Metastatic Triple-negative Breast CancerPhase 2NCT06851299
The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.
A Phase 2 study testing trop2-ADC, ADC +anti-angiogenic drug and ADC + PD1 monoclonal antibody +anti-angiogenic drug in people with Metastatic Triple-negative Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Triple-negative Breast Cancer
- What is being tested?
- trop2-ADC, ADC +anti-angiogenic drug and ADC + PD1 monoclonal antibody +anti-angiogenic drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 29 Feb 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) adult female patients (aged 18-70 years) with metastatic triple negative breast cancer confirmed by pathology or imaging;
- 2) no more than two previous lines of therapy for metastatic disease;
- 3) ECOG performance status ≤2 and expected survival time ≥ 3 months;
- 4) At least one measurable lesion on imaging within 2 weeks before enrollment; Or simple bone metastases;
- 5) Prior treatment-related toxicity at enrollment had to be resolved to NCI CTCAE version 5.0 ≤ grade 1 (excluding alopecia or any other toxicity deemed by the investigator to be of no risk to patient safety)
- 6) adequate bone marrow reserve: a. White blood cell count (WBC) ≥3.0×10^9 / L, b. Neutrophil count (ANC) ≥1.5×10^9 / L, c. Platelet count (PLT) ≥70×10^9 / L
- 7) liver, kidney and heart function tests were basically normal (according to the normal values of the laboratories in the study center) : a. Total bilirubin (TBIL) ≤3× upper limit of normal value (ULN), b. alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤2.5×ULN (≤5xULN in patients with liver metastases), c. Total bilirubin (TBIL) ≤3× upper limit of normal value (ULN), B. alanine aminotransferase and aspartate aminotransferase (Alt /AST) ≤2.5×ULN (≤5xULN in patients with liver metastases). Serum creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥60 ml/min; d. Left ventricular ejection fraction (LVEF) ≥ 55%, e. QTcF(Fridericia correction) ≤ 470 ms.
- 8) understood the study process and volunteered to participate in the study. Informed consent was signed.
Who cannot join
- 1) patients with a known allergy to the active ingredient or other ingredient of the study drug.
- 2) patients with known resistance to trop2-ADC drugs. 、
- 3) receiving radiotherapy, chemotherapy, or endocrine therapy within 4 weeks before enrollment, or participating in any interventional drug clinical trial;
- 4) pregnant or lactating women or women of childbearing age who refused to use effective contraception during the study period.
- 5) patients with severe cardiac disease or discomfort expected to be unable to tolerate chemotherapy, including but not limited to: fatal arrhythmia or higher grade atrioventricular block, unstable angina pectoris, clinically significant valvular heart disease, transmural myocardial infarction on ECG, uncontrolled hypertension;
- 6) any other condition considered by the investigator to be inappropriate for participation in the study, a concomitant disease or condition that could interfere with participation in the study, or any serious medical disorder that could affect the safety of the subject (e.g., uncontrolled heart disease, hypertension, active or uncontrolled infection, active hepatitis B virus infection)；
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 Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China;
Guangzhou, Guangdong, 510000
Professor, 15920589334, zhaojianli1988@126.com
About this study
Official title: Randomized Controlled Clinical Study of Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategies in the Treatment of Advanced Triple-negative Breast Cancer
This is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.
Read the detailed description
This prospective, multicenter, randomized controlled study aims to evaluate the 3-month treatment efficacy (ORR) of three therapeutic strategies-ADC monotherapy, ADC in combination with immunotherapy, and ADC in combination with immunotherapy and anti-angiogenesis-in patients with advanced breast cancer, and to assess potential adverse events related to the treatment regimens. Participants will receive treatment with a Trop-2-targeting ADC drug containing a TOP1 inhibitor (such as Gosituzumab or SKB264), in accordance with the defined protocol. Regular assessments will include imaging, histopathological analysis, and safety monitoring. The objective of this study is to provide novel treatment strategies for triple-negative breast cancer by evaluating the efficacy and safety of trop2-ADC+ immunotherapy + antiangiogenic agents and trop2-ADC+ antiangiogenic agents versus trop2-ADC monotherapy in patients with metastatic triple-negative breast cancer (mTNBC).
- Conditions
- Metastatic Triple-negative Breast Cancer
- Being tested
- trop2-ADC, ADC +anti-angiogenic drug, ADC + PD1 monoclonal antibody +anti-angiogenic drug
- 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.
trop2-ADCDrug
Accept ADC monotherapy
ADC +anti-angiogenic drugDrug
Accept ADC combined with anti-angiogenic drug
ADC + PD1 monoclonal antibody +anti-angiogenic drugDrug
ADC combined with PD1 monoclonal antibody and anti-angiogenic drug
| Study group | Role | What they receive |
|---|---|---|
| Accept ADC monotherapy | Active comparator | Not described Receives: Drug: trop2-ADC |
| Accept ADC combined with anti-angiogenic drug | Experimental | Not described Receives: Drug: ADC +anti-angiogenic drug |
| Receive ADC in combination with PD1 monoclonal antibody and anti-angiogenic drug | Experimental | Not described Receives: Drug: ADC + PD1 monoclonal antibody +anti-angiogenic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate 3 months after treatment (ORR)
Measured: Three months after enrollment
Secondary outcomes (3)
Overall survival (OS)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
living quality
The scores of EORTC-c30 scale were compared before and after enrollment.
Measured: "through study completion, an average of 1 year
Clinical benefit rate
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Triple-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851299
- Sponsor's protocol ID
- SYSKY-2025-007-02
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 28 Feb 2025
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study of Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategies in the Treatment of Advanced Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06851299
- Acronym / sponsor ID
- SYSKY-2025-007-02
- Conditions
- Metastatic Triple-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 28 Feb 2025 (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 prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.
Detailed description
This prospective, multicenter, randomized controlled study aims to evaluate the 3-month treatment efficacy (ORR) of three therapeutic strategies-ADC monotherapy, ADC in combination with immunotherapy, and ADC in combination with immunotherapy and anti-angiogenesis-in patients with advanced breast cancer, and to assess potential adverse events related to the treatment regimens. Participants will receive treatment with a Trop-2-targeting ADC drug containing a TOP1 inhibitor (such as Gosituzumab or SKB264), in accordance with the defined protocol. Regular assessments will include imaging, histopathological analysis, and safety monitoring. The objective of this study is to provide novel treatment strategies for triple-negative breast cancer by evaluating the efficacy and safety of trop2-ADC+ immunotherapy + antiangiogenic agents and trop2-ADC+ antiangiogenic agents versus trop2-ADC monotherapy in patients with metastatic triple-negative breast cancer (mTNBC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Accept ADC monotherapy | Active comparator | Drug: trop2-ADC |
| Accept ADC combined with anti-angiogenic drug | Experimental | Drug: ADC +anti-angiogenic drug |
| Receive ADC in combination with PD1 monoclonal antibody and anti-angiogenic drug | Experimental | Drug: ADC + PD1 monoclonal antibody +anti-angiogenic drug |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1) adult female patients (aged 18-70 years) with metastatic triple negative breast cancer confirmed by pathology or imaging;
- 2) no more than two previous lines of therapy for metastatic disease;
- 3) ECOG performance status ≤2 and expected survival time ≥ 3 months;
- 4) At least one measurable lesion on imaging within 2 weeks before enrollment; Or simple bone metastases;
- 5) Prior treatment-related toxicity at enrollment had to be resolved to NCI CTCAE version 5.0 ≤ grade 1 (excluding alopecia or any other toxicity deemed by the investigator to be of no risk to patient safety)
Key exclusion criteria (6 listed)
- 1) patients with a known allergy to the active ingredient or other ingredient of the study drug.
- 2) patients with known resistance to trop2-ADC drugs. 、
- 3) receiving radiotherapy, chemotherapy, or endocrine therapy within 4 weeks before enrollment, or participating in any interventional drug clinical trial;
- 4) pregnant or lactating women or women of childbearing age who refused to use effective contraception during the study period.
- 5) patients with severe cardiac disease or discomfort expected to be unable to tolerate chemotherapy, including but not limited to: fatal arrhythmia or higher grade atrioventricular block, unstable angina pectoris, clinically significant valvular heart disease, transmural myocardial infarction on ECG, uncontrolled hypertension;
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 |
|---|---|---|
| trop2-ADCAccept ADC monotherapy | Drug | Accept ADC monotherapy |
| ADC +anti-angiogenic drugAccept ADC combined with anti-angiogenic drug | Drug | Accept ADC combined with anti-angiogenic drug |
| ADC + PD1 monoclonal antibody +anti-angiogenic drugADC combined with PD1 monoclonal antibody and anti-angiogenic drug | Drug | Receive ADC in combination with PD1 monoclonal antibody and anti-angiogenic drug |
Primary outcome
Objective response rate 3 months after treatment (ORR)
Time frame: Three months after enrollment
3 secondary outcomes
Overall survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
living quality
Time frame: "through study completion, an average of 1 year
Clinical benefit rate
Time frame: 3 months after enrollment
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 28 Feb 2025.
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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 trop2-ADC, ADC +anti-angiogenic drug and ADC + PD1 monoclonal antibody +anti-angiogenic drug in people with Metastatic Triple-negative Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 8 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 28 Feb 2025. 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 Zhao JL Professor (+86 15920589334, zhaojianli1988@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate 3 months after treatment (ORR) (time frame: Three months after enrollment). 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 28 Feb 2025.