Overview

Pre-Operative Study of PF-4691502 With Letrozole Compared To Letrozole Alone In Patients With Early Breast Cancer

Status:
Terminated

Trial end date:
2012-12-01

Target enrollment:
0

Participant gender:
Female

Summary

PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or acquired resistance to hormonal therapy and restore hormone sensitivity in high risk (high Ki-67) patient population of hormone-sensitive breast cancers. In addition, Ki-67, a marker of cellular proliferation, could be used to select those patients who benefit from treatment with a PI3K-pathway inhibitor.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Letrozole

Criteria

Inclusion Criteria:

- Phase 1 - Postmenopausal women with diagnosis of breast cancer, metastatic disease or
locally advanced disease / Estrogen Receptor positive and HER-2 negative / candidate
to receive Letrozole

- Phase 2 - Postmenopausal women with newly diagnosed primary breast cancer / Estrogen
Receptor positive and HER-2 negative / Ki-67 levels >10% positive cells

- Phase 1 & 2 - Glucose control, adequate bone marrow, liver, renal, and cardiac
function

Exclusion Criteria:

- Inflammatory carcinoma / Prior therapy with an agent active on PI3K and/or mTOR /
Significant gastrointestinal abnormalities, which may impair intake, transit or
absorption of the study drugs / Current or anticipated need for food or drugs that are
known inhibitors or inducers of CYP3A4