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Breast CancerPhase 2NCT00607438

A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer

A Phase 2 study testing Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane) and Sorafenib (Nexavar) in people with Breast Cancer, run by Veeda Oncology at 1 site in United States.

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 Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer. Each cycle will be 4 weeks in length. Patients will receive Abraxane weekly for 3 weeks. Patients will not receive Abraxane during week 4 (rest week). Nexavar will be given continuously. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane) and Sorafenib (Nexavar)
How many people
16 participants
Where
1 siteUnited States
Study dates
Sep 2007to May 2009
Phase
Phase 2
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have signed an IRB-approved informed consent.
  • Patients must have histologically confirmed locally advanced or metastatic breast cancer.
  • Patients must be HER2-negative.
  • Patients must have measurable disease, as defined by the RECIST criteria.
  • Patients may have received prior adjuvant chemotherapy for breast cancer, including taxane-containing regimens, provided this treatment was completed at least 12 months prior to enrollment.
  • Patients must be <18 years of age.
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  • Patients must have an ECOG Performance Status of 0 or 1.
  • Patients' estimated life expectancy must be at least 12 weeks.
  • Patients must have adequate liver functions defined as: total bilirubin within normal limits and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN) (or < 5 X ULN for patients with liver involvement).
  • Patients must have alkaline phosphatase ≤ 2.5 X ULN. Alkaline phosphatase may be > 2.5 x ULN if bone metastasis is present in the absence of liver metastasis, and the patient's bilirubin ≤ ULN.
  • Patients must have adequate renal function defined as: creatinine ≤ 1.5 mg/dL.
  • Patients must have adequate bone marrow function, including absolute neutrophil count (ANC) >1500/µL, platelet count >100,000/µL, and hemoglobin >9 g/dL.
  • Patients must have a normal baseline left ventricular ejection fraction (LVEF).
  • Patients must be normotensive. Patients taking anti-hypertensive medication must have blood pressure controlled and not greater than 140/90.
  • International Normalized Ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits.
  • Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
  • Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
  • Patients must be willing and able to comply with scheduled visits, treatment plan and laboratory testing, and be accessible for follow-up.

Who cannot join

  • Patients who have received prior chemotherapy for the treatment of locally advanced or metastatic breast cancer.
  • Patients who have received prior Abraxane or Nexavar.
  • Patients who have a history of hypersensitivity or a suspected allergy to taxanes, any of the components in taxanes, Abraxane, or Nexavar.
  • Patients with serious intercurrent medical or psychiatric illness, including serious active infection.
  • Patients with untreated or active brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
  • Patients with a history of thrombosis.
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  • Patients with thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Patients with symptomatic congestive heart failure or a baseline echocardiogram with LVEF < ULN.
  • Patients with congestive heart failure > class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest), or new onset angina (began within the last 3 months), or myocardial infarction within the past 6 months.
  • Patients with cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Patients with a history of, or active, bowel perforation or inflammatory bowel disease.
  • Patients with active peptic ulcer disease or symptoms to suggest possible ulcer (discontinuation of chronic NSAID therapy advised, or if not possible, use of proton-pump inhibitors recommended.)
  • Patients planning to receive any concurrent therapy to treat locally advanced or metastatic breast cancer during the study treatment period.
  • Any patient who is pregnant or lactating.
  • Patients with proteinuria > +1 by baseline dipstick, or if +2, 24-hour urine total protein > 250 mg.
  • Patients who have undergone major surgery, open biopsy, or significant traumatic injury within 28 days, or minor surgery within 14 days. (The placement of a Mediport or other vascular access device is permitted if performed at least 7 days prior to registration).
  • Patients with > Grade 2 peripheral neuropathy (NCI-CTC v3.0) or any painful neuropathy.
  • Patients who have experienced any type of bone fracture within 12 months or who have undergone joint replacement surgery within 6 months.
  • Patients with a serious non-healing wound.
  • Patients with known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  • Patients requiring anticoagulants (with the exception of low-dose Coumadin, ASA, Plavix or Heparin for maintenance of vascular access patency).
  • Patients with evidence or history of bleeding diathesis or coagulopathy.
  • Patients experiencing any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
  • Patients with pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
  • Patients with any condition that impairs a patient's ability to swallow whole pills or patients with any malabsorption problems.
  • Patients who use St. John's Wort or rifampin (rifampicin).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Veeda Oncology

    Columbus, Ohio, 43215

Other trials in United States

About this study

This is a Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer.

Each cycle will be 4 weeks in length. Patients will receive Abraxane weekly for 3 weeks. Patients will not receive Abraxane during week 4 (rest week). Nexavar will be given continuously.

Patients will be radiologically evaluated every 8 weeks for response. Patients will continue to receive study treatment until disease progression or unacceptable toxicity.

Conditions
Breast Cancer
Being tested
Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane), Sorafenib (Nexavar)
Keywords
Locally Advanced or Metastatic
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.

  • Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane)Drug

    Also called Abraxane

    125 mg/m2 Paclitaxel by 30-minute IV infusion weekly for 3 weeks.

  • Sorafenib (Nexavar)Drug

    Also called Nexavar

    400 mg orally twice a day continuously (even during rest week) starting on Day 1.

What is being measured

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

  1. To evaluate the progression-free survival (PFS)and duration of response of the combination of weekly Abraxane and continuous Nexavar as first-line treatment for patients with locally advanced or metastatic breast cancer.

    Measured: Survival every 3 months for two years starting from the end of study date. Duration of response every 8 weeks while on treatment.

Secondary outcomes (3)

  1. To evaluate the response rate.

    Measured: Every 8 weeks while on study treatment.

  2. Evaluate the 1 and 2 year survival rate.

    Measured: Every 3 months for 2 years starting from the end of therapy visit date

  3. Evaluate the toxicities of the combination of Abraxane and Nexavar

    Measured: At each clinic visit or if reported by subject.

Timeline

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

  1. First posted5 Feb 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionMay 2009
  4. Study completionMay 2009

Why it stopped: Low accrual

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00607438
Sponsor's protocol ID
I-06-025
Status last verified
May 2012
First submitted
22 Jan 2008
Last updated
11 May 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane) and Sorafenib (Nexavar) in people with Breast Cancer, run by Veeda Oncology at 1 site 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 18 inclusion and 26 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 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was stopped early (reason given: Low accrual). Results are not available in the source record.

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?

To evaluate the progression-free survival (PFS)and duration of response of the combination of weekly Abraxane and continuous Nexavar as first-line treatment for patients with locally advanced or metastatic breast cancer. (time frame: Survival every 3 months for two years starting from the end of study date. Duration of response every 8 weeks while on treatment.). 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 NCT00607438.

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 11 May 2012.

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