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Clinical Trials in China / NCT02221999
Active, not recruiting Phase 2/3

Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients

NCT02221999 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Phase 2/3
Started
2013-09
Last updated
2023-08-29

Condition(s) studied

Tubular Breast CancerMucinous Breast CancerInvasive Ductal Breast CancerInflammatory Breast Cancer

Investigational drug(s) / intervention(s)

PaclitaxelCisplatinGonadotropin-releasing hormone agonistLetrozole

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital Shenzhen Guangdong
HanDan Central Hospital Handan Hebei
The First Affiliated Hospital of University of South China Hengyang Hunan
Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage Hohhot Inner Mongolia
The second people's hospital of Kunshan city Kunshan Jiangsu
Department of Medical Oncology, General Hospital of Ningxia Medical University Yinchuan Ningxia
Zhongshan Hospital Shanghai Shanghai Municipality
Shanghai Jiaotong University School of Medicine, Renji Hospital Shanghai Shanghai Municipality
Yueyang hospital of integrated traditional Chinese and Western medine Shanghai Shanghai Municipality
Armed Police Corps Hospital of Shanghai Shanghai Shanghai Municipality
Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University Shanghai Shanghai Municipality
Zhoushan hospital Zhoushan Zhejiang

More RenJi Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02221999 on ClinicalTrials.gov ↗ ← All trials in China