Breast CancerPhase 2NCT00320541

A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer

A Phase 2 study testing gemcitabine, paclitaxel and bevacizumab in people with Breast Cancer, run by Eli Lilly and Company at 32 sites in 2 countries.

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

This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: gemcitabine, paclitaxel and bevacizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 187 participants
Where: 32 sitesin 2 countries
Study dates: May 2006to Aug 2012
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

Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.
Must be able to measure the disease by specific medical parameters
May have received breast cancer treatment in the early stage of the disease
May be restricted in physically strenuous activity but able to carry out light work.
Must have adequate organ function as seen in blood test results.

Who cannot join

Criteria:
Cancer that has spread to the brain.
Unstable heart problems
Unstable high blood pressure.
Breast cancer treatment after the disease has considered to spread to other areas or organs.
Unable to agree with the requirements of the study

Trial locations and contacts

32 sites in 2 countries.

Country

City, postcode or hospital

32 sites in 2 countries

United States30 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Akron, Ohio, 44302
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Atlanta, Georgia, 30322
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Chesterfield, Missouri, 63017
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Dallas, Texas, 75237
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Dayton, Ohio, 45429
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Denver, Colorado, 80218
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Dunmore, Pennsylvania, 18512
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Everett, Washington, 98201
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Fayetteville, Arkansas, 72703
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Fort Myers, Florida, 33916
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Knoxville, Tennessee, 37916
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La Jolla, California, 92037
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Lexington, Kentucky, 40536
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Lubbock, Texas, 79415
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Madison, Wisconsin, 53717
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Memphis, Tennessee, 38138
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Miami, Florida, 33136
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Miami Beach, Florida, 33140
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Milwaukee, Wisconsin, 53226
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Mission Hills, California, 91345
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Missoula, Montana, 59807
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Muncie, Indiana, 47303
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Nashville, Tennessee, 37203
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Oklahoma City, Oklahoma, 73104
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Orlando, Florida, 32806
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Pittsburgh, Pennsylvania, 15213
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Richmond, Virginia, 23230
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Santa Rosa, California, 95403
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Southfield, Michigan, 48075
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Springfield, Illinois, 62703

Other trials in United States

Puerto Rico2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ponce, 00716
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San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Randomized Phase II Trial of Paclitaxel and Bevacizumab Versus Gemcitabine, Paclitaxel, and Bevacizumab as First Line Treatment for Locally Advanced or Metastatic Breast Cancer

This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer

Conditions: Breast Cancer
Being tested: gemcitabine, paclitaxel, bevacizumab
Keywords: Breast Cancer, Cancer of Breast, Cancer of the breast, Breast Neoplasms
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gemcitabineDrug
Also called LY188011, Gemzar
1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
paclitaxelDrug
Also called Taxol
90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
bevacizumabDrug
Also called Avastin
10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity

Study groups in NCT00320541
Study group	Role	What they receive
paclitaxel plus bevacizumab (PB)	Active comparator	paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days Receives: Drug: paclitaxel; Drug: bevacizumab
paclitaxel plus bevacizumab plus gemcitabine (PB+G)	Experimental	paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days Receives: Drug: gemcitabine; Drug: paclitaxel; Drug: bevacizumab

What is being measured

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

Overall Response Rate (ORR)
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).
Measured: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)

Secondary outcomes (9)

Progression-free Survival (PFS)
PFS was measured from date of randomization to first date of disease progression or death from any cause. For participants not known to have died or had disease progression as of data-inclusion cut-off date, PFS duration was censored at date of last study visit prior to data-inclusion cut-off date.
Measured: baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated)
Overall Survival
Overall survival was measured from date of randomization to date of death from any cause. For participants not known to have died as of data-inclusion cut-off date, overall survival duration was censored at date of last study visit prior to the data cut-off date.
Measured: baseline to death from any cause (up to 35 months)
Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy
FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), \& additional concerns of breast cancer (BCS). Total FACT-B scores range from 0-144, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for FACT-B is 7-8 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Measured: Baseline through 30 days post therapy follow-up (up to 35 months)
Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy
The PWB subscale of FACT-B measures physical well-being. Total PWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Measured: Baseline through 30 days post therapy follow-up (up to 35 months)
Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy
The SFWB subscale of FACT-B measures social/family well-being. Total SFWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Measured: Baseline through 30 days post therapy follow-up (up to 35 months)
Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy
The EWB subscale of FACT-B measures emotional well-being. Total EWB scores range from 0 to 24, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Measured: Baseline through 30 days post therapy follow-up (up to 35 months)
Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy
The FWB subscale of FACT-B measures functional well-being. Total FWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Measured: Baseline through 30 days post therapy follow-up (up to 35 months)
Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy
The BCS subscale of FACT-B measures additional concerns of breast cancer . Total BCS scores range from 0 to 36, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for BCS is 2-3 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Measured: Baseline through 30 days post therapy follow-up (up to 35 months)
Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy
The TOI-B represents the total of the subscales PWB,FWB, and BCS. Total TOI-B scores range from 0 to 92, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for TOI is 5-6 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Measured: Baseline through 30 days post therapy follow-up (up to 35 months)

Timeline

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

May 2006Aug 2012

First posted3 May 2006 (estimated)
Study startMay 2006
Primary completionApr 2009
Study completionAug 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 Eli Lilly and CompanyThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 187 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00320541
Sponsor's protocol ID: 10663
Other IDs: B9E-US-S377
Status last verified: Jul 2013
First submitted: 28 Apr 2006
Last updated: 22 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase II Trial of Paclitaxel and Bevacizumab Versus Gemcitabine, Paclitaxel, and Bevacizumab as First Line Treatment for Locally Advanced or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT00320541
Acronym / sponsor ID: 10663
Conditions: Breast Cancer
Keywords: Breast Cancer, Cancer of Breast, Cancer of the breast, Breast Neoplasms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 187 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Genentech, Inc.
Study start: May 2006
Primary completion: Apr 2009 (actual)
Study completion: Aug 2012 (actual)
First posted: 3 May 2006 (estimated)
Results: Posted 27 Jul 2010

Clinical summary

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

This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
paclitaxel plus bevacizumab (PB)	Active comparator	Drug: paclitaxel, Drug: bevacizumabpaclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel plus bevacizumab plus gemcitabine (PB+G)	Experimental	Drug: gemcitabine, Drug: paclitaxel, Drug: bevacizumabpaclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days

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)

Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.
Must be able to measure the disease by specific medical parameters
May have received breast cancer treatment in the early stage of the disease
May be restricted in physically strenuous activity but able to carry out light work.
Must have adequate organ function as seen in blood test results.

Key exclusion criteria (6 listed)

Cancer that has spread to the brain.
Unstable heart problems
Unstable high blood pressure.
Breast cancer treatment after the disease has considered to spread to other areas or organs.
Unable to agree with the requirements of the study

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
gemcitabineAlso: LY188011, Gemzar1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity	Drug	paclitaxel plus bevacizumab plus gemcitabine (PB+G)
paclitaxelAlso: Taxol90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity	Drug	paclitaxel plus bevacizumab (PB), paclitaxel plus bevacizumab plus gemcitabine (PB+G)
bevacizumabAlso: Avastin10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity	Drug	paclitaxel plus bevacizumab (PB), paclitaxel plus bevacizumab plus gemcitabine (PB+G)

Primary outcome

Overall Response Rate (ORR)
Time frame: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).

9 secondary outcomes

Progression-free Survival (PFS)
Time frame: baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated)
Overall Survival
Time frame: baseline to death from any cause (up to 35 months)
Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy
Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)
Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy
Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)
Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy
Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)
Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy
Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)
Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy
Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)
Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy
Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)
Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy
Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)

Results and safety

Results posted to the registry on 27 Jul 2010, 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 Plus Bevacizumab (PB)	94	44
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)	93	36

Primary outcome: Overall Response Rate (ORR)

Time frame: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months). Mean (95% Confidence Interval). Unit: proportion of responders

Measure	Paclitaxel Plus Bevacizumab (PB) n = 94	Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G) n = 92
Value	0.489 (0.385 to 0.595)	0.587 (0.479 to 0.689)

Paclitaxel Plus Bevacizumab (PB) vs Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G): p = 0.117, Fisher Exact

Population analysed: Per-protocol population included intent-to-treat participants who met the following criteria: histological or cytological breast cancer diagnosis; baseline presence of measurable disease per RECIST; at least 1 dose of study drug; no current systemic anti-tumor therapy except protocol-specified therapy. One PB+G participant did not qualify.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paclitaxel Plus Bevacizumab (PB)	27 of 94 (28.7%)	93 of 94 (98.9%)	Not reported
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)	36 of 93 (38.7%)	93 of 93 (100%)	Not reported

Limitations and caveats (from the sponsor): Of 191 randomized patients, 4 patients were disqualified from inclusion in any efficacy or safety analyses due to significant Good Clinical Practice (GCP) violations; data is reported for the remaining 187 randomized patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

32 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine, paclitaxel and bevacizumab in people with Breast Cancer, run by Eli Lilly and Company at 32 sites in 2 countries.

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 6 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 Jul 2013. 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 United States, Puerto Rico. 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 27 Jul 2010). 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?

Overall Response Rate (ORR) (time frame: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 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 NCT00320541.

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 Jul 2013.