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

This study has been terminated.
(See Detailed Description for Termination Reason)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00417885
First received: January 2, 2007
Last updated: September 16, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Drug: exemestane
Drug: sunitinib malate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) or death ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) ] [ Designated as safety issue: No ]
    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.

  • Duration of Response (DR) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer ] [ Designated as safety issue: No ]
    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.

  • Overall Survival (OS) [ Time Frame: From start of study treatment until death ] [ Designated as safety issue: No ]
    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.

  • Time to Tumor Progression (TTP) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) ] [ Designated as safety issue: No ]
    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.

  • Clinical Benefit Rate (CBR) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 6
Study Start Date: June 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
sunitinib + exemestane
Drug: exemestane
25 mg, oral, daily dosing
Drug: sunitinib malate
37.5 mg, oral, continuous dosing, daily
Other Name: sutent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417885

Locations
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3G 1A4
Pfizer Investigational Site
Montreal, Quebec, Canada, H3G 1L5
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00417885     History of Changes
Other Study ID Numbers: A6181108
Study First Received: January 2, 2007
Results First Received: July 9, 2010
Last Updated: September 16, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sunitinib
Exemestane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014