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Metastatic Breast CancerPhase 2NCT00270413

SU11248 as Consolidation After Response to Taxanes in Metastatic Breast Cancer

A Phase 2 study testing SU11248 in people with Metastatic Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 13 sites in Belgium.

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

This study tests the hypothesis that SU11248 can delay tumor progression after tumor mass reduction by taxanes. This is a dual-arm open-label randomized multicenter phase II clinical trial with 2:1 randomization evaluating the efficacy of SU11248 versus nil in patients with metastatic breast cancer after objective… 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?
SU11248
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
13 sitesBelgium
Study dates
Jan 2006to Mar 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with metastatic breast cancer, histologically proven
  • Patients received taxane based chemotherapy resulting in PR or CR, and thus had measurable disease at the start of taxane therapy (RECIST)
  • No more than 2 lines (taxanes included) in metastatic setting
  • Patients have received at least 10 weeks of taxane therapy (4 cycles of 3-weekly therapy or 8 weekly administrations) and no more than 20 weeks of treatment (6 cycles of 3-weekly therapy or 16 weekly administrations). 6 cycles of 3-weekly taxanes or 12-16 cycles of weekly taxanes are recommended.
  • Last taxane administration between 3 and 4 weeks for 3 weekly taxane or between 2 and 3 weeks for weekly taxanes
  • Performance status 0 to 1 on the ECOG scale (Appendix A)
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  • Age > 18 years
  • Adequate organ function as defined by:
  • Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) ≤2.5 x central laboratory upper limit of normal (CL-ULN). If liver function abnormalities are due to underlying malignancy, then AST and ALT may be ≤5 x CL-ULN
  • Prothrombin time (PT) > 50%
  • Serum albumin ≥3.0 g/dL
  • Absolute neutrophil count (ANC) ≥1500/µL
  • Platelets ≥100,000/µL
  • Hemoglobin ≥9.0 g/dL
  • Serum creatinine ≤1.5 x CL-ULN
  • Serum amylase and lipase ≤1.0 x CL-ULN
  • Left ventricular ejection fraction (LVEF) above the lower limit of normal (LLN) as assessed by multigated acquisition (MUGA) scan or echocardiography.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Who cannot join

  • Her2 neu positive tumor with IHC 3+ or FISH+
  • Concurrent hormone therapy (tamoxifen, aromatase inhibitors, other hormone suppressing therapies) with SU11248.
  • Concurrent treatment with hormonal replacement therapy
  • Concurrent treatment with any other anti-cancer therapy. Bisphosphonates are allowed.
  • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 20 days prior to study entry. Previous trials with antiangiogenic drugs is not allowed.
  • Chronic treatment with steroids unless initiated > 6 months prior to study entry and at low dose (< 20 mg methylprednisolone daily or equivalent)
Show all 12Show fewer
  • Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
  • Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
  • Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS)-related illness.
  • Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Belgium13 sites

  • Imelda Bonheiden

    Bonheiden

  • AZ st-jan brugge

    Bruges

  • AZ VUB

    Brussels

  • UCL

    Brussels

  • Charleroi

    Charleroi

  • UZ Gent

    Ghent, 9000

  • ZOL

    Hasselt

  • UZ Leuven

    Leuven, 3000

  • Liege sart-tilman

    Liège

  • Namur st-elisabeth

    Namur

  • St-Elisabeth Turnhout

    Turnhout

  • AZ st-augustinus

    Wilrijk

  • Mont-Godinne

    Yvoir

Other trials in Belgium

About this study

Official title: A Belgian Multicenter Phase II Randomized Trial in her2 Negative Metastatic Breast Cancer Evaluating Consolidation Antiangiogenic Therapy With SU11248 After Response to Taxane Chemotherapy Induction

This study tests the hypothesis that SU11248 can delay tumor progression after tumor mass reduction by taxanes. This is a dual-arm open-label randomized multicenter phase II clinical trial with 2:1 randomization evaluating the efficacy of SU11248 versus nil in patients with metastatic breast cancer after objective response to taxane chemotherapy. Patients randomized to the placebo arm (Arm B) will be offered the opportunity to receive open-label SU011248 treatment upon development of Response Evaluation Criteria in Solid Tumors (RECIST)-defined disease progression.

Read the detailed description

This study tests the hypothesis that SU11248 can delay tumor progression after tumor mass reduction by taxanes. This is a dual-arm open-label randomized multicenter phase II clinical trial with 2:1 randomization evaluating the efficacy of SU11248 versus nil in patients with metastatic breast cancer after objective response to taxane chemotherapy. Patients randomized to the placebo arm (Arm B) will be offered the opportunity to receive open-label SU011248 treatment upon development of RECIST-defined disease progression

Being tested
SU11248
Keywords
breast cancer, metastatic, taxanes, SU11248
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.

  • SU11248Drug

    Also called sunitinib

    sutent 50 mg daily 4w on 2w off

Study groups in NCT00270413
Study groupRoleWhat they receive
1Experimentalsutent
Receives: Drug: SU11248
2No interventionNot described

What is being measured

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

  1. Progression Free Survival (PFS) at 5 months (= proportion of patients alive and free of progression 5 months after starting therapy in the sunitinib arm (control arm = only for descriptive purpose)

    Measured: 5 months

Secondary outcomes (5)

  1. To compare other measures of antitumor efficacy in both treatment arms of the study

    Measured: 1y

  2. To evaluate the safety and tolerability of SU011248

    Measured: 1y

  3. To explore the correlations of potential biomarkers with clinical outcomes

    Measured: 1y

  4. To confirm efficacy of SU11248 in patients of the control group, who receive delayed

    Measured: 1y

  5. SU11248 treatment at the time progression after taxane chemotherapy.

    Measured: 1y

Timeline

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

  1. First posted26 Dec 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionMar 2009
  4. Study completionMar 2009

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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00270413
Sponsor's protocol ID
EudraCT 2005-004587-23
Other IDs
UZL/MBC SUBE0501
Status last verified
Nov 2022
First submitted
23 Dec 2005
Last updated
22 Nov 2022
Results posted
No
Data monitoring committee
No

Publications

  • Wildiers H, Fontaine C, Vuylsteke P, Martens M, Canon JL, Wynendaele W, Focan C, De Greve J, Squifflet P, Paridaens R. Multicenter phase II randomized trial evaluating antiangiogenic therapy with sunitinib as consolidation after objective response to taxane chemotherapy in women with HER2-negative metastatic breast cancer. Breast Cancer Res Treat. 2010 Sep;123(2):463-9. doi: 10.1007/s10549-010-1066-x. Epub 2010 Jul 22.

    PubMed 20652398

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SU11248 in people with Metastatic Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 13 sites in Belgium.

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 19 inclusion and 12 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 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression Free Survival (PFS) at 5 months (= proportion of patients alive and free of progression 5 months after starting therapy in the sunitinib arm (control arm = only for descriptive purpose) (time frame: 5 months). 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 NCT00270413, 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 22 Nov 2022.

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