Spots Global Cancer Trial Database for Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
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Trial Identification
Brief Title: Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
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
Study ID: NCT02221999
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, China
Shanghai Jiaotong University School of Medicine, Renji Hospital, Shanghai, Shanghai, China
Yueyang hospital of integrated traditional Chinese and Western medine, Shanghai, Shanghai, China
Armed Police Corps Hospital of Shanghai, Shanghai, Shanghai, China
Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, Shanghai, China
Zhoushan hospital, Zhoushan, Zhejiang, China
Contact Details
Name: Jinsong Lu
Affiliation: RenJi Hospital
Role: PRINCIPAL_INVESTIGATOR
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