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This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 | Experimental | QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole |
|
| control | Active Comparator | CDK4/6 inhibitor + fulvestrant/letrozole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 | Drug | QL1706 is a single bifunctional MabPair product consisting of two engineered monoclonal antibodies (anti-PD-1 and anti-CTLA-4). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first. | From the date of starting study treatment to the date of first documentation of disease progression or death from any cause (up to approximately 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0. | From the date of starting study treatment to the end of the treatment (up to approximately 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjin Yin, M.D. | Contact | 86(21)68385569 | yinwenjin@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenjin Yin, M.D. | Renji Hospital,School of Medicine, Shanghai Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University | Recruiting | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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| CDK4/6 inhibitor | Drug | palbociclib OR ribociclib OR abemaciclib OR dalpiciclib |
|
| Fulvestrant | Drug | SERD |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |