Breast Cancer Clinical Trial

A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.

Summary

This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years.

Histologically or cytologically documented unresectable, locally advanced or metastatic breast cancer or gastric cancer refractory to standard therapy.

For subjects with breast cancer:

Prior treatment with trastuzumab, pertuzumab, and T-DM1, either alone or in combination, is required.
Subjects with a primary tumor that is hormone (estrogen, progesterone, or both) receptor-positive or receptor-negative are eligible.
Prior hormone therapy is allowed, but last dose must be at least 14 days prior to first dose of MEDI4276.

For subjects with gastric cancer:

Prior treatment with a trastuzumab containing chemotherapy regimen is required.
HER2 Positive disease documented as FISH-positive and/or 3+ by IHC on previously collected tumor tissue.
At least one lesion measurable by RECIST Version 1.1.

Exclusion Criteria:

Receipt of any conventional or investigational anticancer treatment within 28 days prior to the first dose of MEDI4276.

History of exposure to the following cumulative doses of anthracyclines:

Doxorubicin or liposomal doxorubicin >350 mg/m².
Epirubicin >530 mg/m².
Mitoxantrone >90 mg/m² and idarubicin > 70 mg/m².
If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 350 mg/m² of doxorubicin.
Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery or other therapy to control symptoms from brain metastases within 2 months prior to first dose of MEDI4276.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

47

Study ID:

NCT02576548

Recruitment Status:

Completed

Sponsor:

MedImmune LLC

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There are 5 Locations for this study

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Research Site
Stanford California, 94305, United States
Research Site
Sarasota Florida, 34232, United States
Research Site
Indianapolis Indiana, 46202, United States
Research Site
Charlotte North Carolina, 28204, United States
Research Site
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

47

Study ID:

NCT02576548

Recruitment Status:

Completed

Sponsor:


MedImmune LLC

How clear is this clinincal trial information?

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