Thalidomide Plus Chemotherapy Versus Chemotherapy Alone for Advanced Breast Cancer
NCT ID: NCT02649101
Last Updated: 2016-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2015-10-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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thalidomide plus chemotherapy
thalidomide tablet 100mg qn po
Thalidomide
Thalidomide tablet 100mg qn po.
Physician's choice chemotherapy
Investigators will declare no constraint of regimens.
chemotherapy
Physician's choice chemotherapy. No constraints of the choice of chemotherapy drugs and regimens.
Physician's choice chemotherapy
Investigators will declare no constraint of regimens.
Interventions
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Thalidomide
Thalidomide tablet 100mg qn po.
Physician's choice chemotherapy
Investigators will declare no constraint of regimens.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed breast cancer with evidence of metastatic disease. (Note: the participant must be recovered from any clinically significant toxicity thereof last therapy.)
* ECOG performance status 0-2.
* Adequate bone marrow, kidney and liver function.
* ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
Exclusion Criteria
* Patients with HER2 positive disease.
* Untreated and/or uncontrolled brain metastases.
* Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
* Known HIV (Human Immunodeficiency Virus) infection.
* Pregnant or breast-feeding women.
* Bilateral invasive breast cancer.
* Cardiac and thrombotic disease or risk for same as judged by Investigator.
* Other serious illness or medical conditions such as (partial list- review with Investigator) history of significant neurologic or psychiatric disorders that would prohibit the understanding and giving of informed consent, active uncontrolled infection, active peptic ulcer, unstable diabetes mellitus or subjects with symptomatic, intrinsic lung disease resulting in dyspnea at rest.
18 Years
65 Years
FEMALE
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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LeiLei
Dr.
Principal Investigators
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xiaojia wang, doctor
Role: STUDY_CHAIR
Director
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZCHBC-007
Identifier Type: -
Identifier Source: org_study_id
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