SU11248 as Consolidation After Response to Taxanes in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270413
• Other study ID #: EudraCT 2005-004587-23
• Secondary ID: UZL/MBC SUBE0501
• Status: Completed
• Phase: Phase 2
• Start date: January 2006
• Est. completion date: March 2009

Study information

• Verified date: November 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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
• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• SU11248
sutent 50 mg daily 4w on 2w off

Locations

Country	Name	City	State
Belgium	Imelda Bonheiden	Bonheiden
Belgium	AZ st-jan brugge	Brugge
Belgium	AZ VUB	Brussels
Belgium	UCL	Brussels
Belgium	Charleroi	Charleroi
Belgium	UZ Gent	Gent
Belgium	ZOL	Hasselt
Belgium	UZ Leuven	Leuven
Belgium	Liege sart-tilman	Liege
Belgium	Namur st-elisabeth	Namur
Belgium	St-Elisabeth Turnhout	Turnhout
Belgium	AZ st-augustinus	Wilrijk
Belgium	Mont-Godinne	Yvoir

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Pfizer

Country where clinical trial is conducted

Belgium, 

References & 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 taxa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare other measures of antitumor efficacy in both treatment arms of the study		1y
Secondary	To evaluate the safety and tolerability of SU011248		1y
Secondary	To explore the correlations of potential biomarkers with clinical outcomes		1y
Secondary	To confirm efficacy of SU11248 in patients of the control group, who receive delayed		1y
Secondary	SU11248 treatment at the time progression after taxane chemotherapy.		1y