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The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.
In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the trastuzumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel and Cisplatin | Experimental | Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug |
|
| |
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response of breast and lymph nodes | after 4 months preoperative treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and Safety | Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped | 4 months during neoadjuvant therapy |
| Clinical and imaging response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China | ||
| Shanghai Jiaotong University School of Medicine, Renji Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38129778 | Derived | Wan C, Zhou L, Jin Y, Li F, Wang L, Yin W, Wang Y, Li H, Jiang L, Lu J. Strain ultrasonic elastography imaging features of locally advanced breast cancer: association with response to neoadjuvant chemotherapy and recurrence-free survival. BMC Med Imaging. 2023 Dec 21;23(1):216. doi: 10.1186/s12880-023-01168-2. | |
| 33154826 | Derived |
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| ID | Term |
|---|---|
| D018270 | Carcinoma, Ductal, Breast |
| D058922 | Inflammatory Breast Neoplasms |
| ID | Term |
|---|---|
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Drug |
|
To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment
| 4 months during treatment |
| regional recurrence free survival (RRFS) | RRFS is defined as the time period between registration and first event | 5 years |
| local recurrence free survival (LRFS) | LRFS is defined as the time period between registration and first event | 5 years |
| distant-disease- free survival (DDFS) | DFS is defined as the time period between registration and first event | 5 years |
| overall survival (OS) | OS is defined as the time period between registration and first event | 5 years |
| Shanghai |
| Shanghai Municipality |
| 200127 |
| China |
| Sun L, Yin W, Wu Z, Wang Y, Lu J. The Predictive Value of Pre-therapeutic Serum Gamma-glutamyl transferase in Efficacy and Adverse Reactions to Neoadjuvant Chemotherapy among Breast Cancer Patients. J Breast Cancer. 2020 Oct;23(5):509-520. doi: 10.4048/jbc.2020.23.e59. |
| 30976202 | Derived | Wu Z, Zhang L, Xu S, Lin Y, Yin W, Lu J, Sha R, Sheng X, Zhou L, Lu J. Predictive and prognostic value of ZEB1 protein expression in breast cancer patients with neoadjuvant chemotherapy. Cancer Cell Int. 2019 Mar 29;19:78. doi: 10.1186/s12935-019-0793-2. eCollection 2019. |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |