Trastuzumab Combined With Chemotherapy or Endocrine Therapy to Treat Metastatic Luminal B2 Breast Cancer (SYSUCC-002)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01950182|
Recruitment Status : Recruiting
First Posted : September 25, 2013
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Endocrine therapy combined with trastuzumab Drug: Chemotherapy combined with trastuzumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||392 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype|
|Actual Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Palliative chemotherapy
Chemotherapy combined with trastuzumab. Chemotherapy could use the following drugs such as capecitabine , Vinorelbine, or Gemcitabine.
Drug: Chemotherapy combined with trastuzumab
Capecitabine , Vinorelbine, or Gemcitabine combined with trastuzumab
Experimental: Palliative endocrine therapy
Endocrine therapy combined with trastuzumab. Endocrine therapy could use tamoxifen or aromatase inhibitors including anastrozole, letrozole, or exemestane.
Drug: Endocrine therapy combined with trastuzumab
Tamoxifen or aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) combined with trastuzumab
- progression-free survival (PFS) [ Time Frame: 36 months ]The interim analysis and the final analysis are expected ot occur 18 and 36 months after the end of recruitment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950182
|Contact: Zhong-yu Yuan, MDemail@example.com|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Zhong-yu Yuan, MD 86-20-87343794 firstname.lastname@example.org|
|Study Chair:||Zhong-yu Yuan, MD||Sun Yat-sen University|