Metastatic Breast CancerPhase 2NCT02649101
Thalidomide Plus Chemotherapy Versus Chemotherapy Alone for Advanced Breast Cancer
A Phase 2 study testing Thalidomide and Physician's choice chemotherapy in people with Metastatic Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Thalidomide and Physician's choice chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiaojia Wang, PHD, 86 13906500190, wxiaojia0803@163.com
Jian Huang, Doctor, 86 13588048995, huang_jian22@aliyun.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Thalidomide, Physician's choice chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Also called Contergan
Thalidomide tablet 100mg qn po.
Physician's choice chemotherapyDrug
Also called no other name
Investigators will declare no constraint of regimens.
| Study group | Role | What they receive |
|---|---|---|
| thalidomide plus chemotherapy | Experimental | thalidomide tablet 100mg qn po Receives: Drug: Thalidomide; Drug: Physician's choice chemotherapy |
| chemotherapy | Active comparator | Physician's choice chemotherapy. No constraints of the choice of chemotherapy drugs and regimens. Receives: Drug: Physician's choice chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival(PFS)
PFS is defined as the months that from the anticipation of the clinical-trial to the progress of breast cancer.
Measured: 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)
OS is defined as the months that from the anticipation of the clinical-trial to the death of patients.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LeiLei, Zhejiang Cancer Hospital
- Investigators
- xiaojia wang, doctor, Study chair, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649101
- Sponsor's protocol ID
- ZCHBC-007
- Status last verified
- Jan 2016
- First submitted
- 13 Dec 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide Plus Chemotherapy Versus Chemotherapy Alone: A Phase II Study in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT02649101
- Acronym / sponsor ID
- ZCHBC-007
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thalidomide plus chemotherapy | Experimental | Drug: Thalidomide, Drug: Physician's choice chemotherapythalidomide tablet 100mg qn po |
| chemotherapy | Active comparator | Drug: Physician's choice chemotherapyPhysician's choice chemotherapy. No constraints of the choice of chemotherapy drugs and regimens. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThalidomideAlso: ConterganThalidomide tablet 100mg qn po. | Drug | thalidomide plus chemotherapy |
| Physician's choice chemotherapyAlso: no other nameInvestigators will declare no constraint of regimens. | Drug | chemotherapy, thalidomide plus chemotherapy |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiaojia wang, doctor study chair
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide and Physician's choice chemotherapy in people with Metastatic Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lei lei, master (+8613750802564, leilei1241@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.