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EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Disease Progression in Weeks

Outcome Description:

Time from the first day of treatment to date of progression in weeks

Outcome 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

Safety Issue:

No

Principal Investigator

Mothaffar Rimiawi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Institutional Review Board

Study ID:

H 24786 / EXTENT

NCT ID:

NCT00905021

Start Date:

March 2010

Completion Date:

February 2012

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Cancer
  • Metastatic
  • Hormone Receptor Positive
  • Breast Neoplasms

Name

Location

Baylor College of Medicine, Lester and Sue Smith Breast CenterHouston, Texas  77030