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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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9 October 2012 |
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Main ID: |
EUCTR2006-004693-27-SE |
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Date of registration:
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19/12/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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A RANDOMISED, PHASE 3 STUDY OF DOCETAXEL IN COMBINATION WITH SUNITINIB VERSUS DOCETAXEL IN THE FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER PATIENTS -
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Date of first enrolment:
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13/03/2007 |
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Target sample size:
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550 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004693-27 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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:
Other:
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Phase:
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Countries of recruitment
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Austria
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Czech Republic
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Finland
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France
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Germany
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Hungary
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Ireland
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Italy
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Netherlands
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Portugal
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Histologically or cytologically proven diagnosis of breast cancer with evidence of
1) unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent
disease must not be amenable to resection or radiation therapy with curative intent.
2. Her-2 negative breast cancer (i.e., FISH or CISH (where approved) negative or
immunohistochemistry 0 or +1).
3. Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST)
or bone-only disease.
4. The following patients are eligible:
• Patients not candidate for adjuvant chemotherapy at first diagnosis who
relapsed with distant metastases
• Patients candidate for adjuvant or neo-adjuvant hormonal therapy at first
diagnosis who relapsed with distant metastases.
• Patients candidate for adjuvant or neo-adjuvant cytotoxic therapy at first
diagnosis who relapsed with locally advanced or metastatic disease
• If adjuvant or neo-adjuvant therapy included also a taxane, relapse
must have occurred =12 months since completion of chemotherapy.
• Hormonal therapy concurrent or sequential to adjuvant chemotherapy
is allowed.
• Hormonal therapy for advanced disease is allowed but is to be discontinued
prior to the start of study treatment.
• Patients with bone-only disease that are hormone receptor-positive must have
progressed during or after hormone therapy prior to entering the trial.
5. Must be candidate for treatment with docetaxel.
6. May have received prior radiation therapy. A measurable lesion that has been
previously irradiated will be evaluated only when it increases in size. Radiotherapy
is to be completed prior to screening disease assessments.
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
=1 (except alopecia or other toxicities not considered a safety risk for the patient).
10. Adequate organ function as defined by the following criteria:
• Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =1.5
x upper limit of normal (ULN), or AST and ALT =2.5 x ULN if liver function
abnormalities are due to underlying malignancy.
• Deleted in Amendment 2 (Alkaline phosphatase (ALP) =2.5 x ULN).
• Total serum bilirubin <1 x ULN. [patients suffering from Gilbert’s disease are
allowed to enter the study]
• Serum albumin =2.5 g/dL.
• Absolute neutrophil count (ANC) =1500/µL.
• Platelets =100,000/µL.
• Hemoglobin =8.5 g/dL.
• Serum creatinine =1.5 x ULN.
• 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. Clinical presentation of inflammatory carcinoma with no other measurable disease.
2. Prior treatment with chemotherapy in the metastatic disease setting.
3.Prior treatment on a sunitinib clinical trial.
4. Patients for whom docetaxel is contraindicated according to the local prescribing
information.
5. History of severe hypersensitivity reactions to docetaxel or to other drugs
formulated with polysorbate 80.
6. AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN.
7. Major surgery, or systemic therapy (with the exception of hormonal therapy) within
3 weeks of start of study treatment. At least 1 week should elapse since minor
surgical procedures including placement of an access device or fine needle
aspiration.
8. Deleted in Amendment 2 (Prior high-dose chemotherapy requiring hematopoietic
stem cell rescue).
9. Deleted in Amendment 2 (Prior radiation therapy to >25% of the bone marrow).
10. Current treatment on another clinical trial.
11. History or presence of brain metastases, presence of spinal cord compression, or
carcinomatous meningitis, or leptomeningeal disease.
12. Diagnosis of any second malignancy within the last 3 years, except for adequately
treated basal cell carcinoma or squamous cell skin cancer or in situ carcinoma of
the cervix uteri.
13. Any of the following within the 6 months prior to starting study treatment:
myocardial infarction, severe/unstable angina, congestive heart failure,
cerebrovascular accident including transient ischemic attack, or pulmonary
embolus.
14. Ongoing cardiac dysrhythmias of grade =2, or QTc interval >470 msec.
15. Hypertension that cannot be controlled by medications (>150/100 mmHg despite
optimal medical therapy).
16. Current treatment with therapeutic doses of coumarin derivatives such as warfarin and phenprocoumon (low dose for deep vein thrombosis prophylaxis is allowed) or oral anti-vitamin K agents. Treatment with therapeutic doses of low-molecularweight heparin is allowed.
17. Known human immunodeficiency virus infection.
18. Pregnancy or breastfeeding. Female patients who are pregnant or nursing, female of child-bearing potential who is unwilling or unable to use adequate contraception to prevent pregnancy during the trial and for 3 months after the last dose of study treatment. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study entry.
19. 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. Prior treatment on a sunitinib clinical trial.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Advanced breast cancer
MedDRA version: 9.1
Level: LLT
Classification code 10006187
Term: Breast cancer
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Intervention(s)
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Trade Name: SUTENT
Product Name: Sutent
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib malate
CAS Number: 341031-54-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 12.5-50
Trade Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: docetaxel
CAS Number: 1327-53-3.
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 20-80
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Primary Outcome(s)
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Main Objective: To demonstrate that the combination of docetaxel with sunitinib is superior to docetaxel in prolonging PFS in patients with advanced breast cancer.
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Primary end point(s): Progression-free survival (PFS).
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Secondary Objective: To compare the clinical benefit in patients treated with the 2 regimens.
To compare the safety of the 2 regimens.
To compare the patient reported outcomes of patients treated with the 2 regimens.
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Secondary ID(s)
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A6181064
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2006-004693-27-CZ
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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