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Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer (EXTENT)

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ClinicalTrials.gov Identifier: NCT00905021
Recruitment Status : Terminated (Sponsor withdrew support)
First Posted : May 20, 2009
Results First Posted : May 28, 2012
Last Update Posted : March 14, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Exemestane Drug: Sutent Phase 1 Phase 2

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. Obtain assessments of overall response rate (ORR), clinical benefit rate (CBR), and overall survival (OS).
  2. Determine the safety and tolerability of the combination regimen.
  3. Study molecular changes in tissue biopsies, circulating tumor cells (CTCs), and circulating endothelial cells (CECs), and explore associations with treatment response and resistance.

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 : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer
Study Start Date : March 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Exemestane plus Sutent

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.
Drug: Exemestane
Exemestane 25 mg by mouth every day.
Other Name: Aromasin
Drug: Sutent
Sunitinib 37.5 mg by mouth every day.
Other Name: (Sunitinib)



Primary Outcome Measures :
  1. Time to Disease Progression in Weeks [ Time Frame: 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 ]
    Time from the first day of treatment to date of progression in weeks


Secondary Outcome Measures :
  1. Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival [ Time Frame: 5 years ]
  2. Determine the Safety and Tolerability [ Time Frame: 5 years ]
  3. Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905021


Locations
United States, Texas
Baylor College of Medicine, Lester and Sue Smith Breast Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor Breast Care Center
Pfizer
Investigators
Principal Investigator: Mothaffar Rimiawi, MD Baylor College of Medicine

Responsible Party: Mothaffar Rimawi, Medical Director, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00905021     History of Changes
Other Study ID Numbers: H 24786 / EXTENT
First Posted: May 20, 2009    Key Record Dates
Results First Posted: May 28, 2012
Last Update Posted: March 14, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mothaffar Rimawi, Baylor Breast Care Center:
Breast Cancer
Metastatic
Hormone Receptor Positive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sunitinib
Exemestane
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists