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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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Atlanta, Georgia, 30322 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00417885
Pfizer
Terminated
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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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.
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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: exemestane
    25 mg, oral, daily dosing
  • Drug: sunitinib malate
    37.5 mg, oral, continuous dosing, daily
    Other Name: sutent
Experimental: A
sunitinib + exemestane
Interventions:
  • Drug: exemestane
  • Drug: sunitinib malate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
July 2009
July 2009   (Final data collection date for primary outcome measure)

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]
  • 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00417885
A6181108
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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