Breast CancerNCT01777932

AVAREG Study: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer

An observational study of Breast Cancer, run by Hoffmann-La Roche at 32 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
How many people: 220 participants
Where: 32 sitesHungary
Study dates: Dec 2007to Mar 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Patients with metastatic breast cancer initiated on treatment with Avastin in combination with paclitaxel

Who may be able to join

Patients with metastatic breast cancer initiated on first-line treatment with Avastin in combination with paclitaxel according to the current Hungarian summary of Product Characteristics
Patients with metastatic breast cancer initiated within 6 months before the start of the study on treatment with Avastin according to the current Hungarian Summary of Product Characteristics

Who cannot join

Contraindications for Avastin according to the current Hungarian Summary of Product Characteristics:
Hypersensitivity to active ingredient of Avastin or to any excipients
Hypersensitivity to products produced in Chinese hamster cells or to other recombinant or humanized antibodies
Pregnancy
Untreated central nervous system metastases

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

Hungary32 sites

Study site
Budapest, 1031
Study site
Budapest, 1076
Study site
Budapest, 1082
Study site
Budapest, 1088
Study site
Budapest, 1097
Study site
Budapest, 1106
Study site
Budapest, 1115
Study site
Budapest, 1122
Study site
Budapest, 1125
Study site
Budapest, 1135
Study site
Budapest, 1145
Study site
Debrecen, 4012
Study site
Debrecen, H-4031
Study site
Eger, 3300
Study site
Győr, 9023
Study site
Gyula, 5700
Study site
Kaposvár, 7400
Study site
Kecskemét, 6000
Study site
Kistarcsa, 2143
Study site
Miskolc, 3526
Study site
Nyíregyháza, 4400
Study site
Pécs, 7624
Study site
Salgótarján, 3100
Study site
Szeged, 6720
Study site
Székesfehérvár, 8000
Study site
Szekszárd, 7100
Study site
Szentes, 6600
Study site
Szolnok, 5004
Study site
Szombathely, 9700
Study site
Tatabánya, 2800
Study site
Veszprém, 8200
Study site
Zalaegerszeg, 8900

Other trials in Hungary

About this study

Official title: A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)

This multicenter, single-arm observational study will evaluate the clinical benefits of Avastin (bevacizumab) in combination with paclitaxel in first-line treatment in patients with metastatic breast cancer. Patients with metastatic breast cancer who have started Avastin treatment within 6 months prior to study start will also be eligible. Data will be collected from patients for up to 5 years.

Conditions: 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.

Study groups in NCT01777932
Study group	Role	What they receive
Cohort		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival
Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.
Measured: Approximately 5 years

Secondary outcomes (10)

One Year Survival
The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported.
Measured: Approximately 5 years
Time to Discontinuation (TTD) of Bevacizumab Treatment
Time to treatment discontinuation is defined as the time to change of therapy due to any cause (tumour progression, toxicity, or other causes) from the start of bevacizumab treatment.
Measured: Approximately 5 years
Participants With Hormone Receptor Status at Diagnosis
The hormone receptor status for Oestrogen (ER), Progesterone (PgR) and Human epidermal growth factor receptor (HER-2) is reported as positive, negative, unknown or missing.
Measured: Baseline (Day 1)
Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry
PFS was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment for participants with triple negative status and not triple negative status.
Measured: Approximately 5 years
Participants With Tumor Stage at Diagnosis
Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported.
Measured: Baseline (Day 1)
Participants With Eastern Cooperative Oncology Group Status at Study Entry
The Eastern Cooperative Oncology Group (ECOG) status for participants was categorized as 0, 1, 2, or missing. ECOG has 4 grades as: 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care, totally confined to bed/chair.
Measured: Baseline (Day 1)
Participants With Prior Therapy at Study Entry (Baseline)
The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported.
Measured: Baseline (Day 1)
Participants With Disease History at Study Entry (Baseline)
Participant's history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline).
Measured: Baseline (Day 1)
Participants With Type of Metastases at Study Entry (Baseline)
The type of metastases (bone and visceral) are reported at study entry (baseline) is reported.
Measured: Baseline (Day 1)
Participants With Proteinuria at Study Entry (Baseline)
The number of participants with proteinurea status as positive, negative or missing is reported.
Measured: Baseline (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Mar 2012

First posted29 Jan 2013 (estimated)
Study startDec 2007
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01777932
Sponsor's protocol ID: ML21647
Status last verified: Jan 2016
First submitted: 24 Jan 2013
Last updated: 5 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)
ClinicalTrials.gov ID: NCT01777932
Acronym / sponsor ID: ML21647
Conditions: Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 29 Jan 2013 (estimated)
Results: Posted 5 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with metastatic breast cancer initiated on treatment with Avastin in combination with paclitaxel

Key inclusion criteria (2 listed)

Patients with metastatic breast cancer initiated on first-line treatment with Avastin in combination with paclitaxel according to the current Hungarian summary of Product Characteristics
Patients with metastatic breast cancer initiated within 6 months before the start of the study on treatment with Avastin according to the current Hungarian Summary of Product Characteristics

Key exclusion criteria (5 listed)

Contraindications for Avastin according to the current Hungarian Summary of Product Characteristics:
Hypersensitivity to active ingredient of Avastin or to any excipients
Hypersensitivity to products produced in Chinese hamster cells or to other recombinant or humanized antibodies
Pregnancy
Untreated central nervous system metastases

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

Progression Free Survival
Time frame: Approximately 5 years
Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.

10 secondary outcomes

One Year Survival
Time frame: Approximately 5 years
Time to Discontinuation (TTD) of Bevacizumab Treatment
Time frame: Approximately 5 years
Participants With Hormone Receptor Status at Diagnosis
Time frame: Baseline (Day 1)
Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry
Time frame: Approximately 5 years
Participants With Tumor Stage at Diagnosis
Time frame: Baseline (Day 1)
Participants With Eastern Cooperative Oncology Group Status at Study Entry
Time frame: Baseline (Day 1)
Participants With Prior Therapy at Study Entry (Baseline)
Time frame: Baseline (Day 1)
Participants With Disease History at Study Entry (Baseline)
Time frame: Baseline (Day 1)
Participants With Type of Metastases at Study Entry (Baseline)
Time frame: Baseline (Day 1)
Participants With Proteinuria at Study Entry (Baseline)
Time frame: Baseline (Day 1)

Results and safety

Results posted to the registry on 5 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paclitaxel + Bevacizumab Arm	220	15

Primary outcome: Progression Free Survival

Time frame: Approximately 5 years. Median (95% Confidence Interval). Unit: months

Measure	Paclitaxel + Bevacizumab Arm n = 220
Value	9.3 (7.8 to 10.8)

Population analysed: All enrolled participants were considered for this outcome measure.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 5 years. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paclitaxel + Bevacizumab Arm	19 of 220 (8.6%)	68 of 220 (30.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Clinical Trials study director

Hoffmann-La Roche

32 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Hoffmann-La Roche at 32 sites in Hungary.

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 2 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 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Hungary. 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?

Yes. Results are posted in the registry (first posted 5 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (time frame: Approximately 5 years). 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 NCT01777932.

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 5 Feb 2016.