Phase III Randomized, Multi Center Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2006-001267-33-FR
• Date of registration: 05/12/2006
• Prospective Registration: Yes
• Primary sponsor: PFIZER
• Public title: Phase III Randomized, Multi Center Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated
• Scientific title: Phase III Randomized, Multi Center Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated
• Date of first enrolment: 01/03/2007
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001267-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, France, Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Histologically or cytologically proven diagnosis of breast adenocarcinoma that is
not amenable to surgery, radiation, or combined modality therapy with curative
intent
2. Measurable disease as per RECIST. Measurable lesions that have been
previously radiated will not be considered target lesions unless increase in size
has been observed following completion of radiation therapy.
3. Tumor must be HER 2 negative (immunostaining 0, 1+ or FISH negative)
4. Must have received prior treatment with an anthracycline and a taxane either
concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced
disease treatment settings. No more than 1 chemotherapy regimen in the
advanced setting.
5. Must have received an adequate course of anthracyclines, considered standard
for adjuvant and/or metastatic disease therapy. Prior hormonal therapy or
immunotherapy in the adjuvant and/or advanced/metastatic disease settings
permitted but is to be discontinued at least 3 weeks before enrollment in the
study.
6. May have received prior radiation therapy. A measurable lesion that has been
previously irradiated will not be considered as target lesion and will be evaluated
only when it increases in size. Radiotherapy is to be completed = 3 weeks prior to
study randomization.
7. Female, 18 years of age or older.
8. ECOG performance status 0 or 1.
9 Resolution of all acute toxic effects of prior therapy or surgical procedures to
grade minor than/equal to 1 (except alopecia).

10. Adequate organ function as defined by the following criteria:
· Serum aspartate transaminase (AST) and serum alanine transaminase (ALT)
less than/equal to 2.5 x upper limit of normal (ULN) or AST and ALT less
than/equal to 5 x ULN if liver function abnormalities are due to underlying
malignancy
· Alkaline phosphatase (ALP) less than/equal to 2.5 x ULN
· Total serum bilirubin <1.5 x ULN
· Serum albumin =3.0 g/dL
· Absolute neutrophil count (ANC) = 1500/uL
· Platelets = 100,000/uL
· Hemoglobin =9.0 g/dL
· Serum creatinine less than/equal to 1.5 x ULN "or calculated creatinine clearance =50 ml/min"
· Left ventricular ejection fraction (LVEF) =50% as measured by either
multigated acquisition (MUGA) scan or echocardiogram (ECHO)
11. Signed and dated informed consent document indicating that the patient (or
legally acceptable representative) has been informed of all the pertinent
aspects of the trial prior to enrollment.
12. Willingness and ability to comply with scheduled visits, treatment plans,
laboratory tests, and other study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Prior treatment with regimens of chemotherapy in the advanced/metastatic
disease setting beyond those containing anthracyclines and taxanes or multiple
anthracyclines/ taxanes treatments. Any prior regimen with capecitabine
2. Major surgery, radiation therapy, or systemic therapy within 3 weeks of first
study treatment. At least 7 days should elapse from the time of minor surgical
procedure including placement of an access device or fine needle aspiration
before randomization into this study can occur.
3. Wounds that have not completely healed, active ulcer(s), or bone fracture(s).
4. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
5. Prior radiation therapy to >25% of the bone marrow.
6. Current treatment on another clinical trial.
7. Brain metastases, spinal cord compression, or carcinomatous meningitis, or
leptomeningeal disease.
8. Bone lesions as the only manifestation of current metastatic breast cancer.
9. Diagnosis of any second malignancy within the last 3 years, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
10. Any of the following within the 12 months prior to starting study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery
bypass graft, congestive heart failure, cerebrovascular accident including
transient ischemic attack, pulmonary embolus, deep vein thrombosis or other
significant thromboembolic events.
11. Ongoing cardiac dysrhythmias of NCI CTCAE grade =2, atrial fibrillation of any
grade, or QTc interval >470 msec for females.
12. Hypertension that cannot be controlled by medications (>150/100 mmHg
despite optimal medical therapy).
13. Current treatment with therapeutic doses of anticoagulant (low dose Coumadin
up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). Low
molecular weight heparin monitored by INR is allowed.
14. Known human immunodeficiency virus infection.
15. Female patients who are pregnant or nursing, Female patients of child-bearing
potential who are unwilling or unable to use adequate contraception to prevent
pregnancy during the program. All female patients with reproductive potential
must have a negative pregnancy test (serum or urine) prior to first day of study
medication..
16. Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that would impart, in the judgment of the investigator, excess risk
associated with study participation or study drug administration, or which, in the
judgment of the investigator, would make the patient inappropriate for entry
into this study.
17. Known hypersensitivity to 5-fluorouracil or capecitbabine
18. Known dihydropyrimidine dehydrogenase deficiency.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Histologically or cytologically proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent

Intervention(s)

Product Name: sunitinib malate
Product Code: SU011248
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib malate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5 - 25 - 50-

Trade Name: XELODA
Product Name: XELODA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: capecitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150 - 500-

Primary Outcome(s)

Secondary Objective: To assess
• Time to Tumor Progression (TTP)
• Overall Response
• Duration of Response
• Time to Tumor Response
• Overall Survival
• Patient Reported Outcomes (PRO’s)
• Safety
of sunitinib malate at a starting dose of 37.5 mg orally once daily and of capecitabine at a dose of 1,250 or 1,000 (in patients older than 65 years) mg/m2 twice a day for 2 consecutive weeks, followed by a 1-week rest period and given as 3 weeks cycles.

Main Objective: To compare the progression-free survival (PFS) of subjects with advanced breast cancer receiving sunitinib malate at a starting dose of 37.5 mg orally once daily with that of capecitabine at a dose of 1250 or 1000 (1000 in patients older than 65 years) mg/m2 twice a day for 2 consecutive weeks, followed by a 1-week rest period and given as 3 weeks cycles.

Primary end point(s): Progression Free Survival (PFS) is defined as the time from date of randomization to first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

Secondary ID(s)

2006-001267-33-DE

A6181107

Ethics review

Status: Approved
Approval date: 01/03/2007
Contact:

Results

• Results available: Yes
• Date Posted: 06/02/2015
• Date Completed: 15/06/2011
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-001267-33/results