NCT00320541

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started May 2006

Typical duration for phase_2 breast-cancer

Geographic Reach
2 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2006

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 27, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 22, 2013

Status Verified

July 1, 2013

Enrollment Period

2.9 years

First QC Date

April 28, 2006

Results QC Date

April 26, 2010

Last Update Submit

July 15, 2013

Conditions

Breast Cancer

Keywords

Breast CancerCancer of BreastCancer of the breastBreast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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).

    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)

    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

    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

    Baseline through 30 days post therapy follow-up (up to 35 months)

  • Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy

    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

    Baseline through 30 days post therapy follow-up (up to 35 months)

  • +4 more secondary outcomes

Study Arms (2)

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

Drug: paclitaxelDrug: 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

Drug: gemcitabineDrug: paclitaxelDrug: bevacizumab

Interventions

gemcitabineDRUG

1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity

Also known as: LY188011, Gemzar
paclitaxel plus bevacizumab plus gemcitabine (PB+G)
paclitaxelDRUG

90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity

Also known as: Taxol
paclitaxel plus bevacizumab (PB)paclitaxel plus bevacizumab plus gemcitabine (PB+G)
bevacizumabDRUG

10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity

Also known as: Avastin
paclitaxel plus bevacizumab (PB)paclitaxel plus bevacizumab plus gemcitabine (PB+G)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

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.

Fayetteville, Arkansas, 72703, United States

Location

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.

La Jolla, California, 92037, United States

Location

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.

Mission Hills, California, 91345, United States

Location

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.

Santa Rosa, California, 95403, United States

Location

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.

Denver, Colorado, 80218, United States

Location

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.

Fort Myers, Florida, 33916, United States

Location

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.

Miami, Florida, 33136, United States

Location

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.

Miami Beach, Florida, 33140, United States

Location

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.

Orlando, Florida, 32806, United States

Location

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.

Atlanta, Georgia, 30322, United States

Location

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.

Springfield, Illinois, 62703, United States

Location

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.

Muncie, Indiana, 47303, United States

Location

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.

Lexington, Kentucky, 40536, United States

Location

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.

Southfield, Michigan, 48075, United States

Location

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.

Chesterfield, Missouri, 63017, United States

Location

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.

Missoula, Montana, 59807, United States

Location

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, United States

Location

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.

Dayton, Ohio, 45429, United States

Location

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.

Oklahoma City, Oklahoma, 73104, United States

Location

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.

Dunmore, Pennsylvania, 18512, United States

Location

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.

Pittsburgh, Pennsylvania, 15213, United States

Location

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.

Knoxville, Tennessee, 37916, United States

Location

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.

Memphis, Tennessee, 38138, United States

Location

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.

Nashville, Tennessee, 37203, United States

Location

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.

Dallas, Texas, 75237, United States

Location

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.

Lubbock, Texas, 79415, United States

Location

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.

Richmond, Virginia, 23230, United States

Location

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.

Everett, Washington, 98201, United States

Location

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.

Madison, Wisconsin, 53717, United States

Location

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.

Milwaukee, Wisconsin, 53226, United States

Location

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, Puerto Rico

Location

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.

San Juan, 00935, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

GemcitabinePaclitaxelBevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

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.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2006

First Posted

May 3, 2006

Study Start

May 1, 2006

Primary Completion

April 1, 2009

Study Completion

August 1, 2012

Last Updated

July 22, 2013

Results First Posted

July 27, 2010

Record last verified: 2013-07

Locations

US(30)PR(2)