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Trial record 1 of 1 for:    NCT00417885
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A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer

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ClinicalTrials.gov Identifier: NCT00417885
Recruitment Status : Terminated (See Detailed Description for Termination Reason)
First Posted : January 4, 2007
Results First Posted : August 30, 2010
Last Update Posted : September 21, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 2, 2007
First Posted Date  ICMJE January 4, 2007
Results First Submitted Date  ICMJE July 9, 2010
Results First Posted Date  ICMJE August 30, 2010
Last Update Posted Date September 21, 2010
Study Start Date  ICMJE June 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
Progression Free Survival (PFS) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) or death ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2007)
Progression-free survival assessing the combination of Sunitinib with Exemestane in patients with hormone receptor-positive metastatic breast cancer
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2010)
  • 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) ]
    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 ]
    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 ]
    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) ]
    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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2007)
  • Response Rate
  • Overall Survival
  • Pharmacokinetics
  • Safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: exemestane
    25 mg, oral, daily dosing
  • Drug: sunitinib malate
    37.5 mg, oral, continuous dosing, daily
    Other Name: sutent
Study Arms  ICMJE Experimental: A
sunitinib + exemestane
Interventions:
  • Drug: exemestane
  • Drug: sunitinib malate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 18, 2008)
6
Original Enrollment  ICMJE
 (submitted: January 2, 2007)
72
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00417885
Other Study ID Numbers  ICMJE A6181108
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP