Early Breast CancerPhase 2QUEEN-NeoNCT06404463
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer
A Phase 2 study testing QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Albumin-bound paclitaxel and Doxorubicin in people with Early Breast Cancer and Neoadjuvant Therapy, run by Fudan University.
Trial summary
This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel followed by AC/EC in a neoadjuvant setting, in high-risk, ER+/HER2- early breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Early Breast Cancer, Neoadjuvant Therapy, HR+HER2- Breast Cancer
- What is being tested?
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Albumin-bound paclitaxel and Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2024to 6 Nov 2030
- 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
- Voluntarily join this study and sign the informed consent form;
- Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO/CAP guidelines, histopathologically confirmed ER+/HER2- breast cancer, histological grade II, Ki-67 ≥ 20% and TNM stage T1c-T2, cN1-cN2 or T3- T4, cN0-cN2;
- According to RECIST 1.1, there is at least one measurable lesion;
- ECOG score: 0~1;
- Tumor tissue specimens that can be used for biomarker detection;
- The function of vital organs meets the following requirements (no blood components or cell growth factor drugs are allowed within 14 days before the first medication):
- Absolute neutrophil count ≥1.5×109/L; (2) Platelets ≥100×109/L; (3) Hemoglobin ≥90 g/L; (4) Serum albumin ≥30 g/L; (5) Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, the FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are normal, you can be included in the group); (6) Serum total bilirubin ≤1.5×ULN; (7) ALT and AST ≤2.5×ULN, if liver metastasis is present, ALT and AST ≤5ULN; (8) AKP≤2.5×ULN; Serum creatinine ≤1.5×ULN; (9) International normalized ratio (INR) ≤1.5 (not receiving anticoagulant therapy).
Who cannot join
- The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included);
- Are currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose >10 mg/day prednisone or other effective hormones), and are still using it within 2 weeks before enrollment;
- Severe allergic reactions to other monoclonal antibodies;
- Known history or evidence of interstitial lung disease or active non-infectious pneumonia;
- Those with known central nervous system metastasis;
- Suffered from other malignant tumors in the past 5 years or at the same time (except cured basal cell carcinoma of the skin and cervical cancer in situ);
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- Suffering from high blood pressure that cannot be well controlled by antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); the above parameters are allowed to be achieved through the use of antihypertensive treatment; there has been a hypertensive crisis or high blood pressure in the past Hypertensive encephalopathy;
- Have cardiac clinical symptoms or diseases that cannot be well controlled, such as (1) NYHA grade 2 or above heart failure (2) Unstable angina (3) Myocardial infarction within 1 year (4) Clinically significant supraventricular infarction or ventricular arrhythmia requiring treatment or intervention (5) QTc>450ms (male); QTc>470ms (female);
- Those who are receiving thrombolysis or anticoagulation therapy are allowed to use low-dose aspirin and low-molecular-weight heparin prophylactically;
- Have clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment; if fecal occult blood is positive during the baseline period, it can be re-examined. If it is still positive after the reexamination, a gastroscopy is required;
- The tumor invades important blood vessels, or the researcher determines based on imaging that there is a high possibility that the cancer will invade important blood vessels in the future study period, which may lead to fatal bleeding;
- Patients with pleural effusion, ascites or pericardial effusion that require drainage can be enrolled if the researcher assesses that the symptoms are stable after drainage;
- Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia patients, coagulation disorders, etc.);
- Major vascular disease (for example, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the start of study treatment;
- Urine routine shows urine protein ≥ ++ and confirmed 24-hour urine protein amount >1.0 g;
- Suffering from active infection, unexplained fever ≥38.5℃ within 7 days before taking the drug, or baseline white blood cell count >15×109/L;
- Those with congenital or acquired immune deficiency (such as HIV infection); those who are hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU/ml, or hepatitis C virus antibody positive;
- Have received live vaccines less than 4 weeks before study medication or may be vaccinated during the study period;
- In the judgment of the researcher, the patient has other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests. Abnormalities, accompanied by family or social factors, may affect the patient's safety.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Li Chen, MD contact
About this study
Official title: A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk ER+/HER2- Early-Stage Breast Cancer (QUEEN-Neo)
This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel followed by AC/EC in a neoadjuvant setting, in high-risk, ER+/HER2- early breast cancer.
Read the detailed description
This study is a single-arm, single-center, phase II clinical trial aimed at observing and evaluating the effectiveness and safety of QL1706 combined with albumin-bound paclitaxel, sequential AC (doxorubicin/cyclophosphamide) neoadjuvant therapy for early high-risk ER+/HER2- breast cancer.
A total of 76 subjects are planned to be enrolled. After enrollment, subjects will receive QL1706 combined with albumin-bound paclitaxel for 4 cycles followed by sequential AC/EC treatment for 4 cycles. Each treatment cycle will span 3 weeks until the occurrence of a specified treatment termination event, after which subjects will continue to undergo postoperative efficacy and safety assessments.
Safety assessments will be conducted before each QL1706 treatment cycle. Imaging evaluations will be performed every 2 cycles until completion of 8 cycles of treatment to assess efficacy. Additional imaging assessments may be performed as clinically indicated during the study. Tumor imaging assessments will continue until confirmed disease progression according to RECIST v1.1 criteria, initiation of new anti-tumor therapy, withdrawal of consent, or death, whichever occurs first.
Following treatment completion, a treatment completion visit will be conducted. Subjects who discontinue treatment due to reasons other than RECIST v1.1-defined disease progression will undergo regular tumor imaging assessment follow-ups to evaluate time to disease progression. Subjects will also undergo survival follow-up visits every 6 months (every 3 months in the first year and every 6 months thereafter) after treatment completion to collect and record survival status and subsequent anti-tumor treatment information.
- Being tested
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Albumin-bound paclitaxel, Doxorubicin, Cyclophosphamide, Epirubicin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706 (bispecific antibody targeting PD-1 and CLTA-4)Drug
QL1706 is a novel bispecific combination antibody composed of a recombinant humanized IgG4 monoclonal antibody targeting human PD-1 (programmed cell death protein 1) (PSB103) and a recombinant humanized IgG1 monoclonal antibody targeting human CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) (PSB105). Both antibodies have undergone engineering modifications to introduce mutations facilitating their correct assembly and preventing mispairing, and are expressed in the same cell line at a predetermined ratio (approximately 2:1).
Albumin-bound paclitaxelDrug
Albumin-bound paclitaxel improves the solubility and delivery of paclitaxel to tumor cells by binding to human albumin, facilitating its transportation through the bloodstream and enhancing its uptake into tumor tissue. It works by binding to and stabilizing microtubules within cancer cells, thereby disrupting the normal process of cell division and leading to cell cycle arrest and apoptosis, ultimately resulting in the death of cancer cells.
DoxorubicinDrug
Doxorubicin, a widely used chemotherapy drug, belongs to the anthracycline class and is effective against various cancers, including breast cancer, leukemia, and sarcomas. It works by intercalating with DNA and inhibiting topoisomerase II, leading to DNA damage and disruption of DNA replication and transcription processes within cancer cells. Despite its efficacy, doxorubicin may cause side effects such as cardiotoxicity and bone marrow suppression, limiting its long-term use in some patients.
CyclophosphamideDrug
Cyclophosphamide is a chemotherapy medication commonly used to treat various types of cancers, including lymphoma, leukemia, and breast cancer. It belongs to the class of alkylating agents and works by crosslinking DNA strands, which prevents cell division and leads to cell death. While effective in treating cancer, cyclophosphamide can also cause side effects such as nausea, vomiting, and suppression of the immune system.
EpirubicinDrug
Epirubicin, a chemotherapy medication, is part of the anthracycline class and is used in the treatment of various cancers, including breast cancer, ovarian cancer, and soft tissue sarcoma. It functions by interfering with DNA replication and RNA synthesis within cancer cells, ultimately leading to cell death. Despite its efficacy, epirubicin can cause side effects such as nausea, hair loss, and bone marrow suppression.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 | Experimental | QL1706 (bispecific antibody (bsAb) targeting PD-1 and CLTA-4)+nab-P-AC/EC Receives: Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4); Drug: Albumin-bound paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pathological complete response (tpCR) rate using the definition of ypT0/Tis ypN0
No invasive residual in breast or nodes; noninvasive breast residuals allowed ) at the time of definitive surgery
Measured: Up to approximately 36 weeks after study start
Secondary outcomes (4)
pCR rate using an alternative definition, ypT0/Tis
PCR rate (ypT0/Tis) is defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery.
Measured: Up to approximately 36 weeks after study start
pCR rate in PD-L1+ population
pCR rate (ypT0/is ypN0) is defined as the percentage of participants without residual invasive on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in participants with tumors expressing Programmed Death-Ligand 1 (PD-L1).
Measured: Up to approximately 36 weeks after study start
rate of RCB scored 0-1
Residual cancer burden scored at 0-1 on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy assessed by the local pathologist at the time of definitive surgery.
Measured: Up to approximately 36 weeks after study start
Objective Response Rate (ORR) Objective Response Rate (ORR) Objective Response Rate (ORR) Objective Response Rate (ORR)Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
Measured: Up to approximately 36 weeks after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start6 May 2024 (estimated)
- Primary completion6 Nov 2025 (estimated)
- Study completion6 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, MD,PhD, Principal investigator, Breast cancer institute of Fudan University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404463
- Sponsor's protocol ID
- SCHBCC-N070
- Acronym
- QUEEN-Neo
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk ER+/HER2- Early-Stage Breast Cancer (QUEEN-Neo)
- ClinicalTrials.gov ID
- NCT06404463
- Acronym / sponsor ID
- QUEEN-Neo / SCHBCC-N070
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 6 Nov 2025 (estimated)
- Study completion
- 6 Nov 2030 (estimated)
- First posted
- 8 May 2024 (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 study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel followed by AC/EC in a neoadjuvant setting, in high-risk, ER+/HER2- early breast cancer.
Detailed description
This study is a single-arm, single-center, phase II clinical trial aimed at observing and evaluating the effectiveness and safety of QL1706 combined with albumin-bound paclitaxel, sequential AC (doxorubicin/cyclophosphamide) neoadjuvant therapy for early high-risk ER+/HER2- breast cancer.
A total of 76 subjects are planned to be enrolled. After enrollment, subjects will receive QL1706 combined with albumin-bound paclitaxel for 4 cycles followed by sequential AC/EC treatment for 4 cycles. Each treatment cycle will span 3 weeks until the occurrence of a specified treatment termination event, after which subjects will continue to undergo postoperative efficacy and safety assessments.
Safety assessments will be conducted before each QL1706 treatment cycle. Imaging evaluations will be performed every 2 cycles until completion of 8 cycles of treatment to assess efficacy. Additional imaging assessments may be performed as clinically indicated during the study. Tumor imaging assessments will continue until confirmed disease progression according to RECIST v1.1 criteria, initiation of new anti-tumor therapy, withdrawal of consent, or death, whichever occurs first.
Following treatment completion, a treatment completion visit will be conducted. Subjects who discontinue treatment due to reasons other than RECIST v1.1-defined disease progression will undergo regular tumor imaging assessment follow-ups to evaluate time to disease progression. Subjects will also undergo survival follow-up visits every 6 months (every 3 months in the first year and every 6 months thereafter) after treatment completion to collect and record survival status and subsequent anti-tumor treatment information.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 | Experimental | Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Drug: Albumin-bound paclitaxel, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: EpirubicinQL1706 (bispecific antibody (bsAb) targeting PD-1 and CLTA-4)+nab-P-AC/EC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily join this study and sign the informed consent form;
- Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO/CAP guidelines, histopathologically confirmed ER+/HER2- breast cancer, histological grade II, Ki-67 ≥ 20% and TNM stage T1c-T2, cN1-cN2 or T3- T4, cN0-cN2;
- According to RECIST 1.1, there is at least one measurable lesion;
- ECOG score: 0~1;
- Tumor tissue specimens that can be used for biomarker detection;
Key exclusion criteria (20 listed)
- The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included);
- Are currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose >10 mg/day prednisone or other effective hormones), and are still using it within 2 weeks before enrollment;
- Severe allergic reactions to other monoclonal antibodies;
- Known history or evidence of interstitial lung disease or active non-infectious pneumonia;
- Those with known central nervous system metastasis;
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 |
|---|---|---|
| QL1706 (bispecific antibody targeting PD-1 and CLTA-4)QL1706 is a novel bispecific combination antibody composed of a recombinant humanized IgG4 monoclonal antibody targeting human PD-1 (programmed cell death protein 1) (PSB103) and a recombinant humanized IgG1 monoclonal antibody targeting human CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) (PSB105). Both antibodies have undergone engineering modifications to introduce mutations facilitating their correct assembly and preventing mispairing, and are expressed in the same cell line at a predetermined ratio (approximately 2:1). | Drug | QL1706 |
| Albumin-bound paclitaxelAlbumin-bound paclitaxel improves the solubility and delivery of paclitaxel to tumor cells by binding to human albumin, facilitating its transportation through the bloodstream and enhancing its uptake into tumor tissue. It works by binding to and stabilizing microtubules within cancer cells, thereby disrupting the normal process of cell division and leading to cell cycle arrest and apoptosis, ultimately resulting in the death of cancer cells. | Drug | QL1706 |
| DoxorubicinDoxorubicin, a widely used chemotherapy drug, belongs to the anthracycline class and is effective against various cancers, including breast cancer, leukemia, and sarcomas. It works by intercalating with DNA and inhibiting topoisomerase II, leading to DNA damage and disruption of DNA replication and transcription processes within cancer cells. Despite its efficacy, doxorubicin may cause side effects such as cardiotoxicity and bone marrow suppression, limiting its long-term use in some patients. | Drug | QL1706 |
| CyclophosphamideCyclophosphamide is a chemotherapy medication commonly used to treat various types of cancers, including lymphoma, leukemia, and breast cancer. It belongs to the class of alkylating agents and works by crosslinking DNA strands, which prevents cell division and leads to cell death. While effective in treating cancer, cyclophosphamide can also cause side effects such as nausea, vomiting, and suppression of the immune system. | Drug | QL1706 |
| EpirubicinEpirubicin, a chemotherapy medication, is part of the anthracycline class and is used in the treatment of various cancers, including breast cancer, ovarian cancer, and soft tissue sarcoma. It functions by interfering with DNA replication and RNA synthesis within cancer cells, ultimately leading to cell death. Despite its efficacy, epirubicin can cause side effects such as nausea, hair loss, and bone marrow suppression. | Drug | QL1706 |
Primary outcome
Total Pathological complete response (tpCR) rate using the definition of ypT0/Tis ypN0
Time frame: Up to approximately 36 weeks after study start
No invasive residual in breast or nodes; noninvasive breast residuals allowed ) at the time of definitive surgery
4 secondary outcomes
pCR rate using an alternative definition, ypT0/Tis
Time frame: Up to approximately 36 weeks after study start
pCR rate in PD-L1+ population
Time frame: Up to approximately 36 weeks after study start
rate of RCB scored 0-1
Time frame: Up to approximately 36 weeks after study start
Objective Response Rate (ORR) Objective Response Rate (ORR) Objective Response Rate (ORR) Objective Response Rate (ORR)Objective Response Rate (ORR)
Time frame: Up to approximately 36 weeks after study start
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 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Chen, MD contact
Zhimin Shao, MD,PhD principal investigator
Breast cancer institute of Fudan University Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Albumin-bound paclitaxel and Doxorubicin in people with Early Breast Cancer and Neoadjuvant Therapy, 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 7 inclusion and 20 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 8 May 2024. 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 Zhimin Shao, MD, PhD (+86-021-64175590 ext. 88807, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pathological complete response (tpCR) rate using the definition of ypT0/Tis ypN0 (time frame: Up to approximately 36 weeks after study start). 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 8 May 2024.