Triple Negative Breast NeoplasmsPhase 2NCT07788222
Sacituzumab Govitecan and Q901 in Advanced TNBC
A Phase 2 study testing Sacituzumab govitecan and Q901 in people with Triple Negative Breast Neoplasms, run by Yonsei University.
Trial summary
This is a multicenter, open-label, single-arm phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab govitecan (SG) in combination with Q901 in patients with advanced (metastatic/recurrent/unresectable) triple-negative breast cancer (TNBC) whose disease has progressed following prior… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Triple Negative Breast Neoplasms
- What is being tested?
- Sacituzumab govitecan and Q901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed triple-negative breast cancer (TNBC) who have received at least 2 prior lines of systemic anticancer therapy for recurrent, metastatic, or unresectable disease. TNBC is defined as estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative status.
- ER-negative and PR-negative are defined as nuclear staining in <1% of cells by immunohistochemistry (IHC).
- HER2-negative is defined by any of the following:
- IHC 0 or 1+ without in-situ hybridization (ISH) results, or
- IHC 2+ with negative ISH (single-probe ISH average HER2 gene copy number <4 signals/cell, or dual-probe ISH HER2/CEP17 ratio <2.0 with average HER2 gene copy number <4 signals/cell), or
- Negative ISH without IHC results.
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- Male or female patients aged ≥19 years.
- Patients who have received at least 2 prior lines of systemic anticancer therapy for recurrent, metastatic, or unresectable TNBC.
- Prior therapy may include chemotherapy, immunotherapy, or targeted therapy. There is no restriction on the type or sequence of prior therapies (however, prior treatment with a taxane-based regimen is required).
- Patients who received adjuvant/neoadjuvant therapy for surgically resectable breast cancer and relapsed within 12 months after completion of the last chemotherapy are considered to have received 1 line of chemotherapy.
- Patients who have provided written informed consent prior to any study-specific procedures.
- Patients with at least 1 measurable lesion per RECIST 1.1 on baseline CT.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients with adequate organ function as defined below. Transfusion or growth factor support is not permitted within 14 days prior to screening laboratory tests.
- Absolute Neutrophil Count (ANC) ≥ 1,500 cells/mm³ B. Platelets ≥ 100,000/mm³ C. Hemoglobin ≥ 9.0 g/dL D. Total bilirubin ≤ 1.5 × ULN E. AST (SGOT) ≤ 2.5 × ULN (≤ 5.0 × ULN if liver metastases are present) F. ALT (SGPT) ≤ 2.5 × ULN (≤ 5.0 × ULN if liver metastases are present) G. Creatinine clearance ≥ 60 mL/min calculated using the Cockcroft-Gault equation, or serum creatinine ≤ 1.5 × ULN
- 12-lead ECG showing normal findings or non-clinically significant changes not requiring medical intervention.
- QTc interval ≤ 470 msec and no history of Torsades de pointes.
- Women of childbearing potential who are not pregnant or breastfeeding must use an effective method of contraception from 2 weeks before the start of study treatment, during treatment, and until 7 months after completion of study treatment.
- Women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test must be performed.
- Women of childbearing potential must agree to use an adequate method of contraception (as described in Section 11.13), be surgically sterile, or abstain from heterosexual intercourse during the study and until 7 months after the last dose of study drug.
- Women considered to be of non-childbearing potential are defined as follows; patients not meeting these criteria are considered to be of childbearing potential:
- Women who have undergone surgical sterilization (bilateral salpingectomy, bilateral oophorectomy, or hysterectomy)
- Women aged ≥55 years with no spontaneous menstruation for ≥12 months prior to randomization
- Women aged <55 years with no spontaneous menstruation for ≥12 months prior to randomization and a postmenopausal follicle-stimulating hormone (FSH) level >30 IU/L (or meeting the local laboratory's criteria for postmenopausal status)
- Subjects infected with human immunodeficiency virus (HIV) must be receiving anti-retroviral therapy (ART) and have well-controlled HIV infection/disease, defined as follows:
- Subjects on ART must have a CD4+ T-cell count >350 cells/mm³ at screening. Subjects on ART must have achieved and maintained virologic suppression, defined as HIV RNA <50 copies/mL or below the limit of quantification (below the limit of detection) using a locally available assay, at screening and for at least 12 weeks prior to screening.
- Subjects on ART must have been on a stable regimen without any change in drugs or dose adjustment for at least 4 weeks prior to study enrollment (Day 1).
- Concomitant ART must not include any antiretroviral agents other than abacavir, dolutegravir, emtricitabine, lamivudine, raltegravir, rilpivirine, or tenofovir.
- Patients without severe or uncontrolled disease that could interfere with study participation.
- Adequate washout periods prior to enrollment are as follows:
- Treatment Washout Period Major surgery ≥ 4 weeks Radiation therapy ≥ 4 weeks (≥ 2 weeks for stereotactic radiotherapy for palliative purposes)
Who cannot join
- Prior treatment with a TROP2-targeted antibody-drug conjugate, or a history of receiving a selective CDK7 inhibitor including Q901.
- Severe cardiac disease (e.g., uncontrolled hypertension, congestive heart failure [NYHA class ≥2], ventricular arrhythmia, active ischemic heart disease, or history of myocardial infarction within the past 1 year).
- Current active hepatic or biliary disease (Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease may be excluded from this criterion at the investigator's discretion).
- Patients with a clinically significant, uncontrolled medical condition that limits the ability to comply with study procedures, or other medical conditions that place the patient at an unacceptable risk of toxicity.
- Patients with symptomatic CNS metastases, or CNS metastases requiring local treatment (e.g., radiotherapy or surgery). Patients previously treated for brain metastases must be clinically and radiologically stable (no evidence of disease progression and all neurological symptoms returned to baseline from ≥4 weeks after treatment until study enrollment; no evidence of new or progressive brain metastases) and must not have received steroid therapy exceeding physiological doses (>10 mg prednisolone/day) for at least 2 weeks prior to administration of the study drug. Regardless of the above conditions, subjects with leptomeningeal carcinomatosis are not permitted.
- Concomitant use of known strong CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin, and nelfinavir.
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- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients who have completed curative therapy for HCV are eligible. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable at the time of enrollment.
- Patients with significantly impaired mental status, or psychological, familial, sociological, or geographical conditions that impede understanding of the study or potentially interfere with compliance with the study protocol and follow-up schedule.
- Patients diagnosed with another malignancy within 5 years. Exceptions are non-melanoma skin cancer treated with curative intent, in-situ disease treated with curative intent, thyroid cancer, or cervical intraepithelial carcinoma.
- Patients who are pregnant or breastfeeding, or who plan to conceive during the scheduled study period from the screening visit until 7 months after the last dose of study drug.
- Patients who received a live or live-attenuated vaccine within 30 days prior to the scheduled first dose of the study drug.
- Unresolved active systemic infection.
- In addition to the above criteria, the investigator may exclude a subject from the study if the subject is judged to have conditions that may compromise subject safety or the scientific validity of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multi-center, Open-label, Single-arm Phase II Clinical Trial of Sacituzumab-Govitecan Plus Q901 in Advanced TNBC
This is a multicenter, open-label, single-arm phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab govitecan (SG) in combination with Q901 in patients with advanced (metastatic/recurrent/unresectable) triple-negative breast cancer (TNBC) whose disease has progressed following prior therapy, in the third-line treatment setting.
Subjects enrolled in this trial must be patients diagnosed with advanced TNBC who have received at least 2 prior lines of systemic anticancer therapy, which may include chemotherapy, targeted therapy, or immunotherapy. However, for subjects who received adjuvant/neoadjuvant chemotherapy for resectable-stage breast cancer and relapsed within 12 months after completion of the last chemotherapy, the adjuvant/neoadjuvant chemotherapy is counted as one line of therapy. There are no restrictions on the type or sequence of prior therapies, but all subjects must have measurable disease per RECIST 1.1 criteria at the time of enrollment.
Read more
Subjects will be assigned to a single treatment arm and will receive the following combination regimen:
Sacituzumab govitecan (SG): 10 mg/kg administered intravenously on Day 1 and Day 8 of each 21-day cycle Q901: 126 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle
Each treatment cycle is defined as 21 days, and study drug administration will continue until disease progression, unacceptable toxicity, discontinuation of treatment at the discretion of the investigator or subject, withdrawal of consent, or death.
Prior to full-scale phase II enrollment, this trial includes a safety run-in phase to evaluate the initial safety and dose appropriateness of the SG plus Q901 combination.
In the safety run-in phase, a small number of subjects will receive the combination regimen to assess the occurrence of dose-limiting toxicities (DLTs); if DLTs are observed, dose de-escalation of Q901 will be considered.
Based on the results of the safety run-in, the final combination dose to be used in the phase II portion will be determined, after which expansion enrollment will proceed.
The target number of subjects to be enrolled in this trial is a maximum of 6-18 in the safety run-in phase and 30 in the phase II portion, for a total maximum enrollment of 48 subjects across the entire trial.
The primary endpoint is objective response rate per RECIST v1.1; secondary endpoints include progression-free survival, overall survival, duration of response, disease control rate, safety, and quality of life.
Read the detailed description
- Study design: A multicenter, open-label, single-arm Phase II study conducted at six institutions in Korea. This is a multicenter, open-label, single-arm phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab govitecan (SG) in combination with Q901 in patients with advanced (metastatic/recurrent/unresectable) triple-negative breast cancer (TNBC) whose disease has progressed following prior therapy, in the third-line treatment setting. Subjects enrolled in this trial must be patients diagnosed with advanced TNBC who have received at least 2 prior lines of systemic anticancer therapy, which may include chemotherapy, targeted therapy, or immunotherapy. However, for subjects who received adjuvant/neoadjuvant chemotherapy for resectable-stage breast cancer and relapsed within 12 months after completion of the last chemotherapy, the adjuvant/neoadjuvant chemotherapy is counted as one line of therapy. There are no restrictions on the type or sequence of prior therapies, but all subjects must have measurable disease per RECIST 1.1 criteria at the time of enrollment.
- Study Treatment Arm Subjects will be assigned to a single treatment arm and will receive the following combination regimen:
- Sacituzumab govitecan (SG): 10 mg/kg administered intravenously on Day 1 and Day 8 of each 21-day cycle
- Q901: 126 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle Each treatment cycle is defined as 21 days, and study drug administration will continue until disease progression, unacceptable toxicity, discontinuation of treatment at the discretion of the investigator or subject, withdrawal of consent, or death.
- Safety Run-in Phase Prior to full-scale phase II enrollment, this trial includes a safety run-in phase to evaluate the initial safety and dose appropriateness of the SG plus Q901 combination. In the safety run-in phase, a small number of subjects will receive the combination regimen to assess the occurrence of dose-limiting toxicities (DLTs); if DLTs are observed, dose de-escalation of Q901 will be considered. Based on the results of the safety run-in, the final combination dose to be used in the phase II portion will be determined, after which expansion enrollment will proceed. The key items to be assessed during the safety run-in phase are as follows: Occurrence and characteristics of DLTs Frequency and severity of treatment-related adverse events Initial tolerability of the SG plus Q901 combination regimen
- Principles for Management of Adverse Events If adverse events occur during administration of the combination regimen in this trial, Sacituzumab govitecan (SG) will be dose-reduced, delayed, or discontinued in accordance with the prescribing information and standard clinical guidelines, while Q901 will follow the dose modification and reduction principles established in its phase I clinical trial. When adverse events occur, independent dose reduction or schedule adjustment for the relevant study drug may be applied based on the assessed relationship (attribution) of the event to each drug.
- Target Number of Subjects and Primary Endpoint
The target enrollment for this trial is a total of 36-48 subjects (6-18 in safety run-in + 30 in phase II), which has been set taking the dropout rate into consideration.
This trial is designed as a single-arm study, with the Objective Response Rate (ORR) of the combination regimen set as the primary efficacy endpoint.
Tumor response will be assessed according to RECIST version 1.1 criteria, with computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen, and pelvis performed at baseline prior to enrollment and repeated every 8 weeks thereafter until disease progression.
Safety will be assessed continuously throughout the study drug administration period, with a defined safety follow-up period conducted after the last dose of study drug.
- Conditions
- Triple Negative Breast Neoplasms
- Being tested
- Sacituzumab govitecan and Q901
- Keywords
- Triple-Negative Breast Cancer (TNBC), Sacituzumab Govitecan (SG), Q901, CDK7 inhibitor, Antibody-Drug Conjugate (ADC)
- 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 and Q901Drug
Also called Sacituzumab govitecan: Trodelvy (SG). Q901: selective CDK7 inhibitor.
Sacituzumab govitecan 10 mg/kg is administered intravenously on Days 1 and 8 of every 21-day cycle. Q901 126 mg/m² is administered intravenously over 60 minutes on Days 1 and 8 of every 21-day cycle. Both agents are given in combination until disease progression, unacceptable toxicity, withdrawal of consent, or death.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Govitecan plus Q901 | Experimental | Participants receive sacituzumab govitecan 10 mg/kg (intravenous) and Q901 126 mg/m² (intravenous, over 60 minutes) on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death. Receives: Drug: Sacituzumab govitecan and Q901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate, ORR by RECIST v1.1
Objective response rate (ORR) is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) as best overall response per RECIST v1.1. Tumor response is assessed by CT or MRI every 8 weeks, and responses are confirmed by imaging performed at least 4 weeks apart
Measured: Up to 24 months
Secondary outcomes (8)
Progression-Free Survival (PFS)
Time from the first dose (Cycle 1 Day 1) to the first occurrence of disease progression per RECIST v1.1 or death from any cause, whichever comes first.
Measured: Up to 24 months
overall survival (OS)
Time from the first dose to death from any cause.
Measured: Up to 24 months
Duration of Response (DoR)
Time from the first documented objective response (CR or PR) to disease progression per RECIST v1.1 or death, whichever comes first; evaluated only in participants with a confirmed objective response.
Measured: Up to 24 months
Disease Control Rate (DCR)
Proportion of participants achieving complete response, partial response, or stable disease as best overall response per RECIST v1.1.
Measured: Up to 24 months
Adverse Events (AE)
Incidence, type, and severity of adverse events graded according to CTCAE version 5.0
Measured: Up to 24 months
Quality of life (QoL) by EORTC QLQ-C30 questionnaire
Change in health-related quality of life assessed using the EORTC QLQ-C30)
Measured: up to 24 months
Quality of life (QoL) by QLQ-BR23 questionnaire
Change in health-related quality of life assessed using the QLQ-BR23 questionnaire
Measured: up to 24 months
Exploratory Biomarker Analysis
Exploration of predictive biomarkers for combination therapy response using blood sample and tumor tissue samples
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Jun 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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm study in which all participants receive the same combination regimen (sacituzumab govitecan plus Q901). A safety run-in phase precedes Phase II enrollment.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788222
- Sponsor's protocol ID
- 4-2026-0705
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open-label, Single-arm Phase II Clinical Trial of Sacituzumab-Govitecan Plus Q901 in Advanced TNBC
- ClinicalTrials.gov ID
- NCT07788222
- Acronym / sponsor ID
- 4-2026-0705
- Conditions
- Triple Negative Breast Neoplasms
- Keywords
- Triple-Negative Breast Cancer (TNBC), Sacituzumab Govitecan (SG), Q901, CDK7 inhibitor, Antibody-Drug Conjugate (ADC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Aug 2026 (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 multicenter, open-label, single-arm phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab govitecan (SG) in combination with Q901 in patients with advanced (metastatic/recurrent/unresectable) triple-negative breast cancer (TNBC) whose disease has progressed following prior therapy, in the third-line treatment setting.
Subjects enrolled in this trial must be patients diagnosed with advanced TNBC who have received at least 2 prior lines of systemic anticancer therapy, which may include chemotherapy, targeted therapy, or immunotherapy. However, for subjects who received adjuvant/neoadjuvant chemotherapy for resectable-stage breast cancer and relapsed within 12 months after completion of the last chemotherapy, the adjuvant/neoadjuvant chemotherapy is counted as one line of therapy. There are no restrictions on the type or sequence of prior therapies, but all subjects must have measurable disease per RECIST 1.1 criteria at the time of enrollment.
Subjects will be assigned to a single treatment arm and will receive the following combination regimen:
Sacituzumab govitecan (SG): 10 mg/kg administered intravenously on Day 1 and Day 8 of each 21-day cycle Q901: 126 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle
Each treatment cycle is defined as 21 days, and study drug administration will continue until disease progression, unacceptable toxicity, discontinuation of treatment at the discretion of the investigator or subject, withdrawal of consent, or death.
Prior to full-scale phase II enrollment, this trial includes a safety run-in phase to evaluate the initial safety and dose appropriateness of the SG plus Q901 combination.
In the safety run-in phase, a small number of subjects will receive the combination regimen to assess the occurrence of dose-limiting toxicities (DLTs); if DLTs are observed, dose de-escalation of Q901 will be considered.
Based on the results of the safety run-in, the final combination dose to be used in the phase II portion will be determined, after which expansion enrollment will proceed.
The target number of subjects to be enrolled in this trial is a maximum of 6-18 in the safety run-in phase and 30 in the phase II portion, for a total maximum enrollment of 48 subjects across the entire trial.
The primary endpoint is objective response rate per RECIST v1.1; secondary endpoints include progression-free survival, overall survival, duration of response, disease control rate, safety, and quality of life.
Detailed description
- Study design: A multicenter, open-label, single-arm Phase II study conducted at six institutions in Korea. This is a multicenter, open-label, single-arm phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab govitecan (SG) in combination with Q901 in patients with advanced (metastatic/recurrent/unresectable) triple-negative breast cancer (TNBC) whose disease has progressed following prior therapy, in the third-line treatment setting. Subjects enrolled in this trial must be patients diagnosed with advanced TNBC who have received at least 2 prior lines of systemic anticancer therapy, which may include chemotherapy, targeted therapy, or immunotherapy. However, for subjects who received adjuvant/neoadjuvant chemotherapy for resectable-stage breast cancer and relapsed within 12 months after completion of the last chemotherapy, the adjuvant/neoadjuvant chemotherapy is counted as one line of therapy. There are no restrictions on the type or sequence of prior therapies, but all subjects must have measurable disease per RECIST 1.1 criteria at the time of enrollment.
- Study Treatment Arm Subjects will be assigned to a single treatment arm and will receive the following combination regimen:
- Sacituzumab govitecan (SG): 10 mg/kg administered intravenously on Day 1 and Day 8 of each 21-day cycle
- Q901: 126 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle Each treatment cycle is defined as 21 days, and study drug administration will continue until disease progression, unacceptable toxicity, discontinuation of treatment at the discretion of the investigator or subject, withdrawal of consent, or death.
- Safety Run-in Phase Prior to full-scale phase II enrollment, this trial includes a safety run-in phase to evaluate the initial safety and dose appropriateness of the SG plus Q901 combination. In the safety run-in phase, a small number of subjects will receive the combination regimen to assess the occurrence of dose-limiting toxicities (DLTs); if DLTs are observed, dose de-escalation of Q901 will be considered. Based on the results of the safety run-in, the final combination dose to be used in the phase II portion will be determined, after which expansion enrollment will proceed. The key items to be assessed during the safety run-in phase are as follows: Occurrence and characteristics of DLTs Frequency and severity of treatment-related adverse events Initial tolerability of the SG plus Q901 combination regimen
- Principles for Management of Adverse Events If adverse events occur during administration of the combination regimen in this trial, Sacituzumab govitecan (SG) will be dose-reduced, delayed, or discontinued in accordance with the prescribing information and standard clinical guidelines, while Q901 will follow the dose modification and reduction principles established in its phase I clinical trial. When adverse events occur, independent dose reduction or schedule adjustment for the relevant study drug may be applied based on the assessed relationship (attribution) of the event to each drug.
- Target Number of Subjects and Primary Endpoint
The target enrollment for this trial is a total of 36-48 subjects (6-18 in safety run-in + 30 in phase II), which has been set taking the dropout rate into consideration.
This trial is designed as a single-arm study, with the Objective Response Rate (ORR) of the combination regimen set as the primary efficacy endpoint.
Tumor response will be assessed according to RECIST version 1.1 criteria, with computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen, and pelvis performed at baseline prior to enrollment and repeated every 8 weeks thereafter until disease progression.
Safety will be assessed continuously throughout the study drug administration period, with a defined safety follow-up period conducted after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm study in which all participants receive the same combination regimen (sacituzumab govitecan plus Q901). A safety run-in phase precedes Phase II enrollment.
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan plus Q901 | Experimental | Drug: Sacituzumab govitecan and Q901Participants receive sacituzumab govitecan 10 mg/kg (intravenous) and Q901 126 mg/m² (intravenous, over 60 minutes) on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Patients with histologically or cytologically confirmed triple-negative breast cancer (TNBC) who have received at least 2 prior lines of systemic anticancer therapy for recurrent, metastatic, or unresectable disease. TNBC is defined as estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative status.
- ER-negative and PR-negative are defined as nuclear staining in <1% of cells by immunohistochemistry (IHC).
- Male or female patients aged ≥19 years.
- Patients who have received at least 2 prior lines of systemic anticancer therapy for recurrent, metastatic, or unresectable TNBC.
- Prior therapy may include chemotherapy, immunotherapy, or targeted therapy. There is no restriction on the type or sequence of prior therapies (however, prior treatment with a taxane-based regimen is required).
Key exclusion criteria (13 listed)
- Prior treatment with a TROP2-targeted antibody-drug conjugate, or a history of receiving a selective CDK7 inhibitor including Q901.
- Severe cardiac disease (e.g., uncontrolled hypertension, congestive heart failure [NYHA class ≥2], ventricular arrhythmia, active ischemic heart disease, or history of myocardial infarction within the past 1 year).
- Current active hepatic or biliary disease (Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease may be excluded from this criterion at the investigator's discretion).
- Patients with a clinically significant, uncontrolled medical condition that limits the ability to comply with study procedures, or other medical conditions that place the patient at an unacceptable risk of toxicity.
- Patients with symptomatic CNS metastases, or CNS metastases requiring local treatment (e.g., radiotherapy or surgery). Patients previously treated for brain metastases must be clinically and radiologically stable (no evidence of disease progression and all neurological symptoms returned to baseline from ≥4 weeks after treatment until study enrollment; no evidence of new or progressive brain metastases) and must not have received steroid therapy exceeding physiological doses (>10 mg prednisolone/day) for at least 2 weeks prior to administration of the study drug. Regardless of the above conditions, subjects with leptomeningeal carcinomatosis are not permitted.
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 and Q901Also: Sacituzumab govitecan: Trodelvy (SG). Q901: selective CDK7 inhibitor.Sacituzumab govitecan 10 mg/kg is administered intravenously on Days 1 and 8 of every 21-day cycle. Q901 126 mg/m² is administered intravenously over 60 minutes on Days 1 and 8 of every 21-day cycle. Both agents are given in combination until disease progression, unacceptable toxicity, withdrawal of consent, or death. | Drug | Sacituzumab Govitecan plus Q901 |
Primary outcome
Objective Response Rate, ORR by RECIST v1.1
Time frame: Up to 24 months
Objective response rate (ORR) is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) as best overall response per RECIST v1.1. Tumor response is assessed by CT or MRI every 8 weeks, and responses are confirmed by imaging performed at least 4 weeks apart
8 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 24 months
overall survival (OS)
Time frame: Up to 24 months
Duration of Response (DoR)
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Adverse Events (AE)
Time frame: Up to 24 months
Quality of life (QoL) by EORTC QLQ-C30 questionnaire
Time frame: up to 24 months
Quality of life (QoL) by QLQ-BR23 questionnaire
Time frame: up to 24 months
Exploratory Biomarker Analysis
Time frame: up to 24 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 26 Aug 2026.
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Breast Cancer, Breast Carcinoma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab govitecan and Q901 in people with Triple Negative Breast Neoplasms, run by Yonsei 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 31 inclusion and 13 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: opening soon, as of the sponsor's last update on 26 Aug 2026. 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 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 Joohyuk Sohn, Professor (82-2-228-8135, oncosohn@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate, ORR by RECIST v1.1 (time frame: Up to 24 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 26 Aug 2026.