Clinical trial · Interventional
Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer
EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer
NCT00905021CI-TRIAL-00046141EXTENTterminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor withdrew support
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exemestane | Drug | Exemestane | ALIAS |
| Sutent | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exemestane plus Sutent
- description
- All patients enrolled on the study will receive treatment as follows: 1. Exemestane 25 mg by mouth every day. 2. Sunitinib 37.5 mg by mouth every day.
- interventionNames
- Drug: Exemestane
- Drug: Sutent
Primary outcomes (1)
- measure
- Time to Disease Progression in Weeks
- timeFrame
- Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance
- description
- Time from the first day of treatment to date of progression in weeks
Secondary outcomes (3)
- measure
- Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.