Metastatic Breast CancerPhase 2NCT00601159
Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
A Phase 2 study testing gemcitabine and cisplatin in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as first line therapy in patients with triple-negative MBC. 80 patients will be treated into this study. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- gemcitabine and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Sep 2007to Sep 2010
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice
- Be female and ≥18 and ≤75 years of age
- Be ambulatory and have ECOG performance stastus of ≤1
- Have histological confirmed breast cancer,and the speciman confirmed ER negative,PR negatiev, and HER-2 negative by immunochemistry technich of Fudan cancer hospital.
- Locally advanced or metastastic breast cancer who didn't receive first-line chemotherapy. No matter whether the patient has received anthracyclin or taxane treatment as neo-adjuvant or adjuvant treatment.
- Have at least one target lesion according to the RECIST criteria.
Who cannot join
- Preganant or lactating women
- Advaced patient has received one or more chemotherapies
- Chemotherapy within four weeks preceding treatment start
- ECOG ≥ 2
- Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy
- Participation in any investigational drug study within 4 weeks preceeding treatment start
Show all 15Show fewer
- Evidence of CNS metastasis
- History of another malignacy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
- Abnormal laboratory values: hemoglobin < 8. 0g/dl, neutrophil< 1.5×109/L, platelet< 100×109/L.
- serum creatine > upper limit of normal (ULN)
- serum bilirubin > ULN
- ALT and AST >5×ULN
- AKP >5×ULN
- Serious uncontrolled intercurrence infection
- Life expectancy of less than 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, +86200032
About this study
Official title: Phase Ⅱ Study of Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as first line therapy in patients with triple-negative MBC. 80 patients will be treated into this study.
Read the detailed description
Triple-negative breast tumors could contribute to the poor prognosis comparing with luminal A breast cancer.Fewer study has revealed that Cisplatin-based therapy may be effective for this type breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- gemcitabine and cisplatin
- Keywords
- Metastatic Breast Cancer, triple-negative Breast Cancer, cisplatin, chemotherapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine and cisplatinDrug
Also called gemzar
Cispaltin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 repeat every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine and cisplatin | Experimental | cisplatin and gemcitabine in the management of triple negative metastatic breast cancer Receives: Drug: gemcitabine and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (progression free survival)
Measured: 1 year
Secondary outcomes (3)
side effects
Measured: 6 months
BRCA1 mutation realtionship with efficacy and toxicity analysis
Measured: at the end of therapy
pharmacogenetic analysis
Measured: collect blood samples before therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionMay 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Zhonghua Wang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601159
- Sponsor's protocol ID
- 200709GP
- Status last verified
- Jun 2011
- First submitted
- 26 Dec 2007
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Turner NC, Reis-Filho JS, Russell AM, Springall RJ, Ryder K, Steele D, Savage K, Gillett CE, Schmitt FC, Ashworth A, Tutt AN. BRCA1 dysfunction in sporadic basal-like breast cancer. Oncogene. 2007 Mar 29;26(14):2126-32. doi: 10.1038/sj.onc.1210014. Epub 2006 Oct 2.
PubMed 17016441Zhang J, Wang Z, Hu X, Wang B, Wang L, Yang W, Liu Y, Liu G, Di G, Hu Z, Wu J, Shao Z. Cisplatin and gemcitabine as the first line therapy in metastatic triple negative breast cancer. Int J Cancer. 2015 Jan 1;136(1):204-11. doi: 10.1002/ijc.28966. Epub 2014 May 23.
PubMed 24824628
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Study of Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
- ClinicalTrials.gov ID
- NCT00601159
- Acronym / sponsor ID
- 200709GP
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, triple-negative Breast Cancer, cisplatin, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 25 Jan 2008 (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.
Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as first line therapy in patients with triple-negative MBC. 80 patients will be treated into this study.
Detailed description
Triple-negative breast tumors could contribute to the poor prognosis comparing with luminal A breast cancer.Fewer study has revealed that Cisplatin-based therapy may be effective for this type breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gemcitabine and cisplatin | Experimental | Drug: gemcitabine and cisplatincisplatin and gemcitabine in the management of triple negative metastatic breast cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice
- Be female and ≥18 and ≤75 years of age
- Be ambulatory and have ECOG performance stastus of ≤1
- Have histological confirmed breast cancer,and the speciman confirmed ER negative,PR negatiev, and HER-2 negative by immunochemistry technich of Fudan cancer hospital.
- Locally advanced or metastastic breast cancer who didn't receive first-line chemotherapy. No matter whether the patient has received anthracyclin or taxane treatment as neo-adjuvant or adjuvant treatment.
Key exclusion criteria (15 listed)
- Preganant or lactating women
- Advaced patient has received one or more chemotherapies
- Chemotherapy within four weeks preceding treatment start
- ECOG ≥ 2
- Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy
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 |
|---|---|---|
| gemcitabine and cisplatinAlso: gemzarCispaltin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 repeat every 3 weeks | Drug | gemcitabine and cisplatin |
Primary outcome
PFS (progression free survival)
Time frame: 1 year
3 secondary outcomes
side effects
Time frame: 6 months
BRCA1 mutation realtionship with efficacy and toxicity analysis
Time frame: at the end of therapy
pharmacogenetic analysis
Time frame: collect blood samples before therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2011.
- Background: PubMed 17016441Turner NC, Reis-Filho JS, Russell AM, Springall RJ, Ryder K, Steele D, Savage K, Gillett CE, Schmitt FC, Ashworth A, Tutt AN. BRCA1 dysfunction in sporadic basal-like breast cancer. Oncogene. 2007 Mar 29;26(14):2126-32. doi: 10.1038/sj.onc.1210014. Epub 2006 Oct 2.
- Derived from this study: PubMed 24824628Zhang J, Wang Z, Hu X, Wang B, Wang L, Yang W, Liu Y, Liu G, Di G, Hu Z, Wu J, Shao Z. Cisplatin and gemcitabine as the first line therapy in metastatic triple negative breast cancer. Int J Cancer. 2015 Jan 1;136(1):204-11. doi: 10.1002/ijc.28966. Epub 2014 May 23.
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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.
Zhonghua Wang, MD principal investigator
Fudan 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 gemcitabine and cisplatin in people with Metastatic Breast Cancer, run by Fudan 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 4 Jul 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (progression free survival) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00601159, which also lists 2 linked publications.
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 4 Jul 2011.