Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer

NCT00905021 | Terminated Phase 1 Results DMC

• 1 other identifier: H 24786 / EXTENT
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

Breast Cancer; Metastatic; Hormone Receptor Positive

Outcome Measures

Primary Outcomes (1)

• Time to Disease Progression in Weeks

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

  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 Outcomes (3)

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

  5 years

• Determine the Safety and Tolerability

  5 years

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

  5 years

Study Arms (1)

Exemestane plus Sutent

EXPERIMENTAL

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; Drug: Sutent

Interventions

Exemestane DRUG

Exemestane 25 mg by mouth every day.

Also known as: Aromasin

Exemestane plus Sutent

Sutent DRUG

Sunitinib 37.5 mg by mouth every day.

Also known as: (Sunitinib)

Exemestane plus Sutent

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Baylor Breast Care Center: lead
• Pfizer: collaborator

Study Sites (1)

Baylor College of Medicine, Lester and Sue Smith Breast Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

exemestane; Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Mothaffar Rimawi
• Organization: Baylor College of Medicine

rimawi@bcm.edu

713-798-1311

Study Officials

• Mothaffar Rimiawi, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: March 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2012
• Last Updated: July 24, 2020
• Results First Posted: May 28, 2012

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)