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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.

Register:	EUCTR
Last refreshed on:	9 October 2012
Main ID:	EUCTR2006-004693-27-IT
Date of registration:	06/04/2007
Prospective Registration:	No
Primary sponsor:	PFIZER
Public title:
Scientific title:	A RANDOMISED, PHASE 3 STUDY OF DOCETAXEL IN COMBINATION WITH SUNITINIB VERSUS DOCETAXEL IN THE FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER PATIENTS - ND
Date of first enrolment:	19/12/2006
Target sample size:	550
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004693-27
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:

Countries of recruitment
Austria	Czech Republic	Finland	France	Germany	Hungary	Ireland	Italy
Netherlands	Portugal	Spain	Sweden	United Kingdom

Contacts

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Key inclusion & exclusion criteria

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 . 4. Must have received prior adjuvant or neo-adjuvant anthracycline-based therapy If 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 / 3 weeks prior to study randomization. 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 / 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 / 1 except alopecia . 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. Alkaline phosphatase ALP / 2.5 x ULN. Total serum bilirubin 1 x ULN. Serum albumin / 3.0 g/dL. Absolute neutrophil count ANC / 1500/ L. Platelets / 100,000/ L. Hemoglobin / 9.0 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. 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, radiation therapy, or systemic 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. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 9. Prior radiation therapy to 25 of the bone marrow whole pelvis is 25 . 10. Current treatment on another clinical trial. 11. Presence of brain metastases, spinal cord compression, 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 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, or pulmonary embolus. 14. Ongoing cardiac dysrhythmias of grade / 2, atrial fibrillation of any grade, 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 Coumadin low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis 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 program 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.

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

Health Condition(s) or Problem(s) studied

Advanced Breast Cancer ABC
MedDRA version: 9.1 Level: LLT Classification code 10055113 Term: Breast cancer metastatic

Intervention(s)

Trade Name: SUTENT
Pharmaceutical Form: Capsule, hard
CAS Number: 152459-95-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-

Trade Name: SUTENT
Pharmaceutical Form: Capsule, hard
CAS Number: 152459-95-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: TAXOTERE INFUS FL 20MG/0,5ML F
Pharmaceutical Form: Concentrate for solution for infusion
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: TAXOTERE INFUS FL 80MG/2ML F
Pharmaceutical Form: Concentrate for solution for infusion
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-

Trade Name: SUTENT
Pharmaceutical Form: Capsule, hard
CAS Number: 152459-95-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: To demonstrate that the combination of docetaxel with sunitinib is superior to docetaxel in prolonging PFS in patients with advanced breast cancer who have relapsed after an anthracycline-based chemotherapy in the adjuvant setting.

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.

Primary end point(s): Progression-free survival PFS .

Secondary Outcome(s)

Secondary ID(s)

A6181064

2006-004693-27-CZ

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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