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Recurrent Breast CancerPhase 1/2NCT00217399

Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

A Phase 1/2 study testing sorafenib tosylate and anastrozole in people with Recurrent Breast Cancer and Stage IV Breast Cancer, run by National Cancer Institute (NCI) at 1 site 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

Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Estradiol can cause the growth of breast cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estradiol by the tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
sorafenib tosylate and anastrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Jun 2005to Jan 2013
Phase
Phase 1/2
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

  • Histologically or cytologically confirmed breast cancer
  • Metastatic disease
  • Measurable disease, defined as >=1 unidimensionally measurable lesion, including >= 1 of the following:
  • Lesion >= 10 mm on CT scan (5 mm sections)
  • Lesion >= 20 mm on CT scan or MRI (10 mm sections)
  • Bone disease that is >= 10 mm on MRI
Show all 49Show fewer
  • Lytic bone lesions that are >= 10 mm on CT scan (with 5 mm sections) OR >= 20 mm on plain film or CT scan (with 10 mm sections)
  • Lesion >= 10 mm on physical exam
  • Patients must have received >= 1 prior aromatase inhibitor in either the adjuvant or metastatic setting and must have had either disease recurrence or disease progression on a prior aromatase inhibitor therapy
  • No brain metastases diagnosed within the past 6 months OR previously untreated brain metastases
  • Estrogen receptor-positive and/or progesterone receptor-positive, defined as > 1% staining by immunohistochemistry or > 10 fmol/mg of protein by radio-ligand dextran-coated steroid binding assay
  • Postmenopausal, as defined by 1 of the following:
  • Prior bilateral oophorectomy
  • No menses for >= 12 months in patients with an intact uterus
  • Follicle-stimulating hormone (FSH) in postmenopausal range in patients < 60 years of age who have had a prior hysterectomy or have been amenorrheic for >= 3 months
  • Age >= 60 years
  • Pre- or perimenopausal patients receiving monthly injections of goserelin at a dose of 3.6 mg are eligible
  • ECOG 0-2
  • More than 3 months
  • Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 No bleeding diathesis
  • Bilirubin =< 1.5 times upper limit of normal (ULN AST and ALT =< 2.5 times ULN
  • Systolic blood pressure (BP) < 150 mm Hg and diastolic BP < 100 mm Hg on at least one reading prior to study entry No uncontrolled hypertension
  • None of the following within the past 6 months:
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Myocardial infarction
  • Cardiac arrhythmia with hemodynamic compromise
  • Not pregnant or nursing
  • Able to swallow oral medication
  • No known HIV positivity
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other active invasive malignancy within the past 5 years except nonmelanoma skin cancer or treated carcinoma in situ of the cervix
  • No other uncontrolled illness
  • More than 4 weeks since prior chemotherapy
  • No more than 2 prior chemotherapy regimens for metastatic disease
  • At least 8 weeks since prior anastrozole therapy
  • Concurrent steroids allowed if dose is stable
  • More than 4 weeks since prior radiotherapy
  • More than 4 weeks since prior major surgery
  • Recovered from prior therapy
  • No prior sorafenib
  • No concurrent therapeutic anticoagulation
  • Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed provided PT and PTT are =< 1.5 times ULN
  • No concurrent agents that may interact with sorafenib, including any of the following:
  • Hypericum perforatum (St. John's wort)
  • Rifampin
  • P450 CYP3A4 enzyme-inducing anticonvulsants (e.g., phenytoin, carbamazepine, or phenobarbital)
  • No other concurrent investigational agents

Who cannot join

  • estrogen receptor status unknown
  • history of myocardial infarction within 6 months
  • performance status 3
  • performance status 4
  • premenopausal
  • progesterone receptor status unknown
  • HIV positive

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lombardi Comprehensive Cancer Center at Georgetown University

    Washington D.C., District of Columbia, 20057

Other trials in United States

About this study

Official title: A Phase I/II Trial of BAY 43-9006 (Sorafenib) in Combination With Anastrozole in Patients With Metastatic Breast Cancer

Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Estradiol can cause the growth of breast cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estradiol by the tumor cells. Sometimes when hormone therapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to hormone therapy. Giving sorafenib together with anastrozole may reduce drug resistance and allow the tumor cells to be killed. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with anastrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the clinical benefit rate of sorafenib in combination with anastrazole in women with estrogen receptor- and/or progesterone receptor-positive metastatic breast cancer.

II. Determine the recommended phase II dose of sorafenib when administered with anastrozole in these patients.

SECONDARY OBJECTIVES:

  1. Determine the toxic effects of this regimen in these patients. II. Determine the changes in Raf-MAPK and VEGF-signaling pathways in tumor tissue and stroma before and after treatment with this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of sorafenib.

PHASE I: Patients receive oral sorafenib twice daily and oral anastrozole once daily on days 1-28.

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD.

PHASE II: Patients receive sorafenib at the MTD and anastrozole as in phase I.

After completion of study treatment, patients are followed every 4-8 weeks.

Being tested
sorafenib tosylate, anastrozole
Medical subject headings
Breast Neoplasms

What participants receive

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

  • sorafenib tosylateDrug

    Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar

    Given orally

  • anastrozoleDrug

    Also called ANAS, Arimidex, ICI-D1033

    Given orally

Study groups in NCT00217399
Study groupRoleWhat they receive
TreatmentExperimentalPHASE I: Patients receive oral sorafenib twice daily and oral anastrozole once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD. PHASE II: Patients receive sorafenib at the MTD and anastrozole as in phase I.
Receives: Drug: sorafenib tosylate; Drug: anastrozole

What is being measured

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

  1. Complete Response + Partial Response + Stable Disease > 24 Weeks

    Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking.

    A patient has clinical benefit from treatment if CR + PR + SD > 24 weeks.

    Measured: 24 weeks

Secondary outcomes (2)

  1. Number of Participants With Adverse Events

    Number of patients treated with the sorafenib / anastrozole combination who experienced Grade 1-4 adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0

    Measured: 1 year

  2. Tumor Marker Analysis

    Number of participants with significant change in the following circulating tumor biomarkers, measured by flow cytometry: cluster designation (CD)146, CD133. Values were normalized by CD45 values(ie CD146+/CD45- and CD133+/CD45-).

    Measured: 1 year

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionJul 2009
  4. Study completionJan 2013

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00217399
Sponsor's protocol ID
NCI-2009-00069
Other IDs
NCI-2009-00069, CDR0000440067, 2004-251, 2004-251, 6584
Status last verified
Dec 2012
First submitted
20 Sep 2005
Last updated
28 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing sorafenib tosylate and anastrozole in people with Recurrent Breast Cancer and Stage IV Breast Cancer, run by National Cancer Institute (NCI) 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 49 inclusion and 7 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 28 May 2014. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 12 Feb 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?

Complete Response + Partial Response + Stable Disease > 24 Weeks (time frame: 24 weeks). 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 NCT00217399.

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 28 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.

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