Thalidomide Plus Chemotherapy Versus Chemotherapy Alone for Advanced Breast Cancer

January 5, 2016 updated by: LeiLei, Zhejiang Cancer Hospital

Thalidomide Plus Chemotherapy Versus Chemotherapy Alone: A Phase II Study in Advanced Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xiaojia Wang, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  1. inclusion criteria:

    • Women >/= 18 and < 65 years of age .
    • 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.

  2. exclusion criteria:

    • Prior treatment with thalidomide.
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: thalidomide plus chemotherapy
thalidomide tablet 100mg qn po
Drug: Thalidomide
Thalidomide tablet 100mg qn po.
Other Names:
  • Contergan
Drug: Physician's choice chemotherapy
Investigators will declare no constraint of regimens.
Other Names:
  • no other name
Active Comparator: chemotherapy
Physician's choice chemotherapy. No constraints of the choice of chemotherapy drugs and regimens.
Drug: Physician's choice chemotherapy
Investigators will declare no constraint of regimens.
Other Names:
  • no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival(PFS)
Time Frame: 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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival(OS)
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Study Chair: xiaojia wang, doctor, Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

December 13, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZCHBC-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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