Breast CancerPhase 2NCT00846027

A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

A Phase 2 study testing Bevacizumab, Paclitaxel and Gemcitabine in people with Breast Cancer, run by Hoffmann-La Roche at 23 sites in Spain.

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, women only
Conditions the study is for: Breast Cancer
What is being tested?: Bevacizumab, Paclitaxel and Gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 23 sitesSpain
Study dates: Jan 2009to Jan 2013
Phase: Phase 2
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients, ≥ 18 years of age.
Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
HER-2 negative disease.
Candidates for chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Who cannot join

Previous chemotherapy for metastatic or locally advanced breast cancer.
Previous radiotherapy for treatment of metastatic breast cancer.
Any prior adjuvant treatment with anthracyclines completed < 6 months prior to enrollment.
Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (> 325 mg/day) or clopidogrel (> 75mg/day).

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

Spain23 sites

Study site
Alcorcón, Madrid, 28922
Study site
Barcelona, Barcelona, 08022
Study site
Barcelona, Barcelona, 08907
Study site
Burgos, Burgos, 09006
Study site
Cadiz, Cadiz, 11009
Study site
Córdoba, Cordoba, 14004
Study site
Elda, Alicante, 03600
Study site
Granada, Granada, 18003
Study site
Granada, Granada, 18014
Study site
Huelva, Huelva, 21005
Study site
Jaén, Jaen, 23007
Study site
Las Palmas de Gran Canaria, Las Palmas, 35016
Study site
Lugo, Lugo, 27004
Study site
Madrid, Madrid, 28041
Study site
Madrid, Madrid, 28222
Study site
Manresa, Barcelona, 08243
Study site
Marbella, Malaga, 29600
Study site
Murcia, Murcia, 30008
Study site
Sagunto, Valencia, 46520
Study site
Seville, Sevilla, 41009
Study site
Seville, Sevilla, 41014
Study site
Vigo, Pontevedra, 36214
Study site
Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: An Open Label Study to Assess the Effect of First Line Treatment With Avastin in Combination With Paclitaxel and Gemcitabine in Progression-free Survival in Patients With HER-2 Negative Breast Cancer

This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.

Conditions: Breast Cancer
Being tested: Bevacizumab, Paclitaxel, Gemcitabine
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 was supplied as a sterile liquid in glass vials.
PaclitaxelDrug
Also called Taxol
Paclitaxel was supplied as a sterile liquid in glass vials.
GemcitabineDrug
Also called Gemzar
Gemcitabine was supplied as a sterile liquid in glass vials.

Study groups in NCT00846027
Study group	Role	What they receive
Bevacizumab + paclitaxel + gemcitabine	Experimental	Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent. Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Gemcitabine

What is being measured

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

Progression-free Survival
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Measured: Baseline to the end of the study (up to 2 years 10 months)

Secondary outcomes (3)

Percentage of Participants With an Objective Response
An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
Measured: Baseline to the end of the study (up to 2 years 10 months)
Duration of the Objective Response
Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Measured: Baseline to the end of the study (up to 2 years 10 months)
Overall Survival
Overall survival is defined as the time from the first dose of study medication until death.
Measured: Baseline to the end of the study (up to 2 years 10 months)

Timeline

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

Jan 2009Jan 2013

First posted18 Feb 2009 (estimated)
Study startJan 2009
Primary completionDec 2011
Study completionJan 2013

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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00846027
Sponsor's protocol ID: ML21999
Other IDs: 2008-003657-32, 2008
Status last verified: Jul 2014
First submitted: 17 Feb 2009
Last updated: 23 Jul 2014
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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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study to Assess the Effect of First Line Treatment With Avastin in Combination With Paclitaxel and Gemcitabine in Progression-free Survival in Patients With HER-2 Negative Breast Cancer
ClinicalTrials.gov ID: NCT00846027
Acronym / sponsor ID: ML21999
Conditions: Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Dec 2011 (actual)
Study completion: Jan 2013 (actual)
First posted: 18 Feb 2009 (estimated)
Results: Posted 26 Jun 2014

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bevacizumab + paclitaxel + gemcitabine	Experimental	Drug: Bevacizumab, Drug: Paclitaxel, Drug: GemcitabineParticipants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Female patients, ≥ 18 years of age.
Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
HER-2 negative disease.
Candidates for chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Key exclusion criteria (4 listed)

Previous chemotherapy for metastatic or locally advanced breast cancer.
Previous radiotherapy for treatment of metastatic breast cancer.
Any prior adjuvant treatment with anthracyclines completed < 6 months prior to enrollment.
Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (> 325 mg/day) or clopidogrel (> 75mg/day).

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 was supplied as a sterile liquid in glass vials.	Drug	Bevacizumab + paclitaxel + gemcitabine
PaclitaxelAlso: TaxolPaclitaxel was supplied as a sterile liquid in glass vials.	Drug	Bevacizumab + paclitaxel + gemcitabine
GemcitabineAlso: GemzarGemcitabine was supplied as a sterile liquid in glass vials.	Drug	Bevacizumab + paclitaxel + gemcitabine

Primary outcome

Progression-free Survival
Time frame: Baseline to the end of the study (up to 2 years 10 months)
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.

3 secondary outcomes

Percentage of Participants With an Objective Response
Time frame: Baseline to the end of the study (up to 2 years 10 months)
Duration of the Objective Response
Time frame: Baseline to the end of the study (up to 2 years 10 months)
Overall Survival
Time frame: Baseline to the end of the study (up to 2 years 10 months)

Results and safety

Results posted to the registry on 26 Jun 2014, 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 + Paclitaxel + Gemcitabine	90	0

Primary outcome: Progression-free Survival

Time frame: Baseline to the end of the study (up to 2 years 10 months). Median (95% Confidence Interval). Unit: Months

Measure	Bevacizumab + Paclitaxel + Gemcitabine n = 90
Value	11.51 (9.01 to 17.59)

Population analysed: Intent-to-treat population: All participants who were enrolled in the study.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bevacizumab + Paclitaxel + Gemcitabine	21 of 82 (25.6%)	82 of 82 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingObservational study
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Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
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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

23 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, Paclitaxel and Gemcitabine in people with Breast Cancer, run by Hoffmann-La Roche at 23 sites in Spain.

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 5 inclusion and 4 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 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Spain. 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?

Yes. Results are posted in the registry (first posted 26 Jun 2014). 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: Baseline to the end of the study (up to 2 years 10 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 NCT00846027.

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 23 Jul 2014.