TNBC - Triple-Negative Breast CancerPhase 1/2NCT05928780
An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2)
A Phase 1/2 study testing A1:SG with SHR3680, A2:SG and B1:SG with SHR1210 in people with TNBC - Triple-Negative Breast Cancer, run by Fudan University.
Trial summary
To explore the efficacy and safety of TROP2 in the treatment of ABC Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- A1:SG with SHR3680, A2:SG and B1:SG with SHR1210
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥18 years old and ≤70 years old.
- ECOG body status level 0 ~ 1.
- The expected survival is not less than 3 months.
- Breast cancer patients with histologically proven invasive triple-negative breast cancer (specifically defined as estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) who are all negative by pathological tests. Specifically: ER negative: IHC<1%, PR negative: IHC<1%, HER2 negative: IHC-/+ or IHC++ but FISH/CISH negative. All specimens should be verified by the pathology department of the research center, and the molecular typing of relapses and metastases should be re-checked.
- Tumor stage: recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible.
- Stage II: patients who have not used paclitaxel or have used paclitaxel in adjuvant/neoadjuvant therapy, but the interval from the end of treatment to relapse is greater than 6 months; No systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) has been received in the advanced stage.
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- Stage I: The advanced stage has received ≥1 line systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.).
- Have at least one measurable lesion or unmeasurable lesion according to RECIST version 1.1 (measurable lesion ≥20mm conventional CT scan and ≥10mm spiral CT scan, measurable lesion not receiving radiotherapy).
- The functions of the main organs are basically normal.
- Have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery (except for procedures unrelated to antitumor therapy such as central venous catheterization) within 3 weeks prior to the start of the study, and have recovered from acute toxic effects of previous treatment (if surgery is available, the wound has fully healed).
- No peripheral neuropathy or grade I peripheral neurotoxicity.
- Fertile female subjects are required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug; The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Who cannot join
- Stage II: patients with adjuvant/neoadjuvant use of paclitaxel but the interval from the end of taxol treatment to recurrence and metastasis is less than 6 months, or have received systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) in the late stage;
- Stage I: no systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) has been received in the advanced stage;
- Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastasis, enhanced CT or enhanced Magnetic Resonance Imaging (MRI) must be performed within 28 days before the first dose to rule out central nervous system metastasis.
- A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
- Persistent grade ≥1 adverse events due to previous treatment. The exception to this is hair loss or something the researchers believe should not be ruled out. Such cases should be clearly documented in the investigator's notes;
- Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access);
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- Pregnant or lactating patients;
- Other malignancies within the previous 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma.
- Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect drug use and absorption;
- There is a third space effusion that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites);
- Participated in clinical trials of other antitumor drugs within 4 weeks before taking the study drug for the first time;
- long-term unhealed wounds or incomplete healing fractures;
- Patients with known HBV or HCV infection active phase or hepatitis B DNA≥500, or chronic phase with abnormal liver function;
- Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
- Malignant tumors within the past five years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
About this study
Official title: A Molecular Pathway-based Umbrella Trial for First-line Precision Therapy With TROP2 in Patients With Locally Advanced or Metastatic TNBC (Future-Trop2 Study)
To explore the efficacy and safety of TROP2 in the treatment of ABC
Read the detailed description
To explore the efficacy and safety of advanced first-line TROP2 precision therapy in patients with locally advanced or metastatic triple-negative breast cancer based on molecular subtypes
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- A1:SG with SHR3680, A2:SG, B1:SG with SHR1210, B2:SG, C1:SG with SHR3162
- 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:SG with SHR3680Drug
SG 10mg/kg d1, 8；SHR3680 240mg qd，3 weeks is a cycle
A2:SGDrug
SG 10mg/kg d1, 8
B1:SG with SHR1210Drug
SG 10mg/kg， d1, 8；SHR1210 200mg，d1，q3w；
B2:SGDrug
SG 10mg/kg， d1, 8
C1:SG with SHR3162Drug
Also called Phase Ib dose ramp
SG 10mg/kg d1, 8；SHR3162，150mg，QD ，3 weeks is a cycle
C2:SGDrug
SG 10mg/kg d1, 8
D1:SG with VEGFRIDrug
Also called Phase Ib dose ramp
SG 10mg/kg，d1, 8；BP102 15mg/kg，d1，3 weeks is a cycle
D2:SGDrug
SG 10mg/kg d1, 8
| Study group | Role | What they receive |
|---|---|---|
| LAR | Experimental | Coelomofacial androgen receptor Receives: Drug: A1:SG with SHR3680; Drug: A2:SG |
| IM | Experimental | Immunoregulatory type Receives: Drug: B1:SG with SHR1210; Drug: B2:SG |
| BLIS | Experimental | Basal type and immunosuppressive type Receives: Drug: C1:SG with SHR3162; Drug: C2:SG |
| MES | Experimental | Interstitial type Receives: Drug: D1:SG with VEGFRI; Drug: D2:SG |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
time to progressive disease (according to RECIST1.1)
Measured: max 6 months
Secondary outcomes (3)
OS
Overall survival
Measured: max 6 months
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Measured: max 6 months
DOR
Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
Measured: max 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928780
- Sponsor's protocol ID
- Future-Trop2
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Molecular Pathway-based Umbrella Trial for First-line Precision Therapy With TROP2 in Patients With Locally Advanced or Metastatic TNBC (Future-Trop2 Study)
- ClinicalTrials.gov ID
- NCT05928780
- Acronym / sponsor ID
- Future-Trop2
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 3 Jul 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.
To explore the efficacy and safety of TROP2 in the treatment of ABC
Detailed description
To explore the efficacy and safety of advanced first-line TROP2 precision therapy in patients with locally advanced or metastatic triple-negative breast cancer based on molecular subtypes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LAR | Experimental | Drug: A1:SG with SHR3680, Drug: A2:SGCoelomofacial androgen receptor |
| IM | Experimental | Drug: B1:SG with SHR1210, Drug: B2:SGImmunoregulatory type |
| BLIS | Experimental | Drug: C1:SG with SHR3162, Drug: C2:SGBasal type and immunosuppressive type |
| MES | Experimental | Drug: D1:SG with VEGFRI, Drug: D2:SGInterstitial type |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women ≥18 years old and ≤70 years old.
- ECOG body status level 0 ~ 1.
- The expected survival is not less than 3 months.
- Breast cancer patients with histologically proven invasive triple-negative breast cancer (specifically defined as estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) who are all negative by pathological tests. Specifically: ER negative: IHC<1%, PR negative: IHC<1%, HER2 negative: IHC-/+ or IHC++ but FISH/CISH negative. All specimens should be verified by the pathology department of the research center, and the molecular typing of relapses and metastases should be re-checked.
- Tumor stage: recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible.
Key exclusion criteria (15 listed)
- Stage II: patients with adjuvant/neoadjuvant use of paclitaxel but the interval from the end of taxol treatment to recurrence and metastasis is less than 6 months, or have received systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) in the late stage;
- Stage I: no systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) has been received in the advanced stage;
- Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastasis, enhanced CT or enhanced Magnetic Resonance Imaging (MRI) must be performed within 28 days before the first dose to rule out central nervous system metastasis.
- A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
- Persistent grade ≥1 adverse events due to previous treatment. The exception to this is hair loss or something the researchers believe should not be ruled out. Such cases should be clearly documented in the investigator's notes;
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:SG with SHR3680SG 10mg/kg d1, 8；SHR3680 240mg qd，3 weeks is a cycle | Drug | LAR |
| A2:SGSG 10mg/kg d1, 8 | Drug | LAR |
| B1:SG with SHR1210SG 10mg/kg， d1, 8；SHR1210 200mg，d1，q3w； | Drug | IM |
| B2:SGSG 10mg/kg， d1, 8 | Drug | IM |
| C1:SG with SHR3162Also: Phase Ib dose rampSG 10mg/kg d1, 8；SHR3162，150mg，QD ，3 weeks is a cycle | Drug | BLIS |
| C2:SGSG 10mg/kg d1, 8 | Drug | BLIS |
| D1:SG with VEGFRIAlso: Phase Ib dose rampSG 10mg/kg，d1, 8；BP102 15mg/kg，d1，3 weeks is a cycle | Drug | MES |
| D2:SGSG 10mg/kg d1, 8 | Drug | MES |
Primary outcome
PFS
Time frame: max 6 months
time to progressive disease (according to RECIST1.1)
3 secondary outcomes
OS
Time frame: max 6 months
ORR
Time frame: max 6 months
DOR
Time frame: max 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A1:SG with SHR3680, A2:SG and B1:SG with SHR1210 in people with TNBC - Triple-Negative Breast Cancer, run by Fudan University.
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 12 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: max 6 months). 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 3 Jul 2023.