Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer

NCT00905021

Last updated date
Study Location
Baylor College of Medicine, Lester and Sue Smith Breast Center
Houston, Texas, 77030, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
Descriptive Information
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. 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  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
  • 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)
Study Arms  ICMJE 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.
Interventions:
  • Drug: Exemestane
  • Drug: Sutent
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
 (submitted: January 24, 2012)
4
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2009)
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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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
Plan to Share IPD:No
Responsible Party Mothaffar Rimawi, Baylor Breast Care Center
Study Sponsor  ICMJE Baylor Breast Care Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Mothaffar Rimiawi, MDBaylor College of Medicine
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