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Breast NeoplasmsPhase 2NCT00281528

Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer

A Phase 2 study testing ABI-007 (Abraxane) and bevacizumab in people with Breast Neoplasms and Neoplasm Metastasis, run by Celgene at 40 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms, Neoplasm Metastasis
What is being tested?
ABI-007 (Abraxane) and bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
40 sitesin 2 countries
Study dates
1 Feb 2006to 1 Mar 2011
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

  • Pathologically confirmed adenocarcinoma of the breast.
  • Stage IV disease
  • Measurable disease
  • Patients must not be a candidate for Herceptin therapy
  • At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease within the radiation portal.
  • At least 4 weeks since major surgery, with full recovery.
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  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Female >18 years of age.
  • Patient has the following blood counts at Baseline:
  • Absolute neutrophil count ≥ 1.5 x 10^9cells/L; platelets ≥ 100 x 10^9 cells/L; hemoglobin ≥ 9 g/dL.
  • Patient has the following blood chemistry levels at Baseline: Aspartate transaminase (AST or SGOT), alanine aminotransferase (ALT or SGPT) ≤ 2.5x upper limit of normal range (ULN); total bilirubin ≤ ULN; creatinine ≤ 1.5 mg/dL.
  • If female of childbearing potential, pregnancy test is negative within 72 hours of first dose of study drug.
  • If fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
  • Informed consent has been obtained.

Who cannot join

  • Prior neo-adjuvant or adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies. No prior therapy for metastatic disease is allowed. If a taxane was part of the adjuvant regimen, at least 12 months should have passed from completion of taxane regimen to relapse. If a non-taxane-based adjuvant therapy was administered, at least 6 months should have passed from completion to relapse.
  • Concurrent immunotherapy or hormonal therapy.
  • Parenchymal brain metastases, including leptomeningeal involvement.
  • Inadequately controlled hypertension (defined as blood pressure of > 150/100 mmHg) or New York Heart Association (NYHA) Grade 2 or greater congestive heart failure.
  • Any prior history of hypertensive crisis or hypertensive encephalopathy.
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment.
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  • History of stroke or transient ischemic attack within 6 months prior to study enrollment.
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection).
  • Symptomatic peripheral vascular disease.
  • Evidence of bleeding diathesis or coagulopathy.
  • History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to study enrollment.
  • Proteinuria at screening as demonstrated by either: - Urine protein:creatinine (UPC) ratio > 1.0 at screening OR - Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
  • Known hypersensitivity to any component of bevacizumab.
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to first dose.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose, anticipation of need for major surgical procedure during the course of the study. Serious, non-healing wound, ulcer, or bone fracture. Serious intercurrent medical or psychiatric illness, including serious active infection.
  • History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
  • Pregnant or nursing women.
  • Sensory neuropathy of > Grade 1 at baseline.

Trial locations and contacts

40 sites in 2 countries.

40 sites in 2 countries

United States39 sites

  • Peachtree Hematology & Oncology Associates

    Atlanta, Georgia

  • TX Oncology, PA

    Austin, Texas

  • Greater Baltimore Medical Center

    Baltimore, Maryland

  • Harbor View Cancer Center

    Baltimore, Maryland

  • Division of Hematology/Oncology University of Alabama at Birmingham

    Birmingham, Alabama

  • Boston Medical Center Moakley Building, Solomont Center for Hematology & Medical Oncology

    Boston, Massachusetts

  • Palm Beach Institute of Hematology and Oncology

    Boynton Beach, Florida

  • Oncology Associates of Bridgeport

    Bridgeport, Connecticut, 06610

  • Rosewell Park Cancer Institute Elm & Carlton Carlton Building

    Buffalo, New York

  • Medical Oncology Aultman Hospital

    Canton, Ohio

  • Family Cancer Center

    Collierville, Tennessee

  • Drs. Forte, Schleidere, & Attas, PA

    Englewood, New Jersey

  • Front Range Cancer Specialists

    Fort Collins, Colorado

  • California Oncology of the Central Valley

    Fresno, California

  • Glendale Memorial Hospital & Health Center

    Glendale, California

  • Memorial Cancer Institute/Breast Cancer Center

    Hollywood, Florida, 33021

  • Florida Cancer Institute

    Hudson, Florida

  • Tennessee Cancer Specialists

    Knoxville, Tennessee

  • Hematology Oncology Associates

    Lake Worth, Florida

  • Medical Specialist of the Palm Beaches, Inc

    Lake Worth, Florida

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma

  • Little Rock Hematology Oncology Associates

    Little Rock, Arkansas

  • Saint Barnabas Medical Center

    Livingston, New Jersey

  • Monmouth Medical Center

    Long Branch, New Jersey

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia

  • Beth Israel Comprehensive Cancer Center

    New York, New York

  • Memorial Sloan Kettering Cancer Center

    New York, New York

  • NYU Clinical Cancer Center

    New York, New York

  • Nebraska Methodist Hospital

    Omaha, Nebraska

  • North Shore Medical Cancer Center

    Peabody, Massachusetts, 01960

  • Virginia Commonwealth University Medical Oncology

    Richmond, Virginia

  • South Texas Oncology & Hematology Clinical Research Dept.

    San Antonio, Texas

  • Maine Center for Cancer Medicine & Blood Disorders

    Scarborough, Maine

  • Swedish Cancer Institute

    Seattle, Washington

  • St. John's Mercy Medical Center

    St Louis, Missouri

  • Gulfcoast Oncology Associates

    St. Petersburg, Florida

  • Center of Hope for Cancers and Blood

    Stockbridge, Georgia, 30281

  • Marion L. Shepard Cancer Center

    Washington, North Carolina

  • Abington Hematology Oncology

    Willow Grove, Pennsylvania

Other trials in United States

Puerto Rico1 site

  • Metropolitan Oncology Center

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase II Study of Weekly Versus Every 2-week Versus Every 3-week Administration of ABI-007 (Abraxane) in Combination With Bevacizumab in Women With Metastatic Breast Cancer.

This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.

Being tested
ABI-007 (Abraxane), bevacizumab
Keywords
First Line Metastatic Breast Cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • ABI-007 (Abraxane)Drug

    Also called Abraxane, paclitaxel bound to albumin

    30 minute infusions

  • bevacizumabDrug

    Also called Avastin

    infusions

Study groups in NCT00281528
Study groupRoleWhat they receive
260 mg/m^2 ABI-007 every 3 weeksExperimental260 mg/m^2 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks
Receives: Drug: ABI-007 (Abraxane); Drug: bevacizumab
260 mg/m^2 ABI-007 every 2 weeksExperimental260 mg/m^2 ABI-007 every 2 weeks and 10 mg/kg bevacizumab every 2 weeks
Receives: Drug: ABI-007 (Abraxane); Drug: bevacizumab
130 mg/m^2 ABI-007 weeklyExperimental130 mg/m^2 ABI-007 weekly (without a week of 'rest') and 10 mg/kg bevacizumab every 2 weeks
Receives: Drug: ABI-007 (Abraxane); Drug: bevacizumab

What is being measured

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

  1. The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)

    Using the RECIST response criteria version 1.0, the percent of participants achieving either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.

    Measured: Up to 43 months

  2. Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)

    Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) ANC counts were graded using NCI CTCAE version 3:

    Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9L; Grade 2 = <1.5 - 1.0*10^9L; Grade 3 = <1.0 - 0.5*10^9L; Grade 4 = <0.5*10^9L

    Measured: up to 54 months

  3. Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)

    Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) WBC counts were graded using NCI CTCAE version 3:

    Grade 0 = within normal limits; Grade 1 = < lower limit of normal -3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 - 1.0*10^9/L; Grade 4 = <1.0*10^9/L

    Measured: up to 54 months

  4. Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)

    Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) platelet counts were graded using NCI CTCAE version 3:

    Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 - 25.0*10^9/L; Grade 4 = <25.0*10^9/L

    Measured: up to 54 months

  5. Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)

    Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) hemoglobin levels were graded using NCI CTCAE version 3:

    Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 100g/L; Grade 2 = <100 - 80g/L; Grade 3 = <80 - 65g/L; Grade 4 = <65g/L

    Measured: up to 54 months

  6. The Number of Participants With at Least One Dose Reduction for ABI-007

    Participants with at least one dose reduction for ABI-007. ABI-007 (Abraxane) dose could be reduced according to protocol guidelines if the participant was experiencing toxicities. Participants were allowed two ABI-007 (Abraxane) dose reductions during the course of the trial. This outcome is considered to be both a safety and an efficacy outcome.

    Measured: Up to 53 months

  7. The Number of Participants With at Least One Dose Delay for ABI-007

    Participants with at least one dose delay for ABI-007. Treatment delays of no longer than 2 weeks allowed participants to recovery from acute toxicity. If treatment was delayed beyond 2 weeks, continuing treatment on protocol was at the physician's discretion, based upon the best interests of the participant. This outcome is considered to be both a safety and an efficacy outcome.

    Measured: Up to 53 months

  8. The Number of Participants With a Dose Interruption of ABI-007

    Number of participants who interrupted (omitted) a dose at some point in the treatment period. This outcome is considered to be both a safety and an efficacy outcome.

    Measured: Up to 53 months

Secondary outcomes (5)

  1. Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response (i.e., Total Response) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)

    Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), the percentage of participants achieving either

    • A complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or
    • A partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions or
    • Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for progressive disease.

    Measured: Up to 43 months (until progressed)

  2. Kaplan Meier Estimate for Time to Disease Progression (TTP)

    Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.

    Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.

    Measured: Up to 43 months (until progressed)

  3. Kaplan Meier Estimate for Duration of Response

    Duration of response was defined as the time from response to the time of disease progression for participants who achieve an objective confirmed complete (CR) or partial overall response (PR). Disease progression is based on the assessments by the investigator. Participants who did not have disease progression following a confirmed complete or partial target response were censored at the last known time that the participant was evaluated for response

    Measured: Up to 43 months (until progressed)

  4. Kaplan Meier Estimate for Participant Survival

    Participant survival was summarized using Kaplan-Meier estimate of the time of first dose of study drug to the last known time that the participant was alive. Participants that were alive at the end of follow-up would be censored at the last known time that the patient was alive.

    Measured: Up to 56 months

  5. Kaplan Meier Estimate for Progression-Free Survival (PFS)

    PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.

    Measured: up to 56 months

Timeline

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

  1. First posted25 Jan 2006 (estimated)
  2. Study start1 Feb 2006
  3. Primary completion1 Jul 2010
  4. Study completion1 Mar 2011

Why it stopped: sufficient mature data to complete a final analysis

Resources

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
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281528
Sponsor's protocol ID
CA023
Status last verified
Nov 2019
First submitted
24 Jan 2006
Last updated
22 Nov 2019
Data monitoring committee
No

Publications

  • Seidman AD, Conlin AK, Bach A, Moynahan ME, Lake D, Forero A, Wright GS, Hackney MH, Clawson A, Norton L, Hudis CA. Randomized phase II trial of weekly vs. every 2 weeks vs. every 3 weeks nanoparticle albumin-bound paclitaxel with bevacizumab as first-line chemotherapy for metastatic breast cancer. Clin Breast Cancer. 2013 Aug;13(4):239-246.e1. doi: 10.1016/j.clbc.2013.02.008.

    PubMed 23829890

  • Conlin AK, Seidman AD, Bach A, Lake D, Dickler M, D'Andrea G, Traina T, Danso M, Brufsky AM, Saleh M, Clawson A, Hudis CA. Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2010 Aug 1;10(4):281-7. doi: 10.3816/CBC.2010.n.036.

    PubMed 20705560

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABI-007 (Abraxane) and bevacizumab in people with Breast Neoplasms and Neoplasm Metastasis, run by Celgene at 40 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 14 inclusion and 19 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: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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 13 Mar 2012). 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?

The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0) (time frame: Up to 43 months). The study lists 8 primary outcomes in all. 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 NCT00281528, which also lists 2 linked publications.

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 Nov 2019.

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