Advanced Breast Cancer MedDRA version: 9.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Product Name: CP-751,871
Pharmaceutical Form: Intravenous infusion
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: Taxotere
Pharmaceu
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY10017
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess Progression Free Survival (PFS) in patients randomized to CP-751,871 in combination with docetaxel and PFS in patients randomized to docetaxel alone as first line treatment for advanced breast cancer.;Secondary Objective: • To assess the overall response (CR+PR) in patients randomized to CP-751,871 in combination with docetaxel and in patients randomized to docetaxel alone; • To obtain preliminary survival information on patients randomized to CP-751,871 in combination with docetaxel and in patients randomized to docetaxel alone; • To assess the safety and tolerability of multiple doses of CP-751,871 in combination with docetaxel and in docetaxel alone; • To test for the presence of Circulating Tumor Cells (CTCs) expressing IGF-IR; • To collect PK data of CP-751,871 for population PK meta-analysis; • To monitor for the occurrence of Anti-Drug Antibodies (ADA) response to CP-751,871; • To examine the Patient Reported Outcomes of CP-751,871 in combination with docetaxel and in docetaxel alone.;Primary end point(s): Progression Free Survival (PFS): Defined as the time from randomization date to the date of progression or death due to any cause, whichever occurs first. Documentation of progression must be by objective disease assessment (based on caliper evidence (surface lesions) or imaging-based evidence) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). | — |
Countries
Spain, United Kingdom
Outcome results
None listed