A study in women with advanced breast cancer treated with standard therapy with or without MEDI-573

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 267

Inclusion Criteria

Subjects must meet the following criteria:
Female gender and age ? 18 years at time of study entry
Women must be postmenopausal
Written informed consent and any locally-required authorization
Have histologically-confirmed metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
Life expectancy of ? 6 months
Subjects must have adequate organ and marrow function
Suitable candidate for AI, including the ability to swallow and absorb oral agents
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 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Any of the following would exclude the subject from participation in the study:

Concurrent enrollment in another clinical study testing an investigational agent or
intervention for cancer treatment or prevention
Subject directly involved with the conduct of the study or an immediate family
member of any such individual
Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or
biologic therapy for advanced or metastatic disease (except Prior adjuvant therapy with an AI is allowed, provided treatment ended at least 1 year prior to the first dose of therapy; Prior treatment with tamoxifen is allowed, provided treatment ended at least; 1 week prior to the first dose of therapy; Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed)
History of allergy or reaction attributed to compounds of chemical or biologic
composition similar to those of MEDI-573 or AI
Subject for whom endocrine therapy of breast cancer is not appropriate (ie,
life-threatening or rapidly progressing metastatic disease)
Subjects with extensive symptomatic visceral disease including hepatic
involvement and pulmonary lymphangitic spread of tumor, or disease that is
considered by the investigator to be rapidly progressing or life threatening (eg,
subjects who are intended for chemotherapy)
Known central nervous system metastases or leptomeningeal carcinomatosis
Evidence of spinal cord compression
Unresolved toxicities from prior therapy with the exception of alopecia that have not
resolved to ? Grade 1 (by National Cancer Institute Common Terminology Criteria
for Adverse Events [NCI CTCAE] version 4.0) at the time of starting study treatment
Receipt of any investigational therapy within 30 days or 5 half-lives, whichever is
longer, prior to receiving the first dose of study treatment
Previous treatment with agents that target the IGF receptor
Use of immunosuppressive medication other than steroids within 7 days before the
first dose of MEDI-573
History of another primary malignancy within 5 years prior to starting study treatment
except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the
cervix
Poorly controlled diabetes mellitus as defined by investigator assessment and/or
hemoglobin A1c (HbA1c) > 8% within 21 days prior to randomization
History of cardiac disease including, but not limited to, congestive heart failure
> Class II New York Heart Association (see Appendix 3), active coronary artery
disease (eg, unstable angina pectoris), new onset angina pectoris, myocardial
infarction within the past 6 months, ventricular arrhythmias requiring antiarrhythmic
therapy, or uncontrolled hypertension within the last 6 months
Current active hepatic or biliary disease (with exception of subjects with Gilbert?s
syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease
per investigator assessment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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