A RANDOMIZED PHASE 2, OPEN-LABEL STUDY OF CP-751,871 IN COMBINATION WITH DOCETAXEL AND DOCETAXEL ALONE AS A FIRST LINE TREATMENT OF PATIENTS WITH ADVANCED BREAST CANCER

Conditions: Advanced Breast Cancer
MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

Registration Number: EUCTR2008-001298-13-GB

Lead Sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY10017

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 200

Inclusion Criteria

Patients should meet all of the following inclusion criteria to be eligible for enrollment into the study, unless there is a compelling reason which is to be agreed by the investigator and sponsor prior to randomization:
1. Women at least 18 years of age.
2. Histologically or cytologically confirmed diagnosis of breast cancer with evidence of
either metastatic disease (Stage IV) or locally recurrent disease not amenable to
curative resection or radiation therapy (Stage IIIB).
3. Her-2 negative breast cancer (ie, FISH negative or IHC 0-1+) or unknown Her-2
status.
4. At least one measurable lesion as defined by RECIST.
5. Prior radiotherapy (more than 1 week prior to randomization) is allowed, provided is not at the only site of measurable disease. A measurable lesion that has been
irradiated will be considered measurable only when it increases in size. Patients must
have recovered from all acute toxicities before randomization.
6. For patients progressing on hormonal therapy for advanced disease, hormonal therapy must be discontinued at least 1 week prior to randomization.
7. Resolution from all acute toxic effects of prior therapy or surgical procedure to CTC
grade =1 (except alopecia or other AE that does not constitute a safety risk).
8. Patients must be candidate for docetaxel treatment according to the local prescribing information.
9. Concurrent bisphosphonate treatment is allowed if established at least two weeks
before randomization.
10. Patients must have an ECOG performance status 0-1 (See Appendix 3).
11. Patients must have adequate hematologic, renal, liver and cardiac function
documented prior to randomization as defined by the following, unless otherwise
agreed by the investigator and sponsor:
• ANC =1.5 x 109/L;
• Platelets =100 x 109/L;
• Hemoglobin =8 g/dL;
• Serum creatinine level =1.5 x ULN;
• Serum bilirubin = ULN;
• ALT and/or AST =2.5 x ULN; however, ALT and/or AST =1.5 ULN if concomitant with alkaline phosphatase >2.5 x ULN;
• Alkaline phosphatase =5 x ULN;
• Left ventricular ejection fraction =50% as measured either by either multigated acquisition (MUGA) scan or Echocardiogram (ECHO);
12. Female patients or their partners must be surgically sterile or be postmenopausal, or must agree to use adequate contraception while receiving study treatment and for at least 5 months thereafter. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) within one week (preferably 72 hours) prior to starting treatment. The definition of adequate contraception will be included in the patient’s informed consent; according to local regulations. Female patients may not be nursing.
13. Signed and dated informed consent.
14. Patients who are willing and able to comply with scheduled visits, treatment plan,
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

Patients presenting with any of the following will not be included in the trial, unless there is a compelling reason which is to be agreed by the investigator and sponsor prior to randomization:
1. Any previous chemotherapy for advanced disease.
2. Prior exposure to taxanes as (neo)adjuvant treatment less than 12 months before
randomization.
3. Prior anti-IGF-IR based investigational therapy.
4. Prior investigational therapy within 4 weeks from randomization.
5. Symptomatic brain metastases. Brain metastases stable for <2 weeks before dosing or requiring concurrent steroid therapy or with clinical symptoms. Clinical symptoms suggestive of new brain metastasis within 2 weeks of randomization. If such evidence exists, new brain metastasis must be ruled out by a CT scan or MRI.
6. Peripheral neuropathy > Grade 2.
7. Surgery within 4 weeks prior to randomization.
8. Radiation therapy to more than 25% of the bone marrow.
9. History of severe hypersensitivity reactions to docetaxel or to other drugs formulated in polysorbate 80.
10. Patients with a known hypersensitivity to antibody therapy.
11. Use of high dose of corticosteroids within 2 weeks prior to enrollment (>100 mg
prednisone per day or >40 mg dexamethasone per day).
12. History of malignancy other than breast cancer within 5 years before study start with the exception of appropriately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
13. A serious uncontrolled medical disorder or active infection (eg, HIV and HVB).
14. Significant active cardiac disease including: uncontrolled high blood pressure (ie,
systolic blood pressure >180 mmHg, diastolic blood pressure >95 mmHg despite
optimal medical therapy), unstable angina, deep venous thrombosis, pulmonary
embolism, cerebro-vascular attack, valvular disease, congestive heart failure,
myocardial infarction within the previous 6 months, or serious cardiac arrhythmias.
15. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol.