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

Pfizer

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Breast Neoplasms

Treatments: Drug: exemestane; Drug: sunitinib malate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00417885

A6181108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

A

Experimental group

Description:

sunitinib + exemestane

Treatment:

Drug: sunitinib malate

Drug: exemestane