Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer
NCT00905021
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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.
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Descriptive Information | ||||
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Brief Title ICMJE | Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer | |||
Official Title ICMJE | EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer | |||
Brief 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. | |||
Detailed Description | The study design is a phase II design. Eligible patients will undergo staging work up and start treatment. Every 28-day period (4 weeks) will count as a cycle. Medical evaluations will be performed every 4 weeks and staging work up will be repeated every 12 weeks. The primary objective of the study is to assess progression free survival (PFS) of treatment with exemestane and sunitinib in post¬menopausal subjects with hormone receptor positive (ER-positive and/or PR-positive) unresectable locally advanced or metastatic breast cancer subjects who have progressed on prior hormonal treatment. In addition we want to:
1. Blood samples will be drawn for enumeration and profiling of circulating tumor cells and circulating endothelial cells at study entry (prior to starting study medications), four weeks after starting study medications, twelve weeks after starting study medications and at disease progression. These samples will be strongly encouraged but the patients may decline any or all of them without impacting their eligibility or continuation on the study. 2. If the patient participating on the study has an easily accessible breast mass or metastatic lesion (e.g. lymphadenopathy, skin metastasis, chest wall metastasis), a core needle or punch biopsy will be obtained at study entry (prior to starting study medications), four weeks after starting study medications, and at disease progression. These biopsies will be strongly encouraged but the patients may decline any or all of them without impacting their eligibility or continuation on the study. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Metastatic Breast Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Exemestane plus Sutent
All patients enrolled on the study will receive treatment as follows:
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 4 | |||
Original Estimated Enrollment ICMJE | 51 | |||
Actual Study Completion Date ICMJE | February 2012 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00905021 | |||
Other Study ID Numbers ICMJE | H 24786 / EXTENT | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
| |||
Responsible Party | Mothaffar Rimawi, Baylor Breast Care Center | |||
Study Sponsor ICMJE | Baylor Breast Care Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Baylor Breast Care Center | |||
Verification Date | July 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |