EUCTR2011-000198-29-BE
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)
ConditionsAdvanced 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced Metastatic Breast Cancer (MBC)
- Sponsor
- MedImmune, LLC
- Enrollment
- 178
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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