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AzTrials

Male Breast CancerPhase 2NCT00244881

A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202)

A Phase 2 study testing cediranib maleate and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent 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

AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well AZD2171 works in treating patients with refractory stage IV breast cancer Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cediranib maleate and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
Sep 2005to Dec 2007
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed Breast Cancer, stage IV, including:
  • "Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Breast cancer stage IV","10006202"
  • Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Breast cancer recurrent","10006198"
  • "Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Inflammatory carcinoma of breast stage IV","10021979"
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
  • Patients must have refractory breast cancer, defined as overt clinical tumor progression on most recent treatment with either hormonal therapy, chemotherapy, and/or trastuzumab therapy; patients with up to 3 prior chemotherapy regimens and with any number of biological (hormonal, trastuzumab) regimens for metastatic breast cancer will be eligible
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  • Life expectancy of greater than 3 months as assessed by the patient's primary oncologist
  • Absolute neutrophil count > 1,500/mcL
  • Platelets > 100,000/mcL
  • Hemoglobin >= 8 g/dL
  • Prothrombin time < institutional upper limit of normal (ULN)
  • Total bilirubin =< 1.5 x ULN
  • AST(SGOT)/ALT(SGPT) =< 2.5 × ULN
  • Creatinine within normal institutional limits
  • Urinalysis with < 1+ proteinuria
  • Troponin T or I within normal institutional limits
  • LVEF >= 45%, as assessed by echocardiogram or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment
  • At present, the potential of AZD2171 for clinically significant drug interactions involving the CYP isozymes is unknown; however, studies of the agent in rats indicated possible suppression of CYP1A that may be of biological significance; eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of AZD2171 will be determined following review of their case by the Principal Investigator.
  • AZD2171 has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • No therapeutic anti-coagulation; the use of low dose warfarin (1-2 mg/day), intermittent doses of TPA (2 mg x 1), or heparin flushes to prophylax against central venous catheter-associated clots is acceptable
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days
  • Patients may not have been previously treated with an anti-angiogenesis agent
  • \Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine); these medications will also not be permitted after the start of the study
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; a head CT or MRI must be performed at baseline
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171
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  • Any contraindications/barrier to oral medication
  • EKG abnormalities of known clinical significance, such as prolonged QT (mean QTc > 470 msec, with Bazett's correction, in screening electrocardiogram or history of familial long QT syndrome); an EKG is required for study entry
  • Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because AZD2171 is a VEGF inhibitor with known abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD2171, breastfeeding should be discontinued if the mother is treated with AZD2171
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
  • Patients at increased risk for compromised LVEF requiring concurrent use of drugs or biologics with proarrythmic potential; these drugs are prohibited during studies with AZD2171 (refer to Appendix J for a listing of these agents)
  • Patients with a New York Heart Association classification of III or IV are excluded (NOTE: patients classified as class II are eligible if controlled on medication and stable with increased monitoring)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well AZD2171 works in treating patients with refractory stage IV breast cancer

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluation of the fraction of patients with increased levels of circulating endothelial cells after 3 weeks of treatment with AZD2171.

II. Estimation of the objective response rate (ORR = CR + PR) among patients with refractory breast cancer receiving AZD2171.

SECONDARY OBJECTIVES:

  1. Estimation of the response/stable disease rate (RSDR = CR + PR + SD). II. Characterization of the toxicity associated with AZD2171 in this cohort of patients.

III. Analyses to correlate serial quantification of circulating endothelial cells and circulating tumor cells with traditional clinical endpoints including RR and TTP.

IV. Develop pharmacodynamic measures of AZ2171 activity based on monocyte count and VEGFR-1 phosphorylation within monocytes.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Being tested
cediranib maleate, laboratory biomarker analysis
Medical subject headings
Breast Neoplasms, Male, Breast Neoplasms

What participants receive

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

  • cediranib maleateDrug

    Also called AZD2171, Recentin

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00244881
Study groupRoleWhat they receive
Treatment (cediranib maleate)ExperimentalPatients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cediranib maleate; Other: laboratory biomarker analysis

What is being measured

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

  1. Fraction of Patients With Increased Levels of Circulating Endothelial Cells

    An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).

    Measured: After 3 weeks of treatment

  2. Objective Response Rate (ORR = CR + PR) Classified According to RECIST Criteria

    RECIST 1.0 Criteria

    Measured: Up to 7 years

Secondary outcomes (1)

  1. Response/Stable Disease Rate Defined as the Percentage of Patients Demonstrating CR + PR + SD

    Measured: 12 weeks

Timeline

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

  1. First posted27 Oct 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionAug 2007
  4. Study completionDec 2007

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00244881
Sponsor's protocol ID
NCI-2012-02937
Other IDs
05-160, U01CA062490, CDR0000445438
Status last verified
Nov 2013
First submitted
25 Oct 2005
Last updated
7 Dec 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cediranib maleate and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent 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 21 inclusion and 13 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 7 Dec 2015. 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?

Yes. Results are posted in the registry (first posted 23 Dec 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?

Fraction of Patients With Increased Levels of Circulating Endothelial Cells (time frame: After 3 weeks of treatment). 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 NCT00244881.

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 7 Dec 2015.

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