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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

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: exemestane Drug: sunitinib malate Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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 Name: sutent



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00417885     History of Changes
Other Study ID Numbers: A6181108
First Posted: January 4, 2007    Key Record Dates
Results First Posted: August 30, 2010
Last Update Posted: September 21, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sunitinib
Exemestane
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists