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: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000198-29-GB
- Lead Sponsor
- MedImmune, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 178
Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy
Tumors are positive for ER, PgR, or both
Tumors must be negative for HER2 (by FISH or CISH)
Female gender and age = 18 years at time of study entry Postmenopausal
Karnofsky Performance Status = 70
Life expectancy of = 6 months
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 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
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
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
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