A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer

Phase 1/2 Open-Label Trial Of Sutent (Sunitinib Malate) And Aromasin(Exemestane) In The First-Line Treatment Of Hormone Receptor-Positive Metastatic Breast Cancer

To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.

Study Overview

• Status: Terminated
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: exemestane; Drug: sunitinib malate

Detailed Description

The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3G 1L5
      • Pfizer Investigational Site
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• At least 18 years of age
• Estrogen and/or progesterone receptor positive adenocarcinoma of the breast with evidence of 1) unresectable 2)locally recurrent, or 3) metastatic disease
• Postmenopausal
• ECOG [Eastern Cooperative Oncology Group] </=1
• Evaluable(e.g bone only disease allowed) and Measurable disease [RECIST (Response Evaluation Criterion in Solid Tumors)]

Exclusion Criteria:

• HER2 [Human Epidermal Growth factor Receptor 2] positive disease not previously treated with herceptin
• Any prior anti-angiogenic therapy, endocrine or cytotoxic anti-cancer therapy in the metastatic disease setting
• Radiation therapy within 2 weeks of first study treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; sunitinib + exemestane	Drug: exemestane; 25 mg, oral, daily dosing; Drug: sunitinib malate; 37.5 mg, oral, continuous dosing, daily; Other Names: sutent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date - the date of enrollment +1)/7.	From start of treatment until Day 1 of every other cycle (8 weeks) or death

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)	OR=from start of treatment until disease progression/recurrence. Complete response (CR)=disappearance of all target lesions. Partial response (PR)= ? 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ? 20% increase in sum of longest dimensions of lesions taking as reference smallest sum of the longest dimensions since treatment started, or appearance of ? 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.	From start of treatment until Day 1 of every other cycle (8 weeks)
Duration of Response (DR)	DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death on study. If tumor progression data included more than 1 date, the first date was used. DR was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.	From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer
Overall Survival (OS)	OS was defined as the time from date of enrollment to date of death due to any cause. OS was to be calculated as (the event date - the date of enrollment +1)/7.	From start of study treatment until death
Time to Tumor Progression (TTP)	TTP was defined as the time from enrollment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was to be calculated as (first event date - the date of enrollment +1)/7.	From start of treatment until Day 1 of every other cycle (8 weeks)
Clinical Benefit Rate (CBR)	The clinical benefit rate (CBR) was the measure for clinical benefit (CB) and was defined as the percent of subjects with confirmed CR or confirmed PR, or confirmed SD according to RECIST, relative to the total analysis population. CRs were those that persisted on repeat imaging study ?4 weeks after initial documentation of response.	From start of treatment until Day 1 of every other cycle (8 weeks)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: January 2, 2007
• First Submitted That Met QC Criteria: January 2, 2007
• First Posted (Estimate): January 4, 2007

Study Record Updates

• Last Update Posted (Estimate): September 21, 2010
• Last Update Submitted That Met QC Criteria: September 16, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Sunitinib; Exemestane
• Other Study ID Numbers: A6181108