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This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Pyrotinib Plus trastuzumab and docetaxel |
|
| B | Placebo Comparator | Placebo plus trastuzumab and docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyrotinib, Trastuzumab, Docetaxel | Drug | Pyrotinib 400mg orally daily until progressive disease |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression Free Survival | Approximately 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| AEs+SAEs | Adverse Events and Serious Adverse Events | From the first drug administration to within 28 days for the last treatment |
| OS | Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital,Chinese Academy of Medical Science | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41839514 | Derived | Ma F, Yan M, Li W, Ouyang Q, Tong Z, Teng Y, Wang Y, Wang S, Geng C, Luo T, Zhong J, Zhang Q, Liu Q, Zeng X, Sun T, Mo Q, Zhou S, Li P, Cheng J, Wang X, Nie J, Yang J, Wu X, Wang X, Li H, Yao G, Fan Y, Lin J, Zhu X, Xu B. Pyrotinib or placebo in combination with trastuzumab and docetaxel for HER2 positive metastatic breast cancer: long term survival results from randomised phase 3 PHILA trial. BMJ. 2026 Mar 16;392:e087259. doi: 10.1136/bmj-2025-087259. | |
| 37907210 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000622954 | pyrotinib |
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo, Trastuzumab, Docetaxel |
| Drug |
Placebo 400mg orally daily until progressive disease |
|
| Up to 2 years |
| ORR | Objective Response Rate | Approximately 42 months |
| DoR | Duration of Objective Response | Approximately 42 months |
| CBR | Clinical Benefit rate | From the start of randomization to 6 months |
| Derived |
| Ma F, Yan M, Li W, Ouyang Q, Tong Z, Teng Y, Wang Y, Wang S, Geng C, Luo T, Zhong J, Zhang Q, Liu Q, Zeng X, Sun T, Mo Q, Liu H, Cheng Y, Cheng J, Wang X, Nie J, Yang J, Wu X, Wang X, Li H, Ye C, Dong F, Wu S, Zhu X, Xu B; PHILA Investigators. Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial. BMJ. 2023 Oct 31;383:e076065. doi: 10.1136/bmj-2023-076065. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |