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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031250076 | Registry Identifier | Japan Registry of Clinical Trials |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Based on the above, the investigators planned this trial to evaluate whether pembrolizumab + paclitaxel + bevacizumab therapy is more effective than pembrolizumab + paclitaxel therapy in PD-L1-positive triple negative breast cancer patients who relapse after receiving immune checkpoint inhibitors in the perioperative period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab + paclitaxel + bevacizumab | Experimental |
| |
| Pembrolizumab + paclitaxel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Protocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria. Pembrolizumab: Intravenous infusion(400 mg/body, every 6 weeks starting on Day 1 of Cycle 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Through protocol treatment discontinuation, approximately 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Through protocol treatment discontinuation, approximately 9 months | |
| Overall survival | Through study completion, approximately 3.5 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yukinori Ozaki | Contact | +81-3-3520-0111 | yukinori.ozaki@jfcr.or.jp | |
| Kazuki Nozawa | Contact | +81-52-851-5511 | k.nozawa@med.nagoya-cu.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Toshimi Takano | Cancer Institute Hospital of JFCR | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital Organization Nagoya Medical Center | Recruiting | Nagoya | Aichi-ken | 460-0001 | Japan |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Paclitaxel | Drug | Protocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria. Paclitaxel: Intravenous infusion(90 mg/m^2, on Days 1, 8, and 15, starting on Day 1 of Cycle 1 with a 28-day cycle) |
|
| Bevacizumab | Drug | Protocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria. Bevacizumabl: Intravenous infusion(10 mg/kg, on Days 1, and 15, starting on Day 1 of Cycle 1 with a 28-day cycle) |
|
| Disease control rate |
| Through protocol treatment discontinuation, approximately 9 months |
| Incidence of adverse events | Until 1 month after protocol treatment discontinuation, approximately 10 months |
| Nagoya University Hospital | Recruiting | Nagoya | Aichi-ken | 466-8560 | Japan |
|
| Nagoya City University Hospital | Recruiting | Nagoya | Aichi-ken | 467-8602 | Japan |
|
| Akita University Hospital | Not yet recruiting | Akita | Akita | 010-8543 | Japan |
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| National Cancer Center Hospital East | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
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| Gifu University Hospital | Recruiting | Gifu | Gifu | 501-1194 | Japan |
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| Hiroshima University Hospital | Recruiting | Hiroshima | Hiroshima | 734-8551 | Japan |
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| Hokkaido University Hospital | Recruiting | Sapporo | Hokkaido | 060-8648 | Japan |
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| Hyogo Cancer Center | Recruiting | Akashi-shi | Hyōgo | 673-8558 | Japan |
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| Okayama University Hospital | Recruiting | Okayama | Okayama-ken | 700-8558 | Japan |
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| Osaka International Cancer Institute | Recruiting | Osaka | Osaka | 541-8567 | Japan |
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| Osaka Metropolitan University Hospital | Recruiting | Osaka | Osaka | 545-0051 | Japan |
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| Kindai University Hospital | Recruiting | Sakai-shi | Osaka | 590-0197 | Japan |
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| Cancer Institute Hospital of JFCR | Recruiting | Koto-ku | Tokyo | 135-8550 | Japan |
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| SHOWA Medical University Hospital | Recruiting | Shinagawa-ku | Tokyo | 142-8666 | Japan |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |