A study in women with advanced breast cancer treated with standard therapy with or without MEDI-573
- Conditions
- Advanced Metastatic Breast Cancer (MBC)MedDRA version: 20.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000198-29-BE
- Lead Sponsor
- MedImmune, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 178
Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy (subjects with bone metastases are eligible but enrollment will be capped at approximately 30 subjects)
Tumors are positive for ER, PgR, or both
Tumors must be negative for HER2 (by FISH, CISH or ICH)
Female gender and age = 18 years at time of study entry
Postmenopausal
Karnofsky Performance Status = 70
Life expectancy of = 6 months
Adequate organ and marrow function
Suitable candidate for AI therapy
Consent to allow collection of available paraffin-embedded tumor tissue
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:
Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573
Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
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)
Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573
Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis
Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to = Grade 1 at the time of starting study treatment
Receipt of any investigational therapy within 30 days or 5 half-lives, prior to recieving study treatment
Previous treatment with agents that target the IGF receptor
History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI
Use of immunosuppresive med other than steroids within 7d before 1st dose of study drug
History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix
Poorly controlled diabetes mellitus
History of cardiac disease within past 6 mo
Active hepatic liver or biliary disease (with exceptions)
Known immunodeficiency virus or hep B or C (active, previously treated)
Active infection
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