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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms

Intervention: exemestane (Drug); sunitinib malate (Drug)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression Free Survival (PFS)

Secondary outcome:

Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)

Duration of Response (DR)

Overall Survival (OS)

Time to Tumor Progression (TTP)

Clinical Benefit Rate (CBR)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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]

- 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

Locations and Contacts

Pfizer Investigational Site, Atlanta, Georgia 30322, United States

Pfizer Investigational Site, Montreal, Quebec H3G 1A4, Canada

Pfizer Investigational Site, Montreal, Quebec H3G 1L5, Canada

Additional Information

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

Starting date: June 2007
Last updated: September 16, 2010

Page last updated: August 20, 2015

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