Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast CancerPhase 2NCT06878625
A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer
A Phase 2 study testing Sacituzumab Govitecan combined with Toripalimab and Sacituzumab govitecan combined with anti-angiogenesis in people with Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Research purposes: the research design in the late more than 2 lines TNBC prospective, multicenter, cohort study, respectively to observe Trop2 - ADC joint PD - 1 single or combined anti-angiogenesis drugs (macromolecular single bevacizumab or small molecules TKI resistance, for, as the default layered) the efficacy… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast Cancer
- What is being tested?
- Sacituzumab Govitecan combined with Toripalimab and Sacituzumab govitecan combined with anti-angiogenesis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2024to 30 Jun 2027
- 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
- Aged between 18 and 70 years.
- Histologically confirmed triple-negative invasive breast cancer, defined as immunohistochemical detection of ER < 10%, PR < 10%, HER2 0-1+ or HER2 2+ with negative FISH or CISH results, in accordance with the 2018 ASCO-CAP HER2-negative identification guidelines.
- Patients with locally advanced or metastatic breast cancer who have undergone radical surgery; patients received at least one but no more than two lines of chemotherapy in the advanced treatment phase. Early-stage triple-negative breast cancer patients who experienced disease progression within one year after neoadjuvant or adjuvant therapy are also eligible.
- No prior use of immunotherapy or anti-angiogenic drugs.
- At least one measurable lesion based on RECIST 1.1 criteria.
- No contraindications to chemotherapy, immunotherapy, or anti-angiogenic therapy.
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- Stable or asymptomatic brain metastases are permitted.
- ECOG Performance Status (PS) score of 0-2; predicted survival exceeding 12 weeks.
- All acute toxicities from previous anticancer therapies must have resolved to Grade ≤1 per protocol criteria (excluding alopecia) before screening.
- Women of childbearing potential must agree to use medically approved contraception during treatment and for at least three months post-treatment.
- Adequate organ function, meeting the following criteria: Hemoglobin ≥90 g/L without transfusion within 14 days; Absolute Neutrophil Count (ANC) ≥1.5×10^9/L; Platelets ≥75×10^9/L; Total Bilirubin ≤1.5×ULN; AST and ALT ≤3×ULN (≤5×ULN if liver metastasis present); Serum Creatinine ≤1×ULN; Left Ventricular Ejection Fraction (LVEF) ≥50%.
- Participants were voluntarily enrolled in this study, demonstrated excellent adherence, and actively participated in safety and survival follow-up assessments.
Who cannot join
- Uncontrolled central nervous system metastasis (symptomatic or requiring glucocorticoids or mannitol for symptom management);
- Symptomatic third-space effusions, including pericardial, pleural, and peritoneal effusions, that cannot be adequately managed by drainage or other therapeutic interventions;
- Participation in another clinical trial within 30 days prior to enrollment;
- History of other malignancies within the past 5 years, excluding adequately treated cervical carcinoma in situ, skin squamous cell carcinoma, thyroid carcinoma, or controlled basal cell carcinoma;
- Uncontrolled cardiac conditions, such as: (1) heart failure classified as NYHA class II or higher; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc interval greater than 470 ms;
- Arterial or venous thrombotic events within 24 weeks preceding informed consent, including cerebrovascular accidents (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
Show all 12Show fewer
- Within 24 weeks prior to signing the informed consent form (ICF), a history of any of the following conditions: peptic ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease, diverticulitis, abdominal fistula, tracheoesophageal fistula, or intra-abdominal abscess.
- Presence of factors that significantly impair oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- Patients with a documented history of allergy may have potential hypersensitivity or intolerance to gozzatuzumab, toripalimab, bevacizumab, or anlotinib.
- Active infection with human immunodeficiency virus (HIV), active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥500 IU/ml), or hepatitis C (hepatitis C antibody positive and detectable HCV RNA).
- Pregnant women, lactating women, fertile women with a positive baseline pregnancy test, or women of childbearing age who are unwilling to use effective contraception for the duration of the trial.
- Presence of concomitant diseases (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders) or any other condition that, in the investigator's judgment, could compromise subject safety, confound study results, or prevent subjects from completing the study.
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
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: A Multicenter, Prospective, Cohort Study Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast Cancer
Research purposes: the research design in the late more than 2 lines TNBC prospective, multicenter, cohort study, respectively to observe Trop2 - ADC joint PD - 1 single or combined anti-angiogenesis drugs (macromolecular single bevacizumab or small molecules TKI resistance, for, as the default layered) the efficacy and safety. Indications: Trop2 - ADC joint PD - 1 single or combined anti-angiogenesis drugs (macromolecular single bevacizumab or small molecules TKI resistance, for, as the default layered) treat above 2 late three negative breast cancer (TNBC).
Read the detailed description
- Study Population
- Eligible Participants: Patients with triple - negative metastatic breast cancer at the second line of treatment or higher. Triple - negative invasive breast cancer is histologically confirmed, defined as immunohistochemical detection revealing estrogen receptor (ER) < 10%, progesterone receptor (PR) < 10%, and HER2 0 - 1+ or HER2 2+ with negative fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) results, in accordance with the 2018 ASCO - CAP HER2 - negative identification guidelines.
- Experimental Design
- Study Type: Multicenter, prospective cohort study.
- Sample Size Determination
- The sample size is calculated based on the primary endpoint of progression - free survival (PFS). Drawing on data from ASCENT (a confirmatory phase III study on the efficacy in triple - negative breast cancer) and EVER - 132 - 001 (a Chinese population bridging study presented at the ESMO Congress), the PFS of sacituzumab govitecan monotherapy in metastatic triple - negative breast cancer (mTNBC) is approximately 5.6 months.
- Assuming a hazard ratio of 0.70 in each cohort (median PFS value of 8 months vs. 5.6 months), to detect a statistically significant difference between the trial group and the sacituzumab govitecan monotherapy control group at a one - sided significance level of 0.05 and a power of 80%, 51 PFS events are required. Given an enrollment period of 18 months and a total study duration of 30 months, 69 subjects are needed for each cohort.
- Dosage Regimens
- 4.1 Sacituzumab Govitecan Dose and Administration: The recommended dose is 10 mg/kg. It is administered by intravenous infusion on days 1 and 8 of each treatment cycle, with each cycle lasting three weeks.
- 4.2 Toripalimab Dose and Administration: 240 mg is administered by intravenous infusion on day 1 of each cycle. Each treatment cycle has a duration of three weeks.
- 4.3 Antiangiogenic Targeted Drugs Options and Dosage: Bevacizumab or Anlotinib can be selected. Treatment is carried out according to the standard dosage for each respective drug.
- Inclusion Criteria
- Age between 18 and 70 years.
- Histologically - confirmed triple - negative invasive breast cancer as per the defined immunohistochemical and molecular criteria.
- For patients with locally advanced or metastatic breast cancer: Those who have undergone radical surgery. Those who have received at least one but no more than two lines of chemotherapy in the advanced treatment phase. Additionally, early - stage triple - negative breast cancer patients who experienced disease progression within one year after neoadjuvant or adjuvant therapy are eligible.
- No prior use of immunotherapeutic drugs or anti - angiogenic drugs.
- At least one measurable lesion as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- No contraindications to chemotherapy, immunotherapy, or anti - angiogenic therapy.
- Permitted to have stable or asymptomatic brain metastases.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 - 2, with a predicted survival exceeding 12 weeks.
- All acute toxicities from previous anticancer therapies must have resolved to Grade ≤1 according to the protocol criteria (excluding alopecia) before screening.
- Women of childbearing potential must agree to use medically approved contraception during treatment and for at least three months post - treatment.
- Adequate organ function meeting the following criteria: Hemoglobin ≥ 90 g/L without transfusion within 14 days. Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L. Platelets ≥ 75×10⁹/L. Total Bilirubin ≤ 1.5× the upper limit of normal (ULN). Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3×ULN (≤ 5×ULN if liver metastasis is present). Serum Creatinine ≤ 1×ULN. Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
- Participants must voluntarily enroll in the study, demonstrate excellent adherence, and actively participate in safety and survival follow - up assessments.
- Exclusion Criteria
- Uncontrolled central nervous system metastases (symptomatic or requiring glucocorticoids or mannitol for symptom management).
- Symptomatic third - space effusions, including pericardial, pleural, and peritoneal effusions, that cannot be adequately managed by drainage or other therapeutic interventions.
- Participation in another clinical trial within 30 days prior to enrollment. History of other malignancies within the past 5 years, excluding adequately treated cervical carcinoma in situ, skin squamous cell carcinoma, thyroid carcinoma, or controlled basal cell carcinoma.
- Uncontrolled cardiac conditions, including:
- Heart failure classified as NYHA class II or higher.
- Unstable angina.
- Myocardial infarction within the past year.
- Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- QTc interval greater than 470 ms.
- Arterial or venous thrombotic events within 24 weeks preceding informed consent, such as cerebrovascular accidents (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
- Within 24 weeks prior to signing the informed consent form (ICF), a history of any of the following conditions: peptic ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease, diverticulitis, abdominal fistula, tracheoesophageal fistula, or intra - abdominal abscess. Presence of factors that significantly impair oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- Documented history of allergy with potential hypersensitivity or intolerance to sacituzumab govitecan, toripalimab, bevacizumab, or anlotinib.
- Active human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥ 500 IU/ml), or hepatitis C (hepatitis C antibody positive and detectable HCV RNA).
- Pregnant women, lactating women, fertile women with a positive baseline pregnancy test, or women of childbearing age who are unwilling to use effective contraception for the duration of the trial.
- Presence of concomitant diseases (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders) or any other condition that, in the investigator's judgment, could compromise subject safety, confound study results, or prevent subjects from completing the study.
- Efficacy Endpoints
- 7.1 Primary Endpoint Progression - free survival (PFS).
- 7.2 Secondary Endpoints Objective response rate (ORR). Overall survival (OS). Safety evaluation. Duration of response (DOR). Clinical benefit rate (DCR). Biomarker studies.
- Efficacy is evaluated every two cycles. For treatments showing effectiveness (at least 4 to 6 cycles), immunotherapy or targeted therapy can be continued.
- Safety Indicators
- Adverse events are recorded from the time of completion or signing of the informed consent until the end of the study period as determined by the researchers. All adverse events occurring during this period are to be documented.
- Statistical Methods
- 9.1 General Data Summarization：Unless otherwise specified, data will be summarized using descriptive statistical methods. For measurement data, the mean, standard deviation, median, maximum, and minimum values will be reported. For count data, frequencies and percentages will be used for summarization.
- 9.2 Survival Analysis：The Kaplan - Meier method will be employed to estimate survival rates and plot survival curves for time - to - event data, such as PFS and DOR.
- 9.3 Blood Concentration Data：Blood concentration data will be summarized using the geometric mean, geometric standard deviation, geometric coefficient of variation, mean, standard deviation, coefficient of variation, median, maximum, and minimum values.
- 9.4 Effectiveness Analysis： Effectiveness analysis will be based on the full analysis set (FAS) and the per - protocol set (PPS).The objective response rate (ORR) will be descriptively statistically analyzed according to the stage and dose groups. The number and proportion of subjects with a response (complete response (CR)+partial response (PR)) will be provided, and a two - sided 95% exact confidence interval for the overall ORR will be estimated.PFS and DOR, being time - to - event data, will be analyzed using the Kaplan - Meier method to plot survival curves and estimate the median survival time. When necessary, the two - sided 95% confidence interval for the overall median survival time will be estimated.The clinical benefit rate (DCR) will provide the number and proportion of subjects identified as CR + PR+stable disease (SD), and when necessary, a two - sided 95% exact confidence interval for the DCR will be estimated.
- 9.5 Safety Analysis：Safety analysis will be based on the safety set (actual drug categories). It is limited to summary descriptive statistics.
- Conditions
- Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast Cancer
- Being tested
- Sacituzumab Govitecan combined with Toripalimab, Sacituzumab govitecan combined with anti-angiogenesis
- Keywords
- Sacituzumab govitecan, triple negative breast cancer, PD-1 monoclonal antibody, anti-angiogenesis
- 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.
Sacituzumab Govitecan combined with ToripalimabCombination product
Sacituzumab Govitecan combined with Toripalimab
Sacituzumab govitecan combined with anti-angiogenesisCombination product
Sacituzumab govitecan combined with anti-angiogenesis( Bevacizumab or Anlotinib Hydrochloride)
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab govitecan combined with Toripalimab | Experimental | Sacituzumab govitecan (Trop-2 ADC) : 10mg/kg on days 1 and 8, intravenous infusion, every 3 weeks for a treatment cycle.
Toripalimab 240 mg was given intravenously on day 1 of each cycle, every 3 weeks for a treatment cycle. Receives: Combination Product: Sacituzumab Govitecan combined with Toripalimab |
| Sacituzumab govitecan combined with anti-angiogenesis | Experimental | Sacituzumab govitecan (Trop-2 ADC) : 10mg/kg on days 1 and 8, intravenous infusion, every 3 weeks for a treatment cycle.
Antiangiogenesis targeted drugs: Bevacizumab or Anlotinib Hydrochloride, according to the standard dose treatment. Receives: Combination Product: Sacituzumab govitecan combined with anti-angiogenesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
Measured: Until progression or death, up to approximately 60 months
Secondary outcomes (2)
Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Measured: Until progression, up to approximately 60 months
Overall Survival (OS)
OS is defined as the time from randomization until the date of death from any cause.
Measured: Until death, up to approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
6 Dec 202430 Jun 2027
- First posted17 Mar 2025
- Study start6 Dec 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 138 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunfang Hao, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878625
- Sponsor's protocol ID
- Y-Gilead2024-PT-0235
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2025
- Last updated
- 25 Mar 2025
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Cohort Study Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06878625
- Acronym / sponsor ID
- Y-Gilead2024-PT-0235
- Conditions
- Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast Cancer
- Keywords
- Sacituzumab govitecan, triple negative breast cancer, PD-1 monoclonal antibody, anti-angiogenesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Mar 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.
Research purposes: the research design in the late more than 2 lines TNBC prospective, multicenter, cohort study, respectively to observe Trop2 - ADC joint PD - 1 single or combined anti-angiogenesis drugs (macromolecular single bevacizumab or small molecules TKI resistance, for, as the default layered) the efficacy and safety. Indications: Trop2 - ADC joint PD - 1 single or combined anti-angiogenesis drugs (macromolecular single bevacizumab or small molecules TKI resistance, for, as the default layered) treat above 2 late three negative breast cancer (TNBC).
Detailed description
- Study Population
- Eligible Participants: Patients with triple - negative metastatic breast cancer at the second line of treatment or higher. Triple - negative invasive breast cancer is histologically confirmed, defined as immunohistochemical detection revealing estrogen receptor (ER) < 10%, progesterone receptor (PR) < 10%, and HER2 0 - 1+ or HER2 2+ with negative fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) results, in accordance with the 2018 ASCO - CAP HER2 - negative identification guidelines.
- Experimental Design
- Study Type: Multicenter, prospective cohort study.
- Sample Size Determination
- The sample size is calculated based on the primary endpoint of progression - free survival (PFS). Drawing on data from ASCENT (a confirmatory phase III study on the efficacy in triple - negative breast cancer) and EVER - 132 - 001 (a Chinese population bridging study presented at the ESMO Congress), the PFS of sacituzumab govitecan monotherapy in metastatic triple - negative breast cancer (mTNBC) is approximately 5.6 months.
- Assuming a hazard ratio of 0.70 in each cohort (median PFS value of 8 months vs. 5.6 months), to detect a statistically significant difference between the trial group and the sacituzumab govitecan monotherapy control group at a one - sided significance level of 0.05 and a power of 80%, 51 PFS events are required. Given an enrollment period of 18 months and a total study duration of 30 months, 69 subjects are needed for each cohort.
- Dosage Regimens
- 4.1 Sacituzumab Govitecan Dose and Administration: The recommended dose is 10 mg/kg. It is administered by intravenous infusion on days 1 and 8 of each treatment cycle, with each cycle lasting three weeks.
- 4.2 Toripalimab Dose and Administration: 240 mg is administered by intravenous infusion on day 1 of each cycle. Each treatment cycle has a duration of three weeks.
- 4.3 Antiangiogenic Targeted Drugs Options and Dosage: Bevacizumab or Anlotinib can be selected. Treatment is carried out according to the standard dosage for each respective drug.
- Inclusion Criteria
- Age between 18 and 70 years.
- Histologically - confirmed triple - negative invasive breast cancer as per the defined immunohistochemical and molecular criteria.
- For patients with locally advanced or metastatic breast cancer: Those who have undergone radical surgery. Those who have received at least one but no more than two lines of chemotherapy in the advanced treatment phase. Additionally, early - stage triple - negative breast cancer patients who experienced disease progression within one year after neoadjuvant or adjuvant therapy are eligible.
- No prior use of immunotherapeutic drugs or anti - angiogenic drugs.
- At least one measurable lesion as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- No contraindications to chemotherapy, immunotherapy, or anti - angiogenic therapy.
- Permitted to have stable or asymptomatic brain metastases.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 - 2, with a predicted survival exceeding 12 weeks.
- All acute toxicities from previous anticancer therapies must have resolved to Grade ≤1 according to the protocol criteria (excluding alopecia) before screening.
- Women of childbearing potential must agree to use medically approved contraception during treatment and for at least three months post - treatment.
- Adequate organ function meeting the following criteria: Hemoglobin ≥ 90 g/L without transfusion within 14 days. Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L. Platelets ≥ 75×10⁹/L. Total Bilirubin ≤ 1.5× the upper limit of normal (ULN). Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3×ULN (≤ 5×ULN if liver metastasis is present). Serum Creatinine ≤ 1×ULN. Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
- Participants must voluntarily enroll in the study, demonstrate excellent adherence, and actively participate in safety and survival follow - up assessments.
- Exclusion Criteria
- Uncontrolled central nervous system metastases (symptomatic or requiring glucocorticoids or mannitol for symptom management).
- Symptomatic third - space effusions, including pericardial, pleural, and peritoneal effusions, that cannot be adequately managed by drainage or other therapeutic interventions.
- Participation in another clinical trial within 30 days prior to enrollment. History of other malignancies within the past 5 years, excluding adequately treated cervical carcinoma in situ, skin squamous cell carcinoma, thyroid carcinoma, or controlled basal cell carcinoma.
- Uncontrolled cardiac conditions, including:
- Heart failure classified as NYHA class II or higher.
- Unstable angina.
- Myocardial infarction within the past year.
- Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- QTc interval greater than 470 ms.
- Arterial or venous thrombotic events within 24 weeks preceding informed consent, such as cerebrovascular accidents (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
- Within 24 weeks prior to signing the informed consent form (ICF), a history of any of the following conditions: peptic ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease, diverticulitis, abdominal fistula, tracheoesophageal fistula, or intra - abdominal abscess. Presence of factors that significantly impair oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- Documented history of allergy with potential hypersensitivity or intolerance to sacituzumab govitecan, toripalimab, bevacizumab, or anlotinib.
- Active human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥ 500 IU/ml), or hepatitis C (hepatitis C antibody positive and detectable HCV RNA).
- Pregnant women, lactating women, fertile women with a positive baseline pregnancy test, or women of childbearing age who are unwilling to use effective contraception for the duration of the trial.
- Presence of concomitant diseases (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders) or any other condition that, in the investigator's judgment, could compromise subject safety, confound study results, or prevent subjects from completing the study.
- Efficacy Endpoints
- 7.1 Primary Endpoint Progression - free survival (PFS).
- 7.2 Secondary Endpoints Objective response rate (ORR). Overall survival (OS). Safety evaluation. Duration of response (DOR). Clinical benefit rate (DCR). Biomarker studies.
- Efficacy is evaluated every two cycles. For treatments showing effectiveness (at least 4 to 6 cycles), immunotherapy or targeted therapy can be continued.
- Safety Indicators
- Adverse events are recorded from the time of completion or signing of the informed consent until the end of the study period as determined by the researchers. All adverse events occurring during this period are to be documented.
- Statistical Methods
- 9.1 General Data Summarization：Unless otherwise specified, data will be summarized using descriptive statistical methods. For measurement data, the mean, standard deviation, median, maximum, and minimum values will be reported. For count data, frequencies and percentages will be used for summarization.
- 9.2 Survival Analysis：The Kaplan - Meier method will be employed to estimate survival rates and plot survival curves for time - to - event data, such as PFS and DOR.
- 9.3 Blood Concentration Data：Blood concentration data will be summarized using the geometric mean, geometric standard deviation, geometric coefficient of variation, mean, standard deviation, coefficient of variation, median, maximum, and minimum values.
- 9.4 Effectiveness Analysis： Effectiveness analysis will be based on the full analysis set (FAS) and the per - protocol set (PPS).The objective response rate (ORR) will be descriptively statistically analyzed according to the stage and dose groups. The number and proportion of subjects with a response (complete response (CR)+partial response (PR)) will be provided, and a two - sided 95% exact confidence interval for the overall ORR will be estimated.PFS and DOR, being time - to - event data, will be analyzed using the Kaplan - Meier method to plot survival curves and estimate the median survival time. When necessary, the two - sided 95% confidence interval for the overall median survival time will be estimated.The clinical benefit rate (DCR) will provide the number and proportion of subjects identified as CR + PR+stable disease (SD), and when necessary, a two - sided 95% exact confidence interval for the DCR will be estimated.
- 9.5 Safety Analysis：Safety analysis will be based on the safety set (actual drug categories). It is limited to summary descriptive statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab govitecan combined with Toripalimab | Experimental | Combination Product: Sacituzumab Govitecan combined with ToripalimabSacituzumab govitecan (Trop-2 ADC) : 10mg/kg on days 1 and 8, intravenous infusion, every 3 weeks for a treatment cycle. Toripalimab 240 mg was given intravenously on day 1 of each cycle, every 3 weeks for a treatment cycle. |
| Sacituzumab govitecan combined with anti-angiogenesis | Experimental | Combination Product: Sacituzumab govitecan combined with anti-angiogenesisSacituzumab govitecan (Trop-2 ADC) : 10mg/kg on days 1 and 8, intravenous infusion, every 3 weeks for a treatment cycle. Antiangiogenesis targeted drugs: Bevacizumab or Anlotinib Hydrochloride, according to the standard dose treatment. |
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)
- Aged between 18 and 70 years.
- Histologically confirmed triple-negative invasive breast cancer, defined as immunohistochemical detection of ER < 10%, PR < 10%, HER2 0-1+ or HER2 2+ with negative FISH or CISH results, in accordance with the 2018 ASCO-CAP HER2-negative identification guidelines.
- Patients with locally advanced or metastatic breast cancer who have undergone radical surgery; patients received at least one but no more than two lines of chemotherapy in the advanced treatment phase. Early-stage triple-negative breast cancer patients who experienced disease progression within one year after neoadjuvant or adjuvant therapy are also eligible.
- No prior use of immunotherapy or anti-angiogenic drugs.
- At least one measurable lesion based on RECIST 1.1 criteria.
Key exclusion criteria (12 listed)
- Uncontrolled central nervous system metastasis (symptomatic or requiring glucocorticoids or mannitol for symptom management);
- Symptomatic third-space effusions, including pericardial, pleural, and peritoneal effusions, that cannot be adequately managed by drainage or other therapeutic interventions;
- Participation in another clinical trial within 30 days prior to enrollment;
- History of other malignancies within the past 5 years, excluding adequately treated cervical carcinoma in situ, skin squamous cell carcinoma, thyroid carcinoma, or controlled basal cell carcinoma;
- Uncontrolled cardiac conditions, such as: (1) heart failure classified as NYHA class II or higher; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc interval greater than 470 ms;
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 |
|---|---|---|
| Sacituzumab Govitecan combined with ToripalimabSacituzumab Govitecan combined with Toripalimab | Combination product | Sacituzumab govitecan combined with Toripalimab |
| Sacituzumab govitecan combined with anti-angiogenesisSacituzumab govitecan combined with anti-angiogenesis( Bevacizumab or Anlotinib Hydrochloride) | Combination product | Sacituzumab govitecan combined with anti-angiogenesis |
Primary outcome
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Until progression or death, up to approximately 60 months
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
2 secondary outcomes
Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1
Time frame: Until progression, up to approximately 60 months
Overall Survival (OS)
Time frame: Until death, up to approximately 60 months
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 25 Mar 2025.
- Individual participant dataSharing planned: Undecided
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 Sacituzumab Govitecan combined with Toripalimab and Sacituzumab govitecan combined with anti-angiogenesis in people with Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 12 inclusion and 12 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 25 Mar 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 Chunfang Hao, Associate chief physician (86-022-60670123 ext. 3805, haochunfang@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (time frame: Until progression or death, up to approximately 60 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 25 Mar 2025.