Breast CancerPhase 2NCT00754351
Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer
A Phase 2 study testing Bevacizumab, Docetaxel and Gemcitabine in people with Breast Cancer, run by University Hospital of Crete at 2 sites in Greece.
Trial summary
This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab combination, administered biweekly, as salvage treatment in patients with metastatic and HER2 negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bevacizumab, Docetaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesGreece
- Study dates
- Sep 2008to Feb 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
- No HER2 overexpression or gene amplification
- At least one previous chemotherapy regimen for metastatic breast cancer
- Age ≥18 years
- Performance status (WHO) 0-2
- Life expectancy of at least 12 weeks
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- Measurable disease as defined by at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
- Performance status (WHO) 0-2
- Adequate liver function (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine <1.5 times the upper normal limit) and bone marrow ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 9 g/dL) function
- Written informed consent
Who cannot join
- Pregnant or lactating women
- Progressive brain metastases according to clinical or radiological criteria
- Brain metastases without prior radiation therapy
- Radiation therapy within the previous 4 weeks
- Previous radiation therapy to the only measurable lesion
- Proteinuria ≥ 500 mgr of protein daily
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- Uncontrolled hypertension
- Documented hemorrhagic diathesis or coagulation disorder
- Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension)
- Thrombotic event within the previous 6 months
- Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
- Major surgical procedure within the previous 4 weeks
- Presence of nonhealing wound or fracture
- Peripheral neuropathy > grade 2 according to the NCI CTCAE (version 3.0)
- Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)
- Uncontrolled infection
- Any serious, uncontrolled comorbidity on the investigator's judgment
- Other cancer within the previous 5 years, except non-melanoma skin cancer and in situ cervical cancer
- Serious psychiatric illness
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete
About this study
Official title: Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer
This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab combination, administered biweekly, as salvage treatment in patients with metastatic and HER2 negative breast cancer.
Read the detailed description
Docetaxel plus gemcitabine is an active combination in the salvage treatment for metastatic breast cancer. Administered every two weeks, this combination has a favorable toxicity profile, and promising activity in > 1st line treatment for metastatic breast cancer. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the addition of bevacizumab to a biweekly regimen of docetaxel and gemcitabine in the salvage therapy for metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab, Docetaxel, Gemcitabine
- Keywords
- docetaxel, gemcitabine, bevacizumab, 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.
BevacizumabDrug
Also called Avastin
Bevacizumab (IV) 10 mgr/Kgr on days 1 and 15 every 4 weeks for 6 cycles followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression
DocetaxelDrug
Also called Taxotere
Docetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
GemcitabineDrug
Also called Gemzar
Gemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bevacizumab->Docetaxel->Gemcitabine Receives: Drug: Bevacizumab; Drug: Docetaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: up to 6 months
Secondary outcomes (4)
Progression Free Survival
Measured: 1 year
Toxicity profile
Measured: 21 days
Overall Survival
Measured: 1 year
Quality of life assessment
Measured: Assessment every two cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2012
- Study completionFeb 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vassilis Georgoulias, MD, University Hospital of Crete
- Investigators
- Dimitris Mavrudis, MD, Principal investigator, University Hospital of Crete, Dep of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754351
- Sponsor's protocol ID
- CT/08.01
- Status last verified
- Jun 2012
- First submitted
- 17 Sep 2008
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00754351
- Acronym / sponsor ID
- CT/08.01
- Conditions
- Breast Cancer
- Keywords
- docetaxel, gemcitabine, bevacizumab, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital of CreteUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 Sep 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.
This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab combination, administered biweekly, as salvage treatment in patients with metastatic and HER2 negative breast cancer.
Detailed description
Docetaxel plus gemcitabine is an active combination in the salvage treatment for metastatic breast cancer. Administered every two weeks, this combination has a favorable toxicity profile, and promising activity in > 1st line treatment for metastatic breast cancer. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the addition of bevacizumab to a biweekly regimen of docetaxel and gemcitabine in the salvage therapy for 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 |
|---|---|---|
| 1 | Experimental | Drug: Bevacizumab, Drug: Docetaxel, Drug: GemcitabineBevacizumab->Docetaxel->Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
- No HER2 overexpression or gene amplification
- At least one previous chemotherapy regimen for metastatic breast cancer
- Age ≥18 years
- Performance status (WHO) 0-2
Key exclusion criteria (19 listed)
- Pregnant or lactating women
- Progressive brain metastases according to clinical or radiological criteria
- Brain metastases without prior radiation therapy
- Radiation therapy within the previous 4 weeks
- Previous radiation therapy to the only measurable lesion
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 |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab (IV) 10 mgr/Kgr on days 1 and 15 every 4 weeks for 6 cycles followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression | Drug | 1 |
| DocetaxelAlso: TaxotereDocetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles | Drug | 1 |
| GemcitabineAlso: GemzarGemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles | Drug | 1 |
Primary outcome
Overall response rate
Time frame: up to 6 months
4 secondary outcomes
Progression Free Survival
Time frame: 1 year
Toxicity profile
Time frame: 21 days
Overall Survival
Time frame: 1 year
Quality of life assessment
Time frame: Assessment every two cycles
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 28 Jun 2012.
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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.
Dimitris Mavrudis, MD principal investigator
University Hospital of Crete, Dep of Medical Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, Docetaxel and Gemcitabine in people with Breast Cancer, run by University Hospital of Crete at 2 sites in Greece.
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 10 inclusion and 19 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 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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: 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 28 Jun 2012.