Breast CancerPhase 2BEVPACNCT01722968
A Biomarker Study in Patients With HER2-negative Metastatic Breast Cancer Treated With Bevacizumab and Paclitaxel
A Phase 2 study testing Bevacizumab and Paclitaxel in people with Breast Cancer, run by Theodoros Foukakis at 1 site in Sweden.
Trial summary
To explore molecular biomarkers and/or gene expression signatures that predict response to bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative metastatic breast cancer (MBC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bevacizumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2012to Jun 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years.
- Performance status ECOG 0-2.
- Clinically and / or radiologically proven stage IV or recurrent HER2 negative breast cancer.
- At least one tumor lesion accessible for biopsy. This lesion may not have been treated previously with irradiation.
- Clinically and/or radiographically documented measurable disease according to RECIST v1.1 criteria. At least one site of disease must be unidimensionally measurable as follows:
- CT-scan, physical exam ≥ 10 mm} Chest X-ray ≥ 20 mm }see Eisenhauer et al. for more details
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- Lymph node short axis ≥ 15 mm }
- All radiology studies must be performed within 28 days prior to registration (35 days if negative).
- Adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment:
- Haematology: Absolute granulocytes > 1.5 x 109/L Platelets > 100 x 109/L
- Biochemistry:Bilirubin within normal limits Serum creatinine within normal limits
- APTT and INR within normal limits within 7 days prior to enrollment.
- Adequate cardiac function with Left Ventricular Ejection Fraction (LVEF) within normal limits determined by echocardiogram or MUGA within 28 days prior to inclusion.
- Written informed consent must be given.
Who cannot join
- Previous systemic treatment for MBC.
- Major surgery less than 28 days prior to enrollment.
- Concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
- Bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs.
- Major cardiac comorbidity.
- Previous treatment with bevacizumab.
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- Previous allergic reaction to taxane analogs.
- Ongoing pregnancy or lactation.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Phase II Study to Identify Predictive Biomarkers and Mechanisms of Therapy Resistance in Patients With HER2-negative Metastatic Breast Cancer Treated With the Combination of Bevacizumab and Paclitaxel (BEVPAC).
To explore molecular biomarkers and/or gene expression signatures that predict response to bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative metastatic breast cancer (MBC).
Read the detailed description
This is a prospective, randomized, 2-arm, open-label, single-center, phase II trial. A total of 30 patients will be included during a period of 2 years.
The study will be initiated with a non-randomized, feasibility stage including ten patients who will be treated with bevacizumab and paclitaxel, in order to determine the safety of metastatic tumor biopsies during therapy with bevacizumab.
In the second phase, patients will be randomized (1:1) between two treatment arms: A. Bevacizumab + paclitaxel and B. Paclitaxel
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab, Paclitaxel
- Keywords
- Metastatic breast cancer
- 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
15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly
PaclitaxelDrug
Also called Paxene, Taxol
80mg/m2 iv weekly
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Arm A and feasibility phase: Bevacizumab 15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly. Receives: Drug: Bevacizumab; Drug: Paclitaxel |
| Arm B | Active comparator | Arm B: Paclitaxel 80mg/m2 iv weekly. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of molecular biomarkers
To explore molecular biomarkers and/or gene expression signatures that predict response to bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative MBC.
Measured: After the study completion,After completion of the study, which will take up to 3 years
Secondary outcomes (1)
Safety of metastatic biopsies during bevacizumab therapy
The safety objective of the study is to assess whether carrying out metastatic tissue biopsies during treatment with bevacizumab is safe. For this reason, the study will be initiated with a feasibility phase of 10 patients and will be continued to the randomized phase only if the study specific procedures prove to be safe.
Measured: continuous assessment and after inclusion of 10 patients, After completion of the study which will take up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2018
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodoros Foukakis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theodoros Foukakis, Karolinska University Hospital
- Investigators
- Theodoros Foukakis, MD PhD, Principal investigator, Karolinska University HospitalJonas Bergh, Professor, Study director, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722968
- Sponsor's protocol ID
- EudraCT no: 2012-003743-30
- Acronym
- BEVPAC
- Status last verified
- Feb 2019
- First submitted
- 22 Oct 2012
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Phase II Study to Identify Predictive Biomarkers and Mechanisms of Therapy Resistance in Patients With HER2-negative Metastatic Breast Cancer Treated With the Combination of Bevacizumab and Paclitaxel (BEVPAC).
- ClinicalTrials.gov ID
- NCT01722968
- Acronym / sponsor ID
- BEVPAC / EudraCT no: 2012-003743-30
- Conditions
- Breast Cancer
- Keywords
- Metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Theodoros FoukakisUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2018 (actual)
- First posted
- 7 Nov 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.
To explore molecular biomarkers and/or gene expression signatures that predict response to bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative metastatic breast cancer (MBC).
Detailed description
This is a prospective, randomized, 2-arm, open-label, single-center, phase II trial. A total of 30 patients will be included during a period of 2 years.
The study will be initiated with a non-randomized, feasibility stage including ten patients who will be treated with bevacizumab and paclitaxel, in order to determine the safety of metastatic tumor biopsies during therapy with bevacizumab.
In the second phase, patients will be randomized (1:1) between two treatment arms: A. Bevacizumab + paclitaxel and B. Paclitaxel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Bevacizumab, Drug: PaclitaxelArm A and feasibility phase: Bevacizumab 15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly. |
| Arm B | Active comparator | Drug: PaclitaxelArm B: Paclitaxel 80mg/m2 iv weekly. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18-70 years.
- Performance status ECOG 0-2.
- Clinically and / or radiologically proven stage IV or recurrent HER2 negative breast cancer.
- At least one tumor lesion accessible for biopsy. This lesion may not have been treated previously with irradiation.
- Clinically and/or radiographically documented measurable disease according to RECIST v1.1 criteria. At least one site of disease must be unidimensionally measurable as follows:
Key exclusion criteria (9 listed)
- Previous systemic treatment for MBC.
- Major surgery less than 28 days prior to enrollment.
- Concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
- Bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs.
- Major cardiac comorbidity.
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: Avastin15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly | Drug | Arm A |
| PaclitaxelAlso: Paxene, Taxol80mg/m2 iv weekly | Drug | Arm A, Arm B |
Primary outcome
Identification of molecular biomarkers
Time frame: After the study completion,After completion of the study, which will take up to 3 years
To explore molecular biomarkers and/or gene expression signatures that predict response to bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative MBC.
1 secondary outcome
Safety of metastatic biopsies during bevacizumab therapy
Time frame: continuous assessment and after inclusion of 10 patients, After completion of the study which will take up to 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 27 Feb 2019.
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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.
Theodoros Foukakis, MD PhD principal investigator
Karolinska University Hospital
Jonas Bergh, Professor study director
Karolinska University Hospital
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 Bevacizumab and Paclitaxel in people with Breast Cancer, run by Theodoros Foukakis at 1 site in Sweden.
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 14 inclusion and 9 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 27 Feb 2019. 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 Sweden. 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?
Identification of molecular biomarkers (time frame: After the study completion,After completion of the study, which will take up to 3 years). 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 27 Feb 2019.