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This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm1 | Experimental | Pyrotinib Plus trastuzumab and docetaxel |
|
| arm2 | Placebo Comparator | placebo plus trastuzumab and docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyrotinib | Drug | pyrotinib: 400mg orally daily; |
| |
| Placebo Oral Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites | Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4,each cycle is 21 days) | |
| Event-free survival(EFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China | ||
| The Fifth Medical Center of Chinese PLA General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36575513 | Derived | Wu J, Jiang Z, Liu Z, Yang B, Yang H, Tang J, Wang K, Liu Y, Wang H, Fu P, Zhang S, Liu Q, Wang S, Huang J, Wang C, Wang S, Wang Y, Zhen L, Zhu X, Wu F, Lin X, Zou J. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial. BMC Med. 2022 Dec 27;20(1):498. doi: 10.1186/s12916-022-02708-3. |
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| Drug |
placebo: 400mg orally daily; |
|
| Trastuzumab | Drug | trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles; |
|
| Docetaxel | Drug | docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles |
|
| Following surgery until Year 3 |
| Disease-free Survival (DFS) | Following surgery until Year 3 |
| Distance Disease-free Survival (DDFS) | Following surgery until Year 3 |
| Objective Response Rate (ORR) during neoadjuvant period | Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months |
| Beijing |
| Beijing Municipality |
| 100071 |
| China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| Sun Yet-Sen University Cancer Center | Guangzhou | Guangdong | 510010 | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510289 | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Huai'an First People's Hospital | Huaian | Jiangsu | 223001 | China |
| JiangSu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250000 | China |
| The Affiliated Hospital Of Qingdao University | Qingdao | Shandong | 266100 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| The Second Affiliated Hospital Of Xi'an Jiaotong University | Xian | Shanxi | 710004 | China |
| The First Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310005 | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| ID | Term |
|---|---|
| C000622954 | pyrotinib |
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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