SU11248 as Consolidation After Response to Taxanes in Metastatic Breast Cancer

NCT00270413 | Completed Phase 2

• 2 other identifiers: EudraCT 2005-004587-23UZL/MBC SUBE0501
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 13

Brief 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 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.

Conditions

Metastatic Breast Cancer

Keywords

breast cancer; metastatic; taxanes; SU11248

Outcome Measures

Primary Outcomes (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)

  5 months

Secondary Outcomes (5)

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

  1y

• To evaluate the safety and tolerability of SU011248

  1y

• To explore the correlations of potential biomarkers with clinical outcomes

  1y

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

  1y

• SU11248 treatment at the time progression after taxane chemotherapy.

  1y

Study Arms (2)

1

EXPERIMENTAL

sutent

Drug: SU11248

2

NO INTERVENTION

Interventions

SU11248 DRUG

sutent 50 mg daily 4w on 2w off

Also known as: sunitinib

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Pfizer: collaborator

Study Sites (13)

Imelda Bonheiden

Bonheiden, Belgium

Location

AZ st-jan brugge

Bruges, Belgium

Location

AZ VUB

Brussels, Belgium

Location

UCL

Brussels, Belgium

Location

Charleroi

Charleroi, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

ZOL

Hasselt, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Liege sart-tilman

Liège, Belgium

Location

Namur st-elisabeth

Namur, Belgium

Location

St-Elisabeth Turnhout

Turnhout, Belgium

Location

AZ st-augustinus

Wilrijk, Belgium

Location

Mont-Godinne

Yvoir, Belgium

Location

Related Publications (1)

• 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.

  PMID: 20652398 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• hans wildiers, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adjunct head of clinic

Study Record Dates

• First Submitted: December 23, 2005
• First Posted: December 26, 2005
• Study Start: January 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

BE (13)