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

This study has been terminated.
(Sponsor withdrew support)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00905021
First received: May 18, 2009
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
Drug: Exemestane
Drug: Sutent (Sunitinib)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Time from the first day of treatment to date of progression in weeks


Secondary Outcome Measures:
  • Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Determine the Safety and Tolerability [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: March 2010
Study Completion Date: February 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Aromasin (Exemestane)
  • Sutent (Sunitinib)
Drug: Sutent (Sunitinib)
Sunitinib 37.5 mg by mouth every day.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mothaffar Rimawi, Medical Director, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00905021     History of Changes
Other Study ID Numbers: H 24786 / EXTENT
Study First Received: May 18, 2009
Results First Received: February 6, 2012
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014