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Metastatic Breast CancerPhase 2NCT00394082

ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer

A Phase 2 study testing ABI-007 and Bevacizumab in people with Metastatic Breast Cancer, run by Celgene at 20 sites in United States.

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

The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in combination with bevacizumab. The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab for patients with previously untreated advanced/metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
ABI-007 and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
20 sitesUnited States
Study dates
1 Jun 2006to 1 Feb 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 (defined as the presence of at least one lesion that can be accurately measured in at least one dimension with longest diameter greater or = 1.0 cm with spiral computed tomography (CT) scan).
  • Patients must not be a candidate for Herceptin therapy (i.e., patients with HER-2 positive disease (gene amplification by fluorescence in situ hybridization (FISH) or 3 + overexpression by ICH) and patients with unknown HER-2 status are ineligible unless the treating physicians has determined that Herceptin-based therapy would be inappropriate or not indicated).
  • For subjects with prior anthracycline exposure, normal cardiac function including a baseline left ventricle ejection fraction >50% or above institution's lower limit of normal and a normal electrocardiogram (ECG) (as assessed by the investigator).
  • At least 2 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.
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  • International Normalized Ratio (INR) < 1.5 and activated partial thromboplastin time within normal limits (APTT WNL).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Female > 18 years of age.
  • Patients have the following blood counts at Baseline: absolute neutrophil count (ANC) greater or equal to 1.5 x 10^9 cells/L; platelets greater or equal 100 x 10^9 cells/L; hemoglobin (Hgb) greater or equal to 9g/dL.
  • Patients have the following blood chemistry levels at Baseline: aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT) less than or equal 2.5x upper limit of normal (ULN) range (less than or equal 5x ULN if patient has known liver metastases); total bilirubin greater than or equal to ULN; creatinine greater or equal to 1.5mg/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

  • No prior chemotherapy for metastatic or locally recurrent disease is allowed.
  • Prio neo-adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies.
  • if a taxane was part of the adjuvant regimen, at least 12 months must have elapsed between the last dose of the taxane and the date of diagnosis of metastatic disease.
  • if a non-taxane-based adjuvant therapy was administered, at least six months must have elapsed between the last dose of the non- taxane-containing chemotherapy and the date of diagnosis of metastatic disease.
  • Concurrent immunotherapy or hormonal therapy.
  • Parenchymal brain metastases, including leptomeningeal involvement.
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  • Uncontrolled hypertension (defined as blood pressure of > 150/100 mmHg)
  • NYHA Grade 2 or greater congestive heart failure
  • History of coagulopathy, bleeding diathesis, therapeutic anticoagulation other than low dose or chronic ASA greater than or equal to 325 mg per day. Low dose coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH)for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.
  • Urine protein:creatinine ratio less than or equal to 1.0 at screening.
  • No history of cerebrovascular accident within six months of study entry.
  • Active symptomatic peripheral vascular disease (e.g. aortic aneurysm, claudication) within six months of study entry.
  • Uncontrolled or severe cardiovascular disease including myocardial infarction or unstable angina within six months of study entry.
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal process within six months of study entry.
  • No serious non-healing wound, ulcer, or bone fracture
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose, or anticipation of need for major surgical procedure during the course of the study. No minor surgical procedure within seven days of study entry. 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.
  • Patients with current sensory neuropathy of > Grade 1 will be excluded.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Study site

    Bedford, Texas, 76022

  • Study site

    Burien, Washington, 98166

  • Study site

    Columbia, Maryland, 21044

  • Study site

    Dallas, Texas, 75246

  • Study site

    Edmonds, Washington, 98026

  • Study site

    El Paso, Texas, 79915

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Niles, Illinois, 60714

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Ocoee, Florida, 34761

  • Study site

    Odessa, Texas, 79761

  • Study site

    Rochester, New York, 14623

  • Study site

    Saint Joseph, Missouri, 64507

  • Study site

    Salem, Virginia, 24153

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Terre Haute, Indiana, 47802

  • Study site

    Tyler, Texas, 75702

  • Study site

    Vancouver, Washington, 98684

  • Study site

    Westminister, Maryland, 21157

Other trials in United States

About this study

Official title: A Phase II Trial of Weekly Administration of ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer

The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in combination with bevacizumab.

The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab for patients with previously untreated advanced/metastatic breast cancer.

Being tested
ABI-007, Bevacizumab
Keywords
Metastatic breast cancer, Abraxane, 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.

  • ABI-007Drug

    Also called Abraxane®, Nab-paclitaxel

    125 mg/m^2 of ABI-007 administered by intravenously (IV) over 30 minutes on days 1, 8 and 15 of each 28 day cycle.

  • BevacizumabDrug

    Also called NSC 704865, RhuMAb VEGF, Recombinant Humanized Monoclonal Bevacizumab Antibody

    Bevacizumab administered once every 2 weeks (10 mg/kg) by IV infusion after ABI-007 has been given. The first dose is one Day 1, cycle 1.

Study groups in NCT00394082
Study groupRoleWhat they receive
ABI-007 plus BevacizumabExperimentalABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
Receives: Drug: ABI-007; Drug: Bevacizumab

What is being measured

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

  1. Participants With At Least One Treatment-Emergent Adverse Event (TEAE)

    Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.

    Measured: up to 25 months

  2. Kaplan-Meier Estimates for Progression-free Survival

    Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first. Patients who do not have disease progression or have not died at the end of follow-up were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.

    Response Evaluation Criteria in Solid Tumors (RECIST) defines progressive disease (PD) as a >= 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.

    Measured: up to 39 months

Secondary outcomes (4)

  1. Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)

    Objective response is complete response (CR) + partial response (PR). RECIST defines overall response of CR as the disappearance of all target and non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. Overall response of PR is defined as >= 30% decrease from baseline in the sum of the longest diameters of target lesions and no progression of non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing and no appearance of new lesions. The objective response is determined by combining the response of target and non-target lesions and the appearance of new lesion(s) or not together.

    Measured: up to 39 months

  2. Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST)

    Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). RECIST defines SD as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease and no new lesions. Definitions for CR and PR can be found in outcome #3.

    Measured: up to 39 months

  3. Kaplan-Meier Estimate for Duration of Response

    Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.

    Progressive disease is defined in outcome #2. Complete response (CR) and partial response (PR) are defined in outcome #3.

    Measured: up to 39 months

  4. Kaplan-Meier Estimates for Participant Survival

    Participant survival is the time from the first dose of study drug to patient death from any cause. Patients that did not die were censored at the last known time the patient was alive.

    Measured: up to 39 months

Timeline

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

  1. First posted31 Oct 2006 (estimated)
  2. Study start1 Jun 2006
  3. Primary completion1 Sep 2009
  4. Study completion1 Feb 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00394082
Sponsor's protocol ID
CA043
Status last verified
Nov 2019
First submitted
30 Oct 2006
Last updated
25 Nov 2019
Data monitoring committee
No

Publications

  • Danso M, et al. Phase II trial of weekly nab-paclitaxel in combination with bevacizumab as first-line treatment in metastatic breast cancer. Presented at 2008 ASCO Annual Meeting, May 30-June 3, 2008, Chicago, IL. Abstract No. 1075.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABI-007 and Bevacizumab in people with Metastatic Breast Cancer, run by Celgene at 20 sites in United States.

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 20 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 25 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 20 sites in United States. 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 22 May 2013). 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?

Participants With At Least One Treatment-Emergent Adverse Event (TEAE) (time frame: up to 25 months). The study lists 2 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 NCT00394082, which also lists 1 linked publication.

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 25 Nov 2019.

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