Breast CancerPhase 2NCT01483300
Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
A Phase 2 study testing lobaplatin and cisplatin in people with Breast Cancer, run by Harbin Medical University at 1 site in China.
Trial summary
Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- lobaplatin and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Nov 2014
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic breast cancer
- Disease progression during or after previous 1st line chemotherapy
- Scheduled to receive 2nd line chemotherapy.
- Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
- 18 years of age or older
- ECOG performance status of 0-2
- Life expectancy of greater than 6 months
Who cannot join
- Previous treatment with one of the study drugs
- Application of other cytotoxic chemotherapy or radiotherapy
- Insufficent renal function (creatinine clearance < 60ml/min)
- Clinically unstable brain metastasis
- Pregancy or lactation
- History of other malignancy within last 5 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
Qingyuan Zhang, MD, 86-451-86298276, zhma19650210@163.com
Xinmei Kang, MD, 86-451-86298683, kxm791107@163.com
About this study
Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- lobaplatin, cisplatin
- Keywords
- breast cancer, gemcitabine, lobaplatin, cisplatin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lobaplatinDrug
Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
cisplatinDrug
Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| lobaplatin | Experimental | gemcitabine plus lobaplatin Receives: Drug: lobaplatin |
| cisplatin | Active comparator | gemcitabine plus cisplatin Receives: Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
Measured: 4 weeks after chemotherapy
Secondary outcomes (3)
Time to progression
Time to progression defined as time from randomization to disease progress.
Measured: one year after last patient in
Overall Survival
Overall survival defined as time from randomization to death from any cause.
Measured: one year after last patient in
Treatment related toxicity
Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system.
Measured: 4 weeks after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingyuan Zhang, Harbin Medical University
- Investigators
- Qingyuan Zhang, MD, Study director, Cancer Hospital of Harbin Medical UniversityXinmei Kang, MD, Principal investigator, Cancer Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483300
- Sponsor's protocol ID
- BC001
- Status last verified
- Jan 2012
- First submitted
- 25 Nov 2011
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01483300
- Acronym / sponsor ID
- BC001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, gemcitabine, lobaplatin, cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 1 Dec 2011 (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.
Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lobaplatin | Experimental | Drug: lobaplatingemcitabine plus lobaplatin |
| cisplatin | Active comparator | Drug: cisplatingemcitabine plus cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed metastatic breast cancer
- Disease progression during or after previous 1st line chemotherapy
- Scheduled to receive 2nd line chemotherapy.
- Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
- 18 years of age or older
Key exclusion criteria (6 listed)
- Previous treatment with one of the study drugs
- Application of other cytotoxic chemotherapy or radiotherapy
- Insufficent renal function (creatinine clearance < 60ml/min)
- Clinically unstable brain metastasis
- Pregancy or lactation
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 |
|---|---|---|
| lobaplatinGemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks | Drug | lobaplatin |
| cisplatinGemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks | Drug | cisplatin |
Primary outcome
Overall response rate
Time frame: 4 weeks after chemotherapy
Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
3 secondary outcomes
Time to progression
Time frame: one year after last patient in
Overall Survival
Time frame: one year after last patient in
Treatment related toxicity
Time frame: 4 weeks after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Qingyuan Zhang, MD study director
Cancer Hospital of Harbin Medical University
Xinmei Kang, MD principal investigator
Cancer Hospital of Harbin Medical University
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 lobaplatin and cisplatin in people with Breast Cancer, run by Harbin Medical University 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?
The sponsor lists 7 inclusion and 6 exclusion criteria. 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 24 Jan 2012. 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 Qingyuan Zhang, MD (86-451-86298276, zhma19650210@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 4 weeks after chemotherapy). 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 24 Jan 2012.