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

An observational study of Breast Cancer, run by Hoffmann-La Roche at 12 sites in Argentina.

Completed

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

Trial summary

This observational study will assess the median time of treatment duration and the safety of Avastin (bevacizumab) as first line treatment in patients with metastatic breast cancer. Data will be collected for approximately 24 months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
What is being tested?: Bevacizumab
How many people: 28 participants
Where: 12 sitesArgentina
Study dates: Jan 2010to Jul 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: Breast cancer patients with first line treatment with Avastin

Who may be able to join

Patients with metastatic breast cancer in first line treatment who have completed treatment with Avastin

Who cannot join

Patients not willing or unable to signed written consent form

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Argentina12 sites

Study site
Buenos Aires, B1708EIL
Study site
Buenos Aires, C1113AAC
Study site
Buenos Aires, C1116ABC
Study site
Buenos Aires, C1199ACI
Study site
Buenos Aires, C1414CEF
Study site
Buenos Aires, C1417DTB
Study site
Buenos Aires, C1426ANZ
Study site
Capital Federal, C1426ALV
Study site
La Pampa, 6300
Study site
Mar del Plata, 7600
Study site
Rosario, S2000DSK
Study site
San Miguel de Tucumán, T4000IAK

Other trials in Argentina

About this study

Official title: Avastin in First Line Metastatic or Recurrent Breast Cancer. Retrospective Phase IV Study

Conditions: Breast Cancer
Being tested: Bevacizumab
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
Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed.

Study groups in NCT01215123
Study group	Role	What they receive
Bevacizumab		Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Receives: Drug: Bevacizumab

What is being measured

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

Time to Disease Progression (TDP)
Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to a maximum of 36.4 months

Secondary outcomes (1)

Treatment Duration: Number of Bevacizumab Cycles
Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.
Measured: Up to a maximum of 36.4 months

Timeline

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

Jan 2010Jul 2012

First posted6 Oct 2010 (estimated)
Study startJan 2010
Primary completionJul 2012
Study completionJul 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: Retrospective
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215123
Sponsor's protocol ID: ML25100
Status last verified: Jan 2016
First submitted: 27 Sep 2010
Last updated: 22 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

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
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Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
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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

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Avastin in First Line Metastatic or Recurrent Breast Cancer. Retrospective Phase IV Study
ClinicalTrials.gov ID: NCT01215123
Acronym / sponsor ID: ML25100
Conditions: Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 6 Oct 2010 (estimated)
Results: Posted 22 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: Retrospective
Number of arms: 1

Arm	Type	Receives
Bevacizumab	–	Drug: BevacizumabParticipants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Breast cancer patients with first line treatment with Avastin

Key inclusion criteria (1 listed)

Patients with metastatic breast cancer in first line treatment who have completed treatment with Avastin

Key exclusion criteria (1 listed)

Patients not willing or unable to signed written consent form

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
BevacizumabParticipants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed.	Drug	Bevacizumab

Primary outcome

Time to Disease Progression (TDP)
Time frame: Up to a maximum of 36.4 months
Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

1 secondary outcome

Treatment Duration: Number of Bevacizumab Cycles
Time frame: Up to a maximum of 36.4 months

Results and safety

Results posted to the registry on 22 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
Bevacizumab	28	28

Primary outcome: Time to Disease Progression (TDP)

Time frame: Up to a maximum of 36.4 months. Median (Full Range). Unit: months

Measure	Bevacizumab n = 28
Value	15.3 (2.6 to 36.4)

Population analysed: All enrolled participants

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline up to 36.4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bevacizumab	10 of 28 (35.7%)	23 of 28 (82.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 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

12 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 12 sites in Argentina.

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 1 inclusion and 1 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 22 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 12 sites in Argentina. 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 22 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?

Time to Disease Progression (TDP) (time frame: Up to a maximum of 36.4 months). 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 NCT01215123.

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 22 Feb 2016.