Thalidomide Plus Chemotherapy Versus Chemotherapy Alone for Advanced Breast Cancer

NCT02649101 | Unknown Phase 2

• 1 other identifier: ZCHBC-007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival(PFS)

  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 Outcomes (1)

• 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.

Study Arms (2)

thalidomide plus chemotherapy

EXPERIMENTAL

thalidomide tablet 100mg qn po

Drug: Thalidomide; Drug: Physician's choice chemotherapy

chemotherapy

ACTIVE COMPARATOR

Physician's choice chemotherapy. No constraints of the choice of chemotherapy drugs and regimens.

Drug: Physician's choice chemotherapy

Interventions

Thalidomide DRUG

Thalidomide tablet 100mg qn po.

Also known as: Contergan

thalidomide plus chemotherapy

Physician's choice chemotherapy DRUG

Investigators will declare no constraint of regimens.

Also known as: no other name

chemotherapy; thalidomide plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• xiaojia wang, doctor

  Director

  STUDY CHAIR

Central Study Contacts

lei lei, master

CONTACT

+8613750802564; leilei1241@163.com

xiaojia wang, doctor

CONTACT

+8613906500190; wangxj@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: January 7, 2016
• Study Start: October 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

CN (1)