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

Primary Purpose

Metastatic Breast Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Exemestane

Sutent

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Breast Cancer, Metastatic, Hormone Receptor Positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Must have metastatic breast cancer or locally advanced not amenable to curative therapy.
Measurable or evaluable disease are eligible.
Tumors must be Estrogen Receptor (ER)-positive and/or Progesterone Receptor (PR)-positive.
Human Epidermal Growth Factor Recepter 2 (HER2)-positive tumors are allowed but must have failed Herceptin therapy.
Postmenopausal
No more than 3 lines of chemotherapy
No more than 3 lines of hormonal therapy
Bisphosphonates may be given according to their product license
Left ventricular ejection fraction within institutional normal limits
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.
Adequate blood counts
Normal thyroid function tests.
Patients with Central Nervous System (CNS) metastatic disease are allowed if the disease is stable for more than 3 months by CT or MRI.
Adequate general health (Eastern Cooperative Oncology Group (ECOG) performance status 0-2).
Able to give informed consent and follow the procedures of the study.

Exclusion Criteria:

Patients previously treated with exemestane in any setting.
Patients previously treated with sunitinib.
Patients with cardiac dysfunction or active cardiac disease
Patients with uncontrolled CNS metastasis.
Poorly controlled hypertension
Blood counts or liver and kidney tests that fall outside the ranges outlined in inclusion criteria 9-10 above.
ECOG performance status 3 or 4.
History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin.
History of a cerebrovascular accident, non-catheter related deep vein thrombosis, or pulmonary embolism in the last 5 years.
Major surgical procedure or significant traumatic injury within 28 days prior to study entry.
Premenopausal status.
History of receiving any investigational treatment within 28 days of study medication initiation.
Current known infection.
Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
Medical or psychiatric condition that in the opinion of the principal investigator impair their ability to participate in the study.

Sites / Locations

Baylor College of Medicine, Lester and Sue Smith Breast Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exemestane plus Sutent

Arm Description

All patients enrolled on the study will receive treatment as follows: Exemestane 25 mg by mouth every day. Sunitinib 37.5 mg by mouth every day.

Outcomes

Primary Outcome Measures

Time to Disease Progression in Weeks

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

Determine the Safety and Tolerability

Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells

Full Information

NCT ID

NCT00905021

First Posted

May 18, 2009

Last Updated

July 9, 2020

Sponsor

Baylor Breast Care Center

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00905021

Brief Title

Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer

Acronym

EXTENT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Terminated

Why Stopped

Sponsor withdrew support

Study Start Date

March 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baylor Breast Care Center

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: Obtain assessments of overall response rate (ORR), clinical benefit rate (CBR), and overall survival (OS). Determine the safety and tolerability of the combination regimen. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Breast Cancer

Keywords

Breast Cancer, Metastatic, Hormone Receptor Positive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exemestane plus Sutent

Arm Type

Experimental

Arm Description

All patients enrolled on the study will receive treatment as follows: Exemestane 25 mg by mouth every day. Sunitinib 37.5 mg by mouth every day.

Intervention Type

Drug

Intervention Name(s)

Exemestane

Other Intervention Name(s)

Aromasin

Intervention Description

Exemestane 25 mg by mouth every day.

Intervention Type

Drug

Intervention Name(s)

Sutent

Other Intervention Name(s)

(Sunitinib)

Intervention Description

Sunitinib 37.5 mg by mouth every day.

Primary Outcome Measure Information:

Title

Time to Disease Progression in Weeks

Description

Time from the first day of treatment to date of 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

Secondary Outcome Measure Information:

Title

Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival

Time Frame

5 years

Title

Determine the Safety and Tolerability

Time Frame

5 years

Title

Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must have metastatic breast cancer or locally advanced not amenable to curative therapy. Measurable or evaluable disease are eligible. Tumors must be Estrogen Receptor (ER)-positive and/or Progesterone Receptor (PR)-positive. Human Epidermal Growth Factor Recepter 2 (HER2)-positive tumors are allowed but must have failed Herceptin therapy. Postmenopausal No more than 3 lines of chemotherapy No more than 3 lines of hormonal therapy Bisphosphonates may be given according to their product license Left ventricular ejection fraction within institutional normal limits 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. Adequate blood counts Normal thyroid function tests. Patients with Central Nervous System (CNS) metastatic disease are allowed if the disease is stable for more than 3 months by CT or MRI. Adequate general health (Eastern Cooperative Oncology Group (ECOG) performance status 0-2). Able to give informed consent and follow the procedures of the study. Exclusion Criteria: Patients previously treated with exemestane in any setting. Patients previously treated with sunitinib. Patients with cardiac dysfunction or active cardiac disease Patients with uncontrolled CNS metastasis. Poorly controlled hypertension Blood counts or liver and kidney tests that fall outside the ranges outlined in inclusion criteria 9-10 above. ECOG performance status 3 or 4. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin. History of a cerebrovascular accident, non-catheter related deep vein thrombosis, or pulmonary embolism in the last 5 years. Major surgical procedure or significant traumatic injury within 28 days prior to study entry. Premenopausal status. History of receiving any investigational treatment within 28 days of study medication initiation. Current known infection. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures). Medical or psychiatric condition that in the opinion of the principal investigator impair their ability to participate in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mothaffar Rimiawi, MD

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baylor College of Medicine, Lester and Sue Smith Breast Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer

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