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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02221999
Other study ID # RenJiH-BC-002
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 2013
Est. completion date January 2029

Study information

Verified date August 2023
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

In this trial, patients with ER and or PR positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status. Letrozole for the postmenopausal women and ovarian function suppression for the premenopausal women. Patients with triple negative breast cancer will be randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she is premenopausal. Postermenopausal patients with triple negative breast caner will only have neoadjuvant chemotherapy. Patients with Her2 overexpression can obtain anti-Her2 target therapy. This study has been amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine therapy.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Paclitaxel

Cisplatin

Gonadotropin-releasing hormone agonist
Goserelin 3.6 mg q28d or Leuprolide 11.25 mg q3m
Letrozole


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

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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