A TWO-ARM RANDOMIZED OPEN LABEL PHASE 2 STUDY OF CP-751,871 IN COMBINATION WITH EXEMESTANE VERSUS EXEMESTANE ALONE AS FIRST LINE TREATMENT FOR POSTMENOPAUSAL PATIENTS WITH HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER - ND

• Conditions: Hormone receptor positive advanced breast cancer in postmenopausal women.; MedDRA version: 9.1Level: LLTClassification code 10057654Term: Breast cancer female

• Registration Number: EUCTR2006-005573-21-IT
• Lead Sponsor: Pfizer Inc,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-12
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study, unless there is compelling reason which is to be agreed by the investigator and sponsor prior to randomization: 1. Females >18 years of age. 2. Histologically or cytologically confirmed adenocarcinoma of the breast, either metastatic, or locally advanced Stage IIIB, or loco-regional recurrent and not amenable to curative treatment with surgery or radiotherapy. 3. Measurable or evaluable disease (See Appendix 7). 4. Patients must be postmenopausal. Postmenopausal is defined by any of the following: Woman >60 yrs; Amenorrhea for >5 years prior to randomization; Woman of age 45-59 yrs with spontaneous amenorrhea for >1 year prior to randomization; Woman of age 45-59 yrs with cessation of menses duration <1 year or secondary to hysterectomy AND with FSH levels pre-randomization clearly in the laboratory postmenopausal range (or >34.4 IU/L if institutional range is not available); Woman of age 45-59 yrs previously on HRT who discontinued HRT at breast cancer diagnosis and who has FSH level pre-chemotherapy or pre-randomization clearly in the laboratory postmenopausal range (or >34.4 IU/L if institutional range is not available); Bilateral oophorectomy; Ovarian ablation by radiotherapy confirmed by FSH level in the postmenopausal range. 5. Evidence of hormone sensitivity (ER+ and/or PR+) of primary or secondary tumor tissue according to the criteria of the participating Institution. 6. Must be appropriate to receive endocrine therapy as treatment for advanced disease. 7. Prior palliative radiotherapy is allowed. A measurable or evaluable lesion that has been previously irradiated will be evaluated only after it is considered to have progressed before randomization. Patients must have recovered from all acute radiation toxicities. 8. Patients must have HgbA1c<8.0%. 9. Concurrent bisphosphonate treatment is allowed but not required. Patients on bisphosphonates at randomization must be kept on bisphosphonate during the study(see also Concomitant Medications Section). 10. Patients must have an ECOG performance status 0, 1, or 2 (See Appendix 5). 11. Adequate recovery from major surgery prior to randomization. Wound healing must be complete. 12. Patients must have adequate hematologic function as defined by: ANC >/=1500/mm3; Platelets >/=100000/mm3; Hemoglobin >/=8.5 g/Dl. 13. Patients must have adequate renal and liver function as defined by: Serum creatinine and serum bilirubin level 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 study, unless there is compelling reason which is to be agreed by the investigator and sponsor prior to randomization: 1. Male patients. 2. Presence of life threatening metastatic disease defined as extensive (more than one third of the organ) hepatic involvement, any past or present brain or leptomeningeal involvement, or symptomatic pulmonary lymphangitic spread (>50% lung involvement). Patients with discrete pulmonary parenchymal metastases will not be excluded as long as their respiratory function is not compromised. 3. Presence of unevaluated central nervous system (CNS) symptoms suggestive of brain metastases within 2 weeks prior to randomization. CNS symptoms must be evaluated by CT or MRI scan. 4. Patients who are highly symptomatic from their breast cancer, or who require urgent palliative chemotherapy, as decided by their treating physician. 5. Adjuvant/neoadjuvant therapy with steroidal aromatase inhibitors within 12 months of randomization. 6. Adjuvant/neoadjuvant tamoxifen within 2 weeks of randomization. 7. Adjuvant/neoadjuvant chemotherapy (excluding anthracycline) within 4 weeks of randomization. 8. Adjuvant/neoadjuvant anthracycline and/or trastuzumab therapy within 6 months of randomization. 9. Prior anti-IGF-1R investigational therapy. 10. Prior therapy for metastatic/advanced disease including, but not limited to, chemotherapy, hormonal (eg, tamoxifen, SERMs, LHRH agonists, ovariectomy, radiocastration) or targeted therapy, including immunotherapy. Prior AI is allowed if less than 4 weeks prior to randomization. 11. Patients with a known hypersensitivity to exemestane or to any of its excipients. 12. Patients with a known hypersensitivity to antibody therapy. 13. 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. 14. A serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment. 15. Significant active cardiac disease including: uncontrolled high blood pressure (ie, systolic blood pressure >/=180 mm Hg, diastolic blood pressure >/=95 mm Hg), unstable angina, deep venous thrombosis, pulmonary embolism, endocarditis, cerebro-vascular attack, valvular disease, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias. 16. Use of high dose corticosteroids within 2 weeks prior to randomization ( >/=100 mg prednisone per day or >/= 40 mg dexamethasone per day). 17. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 18. Any other major illnesses or laboratory abnormality that, in the Investigator?s judgment, will substantially increase the risk associated with the patient?s participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified