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This is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | QL1706 plus carboplatin and albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 plus doxorubicin/epirubicin and cyclophosphamide (21-day cycles for 4 cycles) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy combined with chemotherapy | Drug | Albumin-bound paclitaxel: 125 mg/m², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg/kg, day 1, 21-day cycle; Epirubicin: 90-100 mg/m², day 1, 21-day cycle; or Doxorubicin: 50 mg/m², day 1, 21-day cycle; Cyclophosphamide: 600 mg/m², day 1, 21-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response (pCR) rates | pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer 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 American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery. | Up to approximately 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 | Up to approximately 27-30 weeks |
| 3y-EFS | Percentage of patients who, from the initiation of treatment, remain free of any of the following events within three years: disease progression to unresectable status, local or distant recurrence, development of a second primary malignancy (breast cancer or other cancers), or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;
Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
Stage IV metastatic breast cancer;
Administration of a vaccine within 30 days before the first dose of the study treatment;
Subjects with severe systemic diseases;
Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);
Severe cardiovascular diseases, such as: history of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the past 6 months; or congestive heart failure (CHF) of New York Heart Association (NYHA) class II-IV, or history of CHF NYHA class III or IV;
Lactating women should discontinue breastfeeding during the study;
Subjects with known allergies to the study drug or any of its excipients;
Any other condition deemed inappropriate for participation in the study by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Fan | Contact | 86+18912250939 | lflove2009@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Nantong University | Recruiting | Nantong | Jiangsu | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Up to approximately 3 years |
| Overall survival (OS) | OS is defined as the time from the initiation of treatment to death due to any cause. Participants without documented death at the time of the analysis will be censored at the date of the last follow-up. | Up to approximately 8 years |
| Adverse events | AEs will be assessed according to NCI CTCAE v5.0, by grade | up to 18 months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |