Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators want to find out if the treatments used in this study are helpful to patients that are diagnosed with hormone receptor positive metastatic breast cancer. The investigators want to also look at any side effects that could happen while patients are on the study treatments. The investigators want to see if there are any changes that could show us if your cancer is responding to the study treatments.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Breast Care Center
• Collaborator: Pfizer
• Treatments: Exemestane; Sunitinib

Criteria

Inclusion Criteria:

1. Must have metastatic breast cancer or locally advanced not amenable to curative therapy.

2. Measurable or evaluable disease are eligible.

3. Tumors must be Estrogen Receptor (ER)-positive and/or Progesterone Receptor (PR)-positive.

4. Human Epidermal Growth Factor Recepter 2 (HER2)-positive tumors are allowed but must have failed Herceptin therapy.

5. Postmenopausal

6. No more than 3 lines of chemotherapy

7. No more than 3 lines of hormonal therapy

8. Bisphosphonates may be given according to their product license

9. Left ventricular ejection fraction within institutional normal limits

10. Liver function and kidney function tests within the upper limit of normal. In patients with liver metastasis, liver function tests should be < 5 times the upper limit of normal.

11. Adequate blood counts

12. Normal thyroid function tests.

13. Patients with Central Nervous System (CNS) metastatic disease are allowed if the disease is stable for more than 3 months by CT or MRI.

14. Adequate general health (Eastern Cooperative Oncology Group (ECOG) performance status 0-2).

15. Able to give informed consent and follow the procedures of the study.

Exclusion Criteria:

1. Patients previously treated with exemestane in any setting.

2. Patients previously treated with sunitinib.

3. Patients with cardiac dysfunction or active cardiac disease

4. Patients with uncontrolled CNS metastasis.

5. Poorly controlled hypertension

6. Blood counts or liver and kidney tests that fall outside the ranges outlined in inclusion criteria 9-10 above.

7. ECOG performance status 3 or 4.

8. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin.

9. History of a cerebrovascular accident, non-catheter related deep vein thrombosis, or pulmonary embolism in the last 5 years.

10. Major surgical procedure or significant traumatic injury within 28 days prior to study entry.

11. Premenopausal status.

12. History of receiving any investigational treatment within 28 days of study medication initiation.

13. Current known infection.

14. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).

15. Medical or psychiatric condition that in the opinion of the principal investigator impair their ability to participate in the study.