Metastatic Breast CancerPhase 2NCT01550848
A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer
A Phase 2 study testing Abraxane and Gemcitabine in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Abraxane and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jun 2015
- 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
- Female between 18 and 70 years old;
- Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;
- ECOG (Eastern Cooperative Oncology Group) 0~1;
- Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L;
- Got ICF (Informed Consent Form) before enrollment;
- Life expectancy more than 12 weeks
Who cannot join
- Pregnant or breast-feeding women or positive serum pregnancy test;
- Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling;
- Participation in any investigational drug study within 4 weeks preceding treatment start;
- Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer;
- Serious uncontrolled intercurrent infections;
- Poor compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer
The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
Read the detailed description
This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Abraxane and Gemcitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abraxane and GemcitabineDrug
Also called Combined Chemotherapy
ABX (Abraxane) 125 mg/m2，intravenous infusion，30min，day 1, 8, 15
GEM (Gemcitabine) 800 mg/m2，intravenous infusion，30min，day 1, 8, 15
| Study group | Role | What they receive |
|---|---|---|
| Abraxane and Gemcitabine | Experimental | Abraxane and Gemcitabine Receives: Drug: Abraxane and Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: 8 weeks
Secondary outcomes (1)
number of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionJun 2015
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, MD;PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550848
- Sponsor's protocol ID
- Fudan BR2011-07
- Status last verified
- Sep 2015
- First submitted
- 27 Feb 2012
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Li Y, Zhao Y, Gong C, Xie Y, Hu X, Zhang J, Wang L, Zhang S, Cao J, Tao Z, Wang B. Cisplatin shows greater efficacy than gemcitabine when combined with nab-paclitaxel in metastatic triple-negative breast cancer. Sci Rep. 2019 Mar 5;9(1):3563. doi: 10.1038/s41598-019-39314-y.
PubMed 30837503Zhao Y, Lv F, Chen S, Wang Z, Zhang J, Zhang S, Cao J, Wang L, Cao E, Wang B, Hu X. Caveolin-1 expression predicts efficacy of weekly nab-paclitaxel plus gemcitabine for metastatic breast cancer in the phase II clinical trial. BMC Cancer. 2018 Oct 22;18(1):1019. doi: 10.1186/s12885-018-4936-y.
PubMed 30348118
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01550848
- Acronym / sponsor ID
- Fudan BR2011-07
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Mar 2012 (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.
The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
Detailed description
This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abraxane and Gemcitabine | Experimental | Drug: Abraxane and GemcitabineAbraxane and Gemcitabine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female between 18 and 70 years old;
- Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;
- ECOG (Eastern Cooperative Oncology Group) 0~1;
- Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L;
- Got ICF (Informed Consent Form) before enrollment;
Key exclusion criteria (6 listed)
- Pregnant or breast-feeding women or positive serum pregnancy test;
- Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling;
- Participation in any investigational drug study within 4 weeks preceding treatment start;
- Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer;
- Serious uncontrolled intercurrent infections;
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 |
|---|---|---|
| Abraxane and GemcitabineAlso: Combined ChemotherapyABX (Abraxane) 125 mg/m2，intravenous infusion，30min，day 1, 8, 15 GEM (Gemcitabine) 800 mg/m2，intravenous infusion，30min，day 1, 8, 15 | Drug | Abraxane and Gemcitabine |
Primary outcome
overall response rate
Time frame: 8 weeks
1 secondary outcome
number of adverse events
Time frame: 6 months
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 9 Sep 2015.
- Derived from this study: PubMed 30837503Li Y, Zhao Y, Gong C, Xie Y, Hu X, Zhang J, Wang L, Zhang S, Cao J, Tao Z, Wang B. Cisplatin shows greater efficacy than gemcitabine when combined with nab-paclitaxel in metastatic triple-negative breast cancer. Sci Rep. 2019 Mar 5;9(1):3563. doi: 10.1038/s41598-019-39314-y.
- Derived from this study: PubMed 30348118Zhao Y, Lv F, Chen S, Wang Z, Zhang J, Zhang S, Cao J, Wang L, Cao E, Wang B, Hu X. Caveolin-1 expression predicts efficacy of weekly nab-paclitaxel plus gemcitabine for metastatic breast cancer in the phase II clinical trial. BMC Cancer. 2018 Oct 22;18(1):1019. doi: 10.1186/s12885-018-4936-y.
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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.
Xichun Hu, MD;PhD 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 Abraxane and Gemcitabine 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 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: finished, as of the sponsor's last update on 9 Sep 2015. 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?
overall response rate (time frame: 8 weeks). 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 NCT01550848, 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 9 Sep 2015.