Inflammatory Breast Cancer Clinical Trial
— SHPD002Official title:
A Prospective, Randomized, Open-label Comparison of Preoperative Weekly Paclitaxel and Cisplatin With or Without Endocrine Therapy in Patients With Operable Hormone Receptor Positive and Triple Negative Locally Advanced Breast Cancer
Verified date | August 2023 |
Source | RenJi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer. In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate. Premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.
Status | Active, not recruiting |
Enrollment | 250 |
Est. completion date | January 2029 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Women aged =18years and =70 years; 2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size =2 cm, T2-4 N0-3M0; 3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as >1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals >2.0 or HER2 gene copy >6.0. 4. No prior systemic or loco-regional treatment of breast cancer; 5. Adequate bone marrow function:WBC=4.0×109/L, Absolute neutrophil count(ANC)=1.5×109/L, Platelets(PLT)=100×109/L, Hemoglobin(Hb)=90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)=1.5 upper normal limit (UNL), creatinine=1.5 UNL, bilirubin=1.5UNL; 6. No obvious main organs dysfunction. Exclusion Criteria: 1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug; 2. Patient is pregnant or breast feeding; 3. Inflammatory breast cancer and metastatic breast cancer; 4. Any evidence of sense or motor nerve disorders; 5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection; 6. Any concurrent malignancy other than breast cancer; 7. Know severe hypersensitivity to any drugs in this study. |
Country | Name | City | State |
---|---|---|---|
China | HanDan Central Hospital | Handan | Hebei |
China | The First Affiliated Hospital of University of South China | Hengyang | Hunan |
China | Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage | Hohhot | Inner Mongolia |
China | The second people's hospital of Kunshan city | Kunshan | Jiangsu |
China | Armed Police Corps Hospital of Shanghai | Shanghai | Shanghai |
China | Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University | Shanghai | Shanghai |
China | Shanghai Jiaotong University School of Medicine, Renji Hospital | Shanghai | Shanghai |
China | Yueyang hospital of integrated traditional Chinese and Western medine | Shanghai | Shanghai |
China | Zhongshan Hospital | Shanghai | Shanghai |
China | Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital | Shenzhen | Guangdong |
China | Department of Medical Oncology, General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
China | Zhoushan hospital | Zhoushan | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pathological complete remission rate | Pathological complete remission is defined as no invasive cancer in breast and axillary nodes. | after 4 months preoperative treatment | |
Secondary | Number of Participants With Drug Related Treatment Adverse Events | Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. | 4 months during neoadjuvant therapy | |
Secondary | Clinical and imaging response | 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 | |
Secondary | disease free survival (DFS) | DFS is defined as the time in months from randomization until first occurrence of locoregional recurrence, distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause. | 5 years | |
Secondary | regional recurrence free survival (RRFS) | RRFS is defined as the time period between registration and first event | 5 years | |
Secondary | local recurrence free survival (LRFS) | LRFS is defined as the time period between registration and first event | 5 years | |
Secondary | overall survival (OS) | OS is defined as the time period between registration and first event | 5 years | |
Secondary | distant-disease- free survival (DDFS) | DDFS is defined as the time period between registration and first event | 5 years | |
Secondary | rate of tumor remission (RTR) | RTR is defined as the proportion of tumor remission per unit time | after 2 cycles and 4 cycles during neoadjuvant therapy | |
Secondary | serum markers | Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery | Pre-treatment and/or surgical | |
Secondary | molecular markers | Pre-treatment and surgical expression of molecular markers (LHRHa receptor, EGFR,PD-L1) | Pre-treatment and/or surgical |
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