Metastatic Breast CancerNCT01978977
Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy In Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer, run by Hellenic Oncology Research Group at 6 sites in Greece.
Trial summary
Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 400 participants
- Where
- 6 sitesGreece
- Study dates
- Jul 2011to Mar 2015
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinics for cancer prevention
Who may be able to join
- Written informed consent
- Age ≥18 years
- Patients with histologically or cytologically confirmed, HER2-negative, metastatic Breast Cancer
- No prior first line treatment for metastatic Breast Cancer
- Previous hormonotherapy for metastatic Breast Cancer is allowed
- One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
Show all 10Show fewer
- ECOG performance status ≤2
- Adequate haematological, renal and hepatic function
- Urine protein <2+ (dipstick)
- Life expectancy of ≥12 weeks
Who cannot join
- Previous first line treatment for metastatic colorectal cancer(progression >12 months after the end of adjuvant treatment)
- Previous radiotherapy to target lesions
- Patients with brain metastases and/or cancerous meningitis
- Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
- Patients participating in interventional clinical trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Greece6 sites
University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupoli
"IASO" General Hospital of Athens
Athens
Air Forces Military Hospital of Athens
Athens
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki
About this study
Official title: Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy Plus Bevacizumab in Women With HER2-Negative Metastatic Breast Cancer. An Observational Study.
Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic Breast Cancer.
Read the detailed description
Nowadays in clinical practice patients with previously untreated metastatic breast cancer often receive taxane-based chemotherapy (paclitaxel or docetaxel) in combination with bevacizumab as it has been shown to increase progression-free survival. There is currently minimal information whether bevacizumab should be given as maintenance therapy after discontinuation of chemotherapy.
- Conditions
- Metastatic Breast Cancer
- Keywords
- mBC, HER2 negative, Chemotherapy, Anti-angiogenic agent, Bevacizumab, 1st Line
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Avastin regimens | Patients who are going to receive chemotherapy plus Avastin (bevacizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
In this observational study investigators are going to assess standard schedules in which administration was every 2 or 3 weeks
Measured: Every 2 or 3 weeks up to 12 or 18 weeks
Secondary outcomes (3)
Number of Participants with Response Rate
In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 or 6 weeks
Measured: Disease evaluation at Week 3 or at week 6
Percentage of Patients with Progression Free Survival
Measured: 1 year
Patients Overall Survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startJul 2011
- Primary completionMar 2015
- Study completionMar 2015
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.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vassilis Georgoulias, MD, Principal investigator, Hellenic Oncology Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978977
- Sponsor's protocol ID
- CT/10.17
- Status last verified
- Oct 2015
- First submitted
- 3 Nov 2013
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy Plus Bevacizumab in Women With HER2-Negative Metastatic Breast Cancer. An Observational Study.
- ClinicalTrials.gov ID
- NCT01978977
- Acronym / sponsor ID
- CT/10.17
- Conditions
- Metastatic Breast Cancer
- Keywords
- mBC, HER2 negative, Chemotherapy, Anti-angiogenic agent, Bevacizumab, 1st Line
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Nov 2013 (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.
Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic Breast Cancer.
Detailed description
Nowadays in clinical practice patients with previously untreated metastatic breast cancer often receive taxane-based chemotherapy (paclitaxel or docetaxel) in combination with bevacizumab as it has been shown to increase progression-free survival. There is currently minimal information whether bevacizumab should be given as maintenance therapy after discontinuation of chemotherapy.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin regimens | – | –Patients who are going to receive chemotherapy plus Avastin (bevacizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinics for cancer prevention
Key inclusion criteria (10 listed)
- Written informed consent
- Age ≥18 years
- Patients with histologically or cytologically confirmed, HER2-negative, metastatic Breast Cancer
- No prior first line treatment for metastatic Breast Cancer
- Previous hormonotherapy for metastatic Breast Cancer is allowed
Key exclusion criteria (5 listed)
- Previous first line treatment for metastatic colorectal cancer(progression >12 months after the end of adjuvant treatment)
- Previous radiotherapy to target lesions
- Patients with brain metastases and/or cancerous meningitis
- Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
- Patients participating in interventional clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Adverse Events
Time frame: Every 2 or 3 weeks up to 12 or 18 weeks
In this observational study investigators are going to assess standard schedules in which administration was every 2 or 3 weeks
3 secondary outcomes
Number of Participants with Response Rate
Time frame: Disease evaluation at Week 3 or at week 6
Percentage of Patients with Progression Free Survival
Time frame: 1 year
Patients Overall Survival
Time frame: 1 year
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 7 Oct 2015.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Vassilis Georgoulias, MD principal investigator
Hellenic Oncology Research Group
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Hellenic Oncology Research Group at 6 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 5 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 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
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?
Number of Participants with Adverse Events (time frame: Every 2 or 3 weeks up to 12 or 18 weeks). 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 Oct 2015.