Thalidomide Plus Chemotherapy Versus Chemotherapy Alone for Advanced Breast Cancer

Phase 2

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Physician's choice chemotherapy; Drug: Thalidomide

• Registration Number: NCT02649101
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

Sixty advanced breast cancer patients are planed to enrolled in this clinical trial. Forty patients are enrolled into thalidomide plus chemotherapy group. Twenty patients are enrolled into chemotherapy alone group. There is no restriction on chemotherapy regimen and lines.

Detailed Description

The study compares the combination of thalidomide and chemotherapy with chemotherapy alone for the treatment of stage IV breast cancer. Efficacy and safety of the chemotherapy-thalidomide combination will be evaluated. Assessing the isolated effects of thalidomide in a setting where pre and post treatment serum specimens can be obtained will provide essential information about the mechanisms by which vascular endothelial growth factor(VEGF) inhibition affects tumor growth, and represents an ideal opportunity to evaluate the molecular effects of thalidomide on breast tumor.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-13
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-05
• Last Update Submitted: 2016-01-05
• Study First Posted: 2016-01-07
• Last Update Posted: 2016-01-07
• Primary Completion: 2017-06
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chemotherapy	Physician's choice chemotherapy	Physician's choice chemotherapy. No constraints of the choice of chemotherapy drugs and regimens.
thalidomide plus chemotherapy	Physician's choice chemotherapy	thalidomide tablet 100mg qn po
thalidomide plus chemotherapy	Thalidomide	thalidomide tablet 100mg qn po

Primary Outcome Measures

Name	Time	Method
Progression free survival(PFS)	Change from Baseline RECIST at 6 months was assessed every 6 weeks up to 24 weeks. Data collection is from date of randomization until the date of first documented progression assessed up to 6 months.	PFS is defined as the months that from the anticipation of the clinical-trial to the progress of breast cancer.

Secondary Outcome Measures

Name	Time	Method
Overall survival(OS)	Survival assessed every 8 weeks up to 100 months following objective disease progression. Data collection is from date of randomization until the date of death from any cause, assessed up to 100 months.	OS is defined as the months that from the anticipation of the clinical-trial to the death of patients.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China