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ACTIVE NOT RECRUITING
NCT02221999
PHASE2/PHASE3

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

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2013-09

Completion Date

2029-01

Last Updated

2023-08-29

Healthy Volunteers

No

Interventions

DRUG

Paclitaxel

DRUG

Cisplatin

DRUG

Gonadotropin-releasing hormone agonist

Goserelin 3.6 mg q28d or Leuprolide 11.25 mg q3m

DRUG

Letrozole

Locations (12)

Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital

Shenzhen, Guangdong, 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

Department of Medical Oncology, General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

Yueyang hospital of integrated traditional Chinese and Western medine

Shanghai, Shanghai Municipality, China

Armed Police Corps Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Zhoushan hospital

Zhoushan, Zhejiang, China