EUCTR2011-000198-29-ES
Active, not recruiting
Phase 1
A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) Versus AI Alone in Women with Metastatic Breast Cancer (MBC)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MedImmune, LLC
- Enrollment
- 267
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
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,
Outcomes
Primary Outcomes
Not specified
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