811, Drug: E2: SHR-A1811 with everolimusIf patients were triple-negative breast cancer with LAR subtype and HER2-low-positive |
| LAR /HER2-0 | Experimental | Drug: F1: TROP2 ADCIf patients were triple-negative breast cancer with LAR subtype and HER2-zero |
| MES/ HER2-low | Experimental | Drug: G1: SHR-A1811If patients were triple-negative breast cancer with MES subtype and HER2-low-positive |
| MES /HER2-0 | Experimental | Drug: H1: TROP2 ADCIf patients were triple-negative breast cancer with MES subtype and HER2-zero |
| All-Comer/TQB2102 plus TQB2868 | Experimental | Drug: TQB2102 with TQB2868 |
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;
- TNBC invasive breast cancer confirmed by histology (specific definition: ER <1% positive tumor cells by immunohistochemistry are defined as ER negative, PR <1% positive tumor cells are defined as PR negative, 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;
- Progression after at least one prior therapeutic regimens for advanced/metastatic TNBC
- 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:
Key exclusion criteria (7 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 |
|---|---|---|
| A1: SHR-A1811A1: an anti-HER2 antibody-drug conjugate (ADC) | Drug | IM/HER2-low |
| A2: SHR-A1811 with Camrelizumab with famitinibAlso: SHR-1210A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC) Camrelizumab: an anti-programmed death-1 (PD-1) antibody | Drug | IM/HER2-low |
| B1: TROP2 ADCB1: an Trophoblast cell-surface antigen 2 (TROP2) ADC | Drug | IM/HER2-0 |
| B2: TROP2 ADC with CamrelizumabAlso: SHR-1210B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC Camrelizumab: an anti-programmed death-1 (PD-1) antibody | Drug | IM/HER2-0 |
| C1: SHR-A1811C1: an anti-HER2 antibody-drug conjugate (ADC) | Drug | BLIS / HER2-low |
| C2: SHR-A1811 with BP102C2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC) BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab) | Drug | BLIS / HER2-low |
| D1: TROP2 ADCD1: an Trophoblast cell-surface antigen 2 (TROP2) ADC | Drug | BLIS /HER2-0 |
| D2: TROP2 ADC with BP102D2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab) | Drug | BLIS /HER2-0 |
| E1: SHR-A1811E1: an anti-HER2 antibody-drug conjugate (ADC) | Drug | LAR / HER2-low |
| F1: TROP2 ADCF1: an Trophoblast cell-surface antigen 2 (TROP2) ADC | Drug | LAR /HER2-0 |
| G1: SHR-A1811G1: an anti-HER2 antibody-drug conjugate (ADC) | Drug | MES/ HER2-low |
| H1: TROP2 ADCH1: an Trophoblast cell-surface antigen 2 (TROP2) ADC | Drug | MES /HER2-0 |
| E2: SHR-A1811 with everolimusE1: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) everolimus： an mTOR inhibitor | Drug | LAR / HER2-low |
| TQB2102 with TQB2868TQB2102: an anti-HER2 antibody-drug conjugate (ADC) TQB2868: an anti-PD-1/TGF-β bispecific antibody in all-comer TNBC | Drug | All-Comer/TQB2102 plus TQB2868 |
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 completion 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
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 completion of study (approximately 3 years)
Duration of Response (DoR)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study(approximately 3 years)
Disease Control Rate (DCR)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion 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
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 16 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Zhimin Shao, M.D. principal investigator
Fudan University
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 A1: SHR-A1811, A2: SHR-A1811 with Camrelizumab with famitinib and B1: TROP2 ADC in people with Triple-negative 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 7 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 16 Apr 2026. 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 completion 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 16 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.