NCT00338728

Letrozole and Imatinib Mesylate in Treating Postmenopausal Participants With Estrogen or Progesterone Positive Metastatic Breast Cancer

Phase II Study of Letrozole (Femara) Plus Imatinib Mesylate (Gleevec) for Postmenopausal Patients With ER and/or PR Positive Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well letrozole and imatinib mesylate work in treating postmenopausal participants with estrogen or progesterone positive breast cancer that has spread to other places in the body. Letrozole is an antihormonal drug used in the standard treatment of hormonal sensitive breast cancer. Imatinib mesylate is a drug that binds to certain proteins on the tumor cells and prevents them from further growth. Imatinib mesylate is thought to prevent the potential resistance to letrozole, which may make the letrozole more effective. Giving letrozole and imatinib mesylate may work better in treating participants with breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the efficacy of letrozole plus imatinib mesylate in patients with estrogen receptor (ER) and or progesterone receptor (PgR) positive metastatic breast cancer. II. To determine the safety and tolerability of letrozole plus imatinib mesylate in patients with metastatic breast cancer. III. To determine the time to disease progression and overall survival in patients with metastatic breast cancer who are treated with letrozole plus imatinib mesylate. OUTLINE: Participants receive imatinib mesylate orally (PO) twice daily (BID) and letrozole PO once daily (QD) for 8 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 1 and 4 weeks and at 2, 4, 6, 9, and 12 months.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Estrogen Receptor Positive
• KIT Positive
• PDGFR Positive
• Postmenopausal
• Progesterone Receptor Positive
• Prognostic Stage IV Breast Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Imatinib Mesylate	Given PO
DRUG	Letrozole	Given PO

Timeline

• Start date: 2003-10-03
• Primary completion: 2018-11-27
• Completion: 2018-11-27
• First posted: 2006-06-20
• Last updated: 2020-01-27
• Results posted: 2020-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study