Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.

Key facts

Study ID

NCT00525161

Run by

Suleiman Massarweh

People needed

11

Starts

2007-10-01

Expected to finish

2015-01-01

Last updated by the study team

2015-01-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• All subjects must be female.
• Age ≥ 18 years old.
• Histologically proven carcinoma of the breast.
• Estrogen receptor and/or Progesterone positive disease.
• Metastatic or locally advanced disease.
• Patients on a preexisting endocrine agent for at least 3 months before enrollment.
• Have residual measurable disease after
• maximal response to endocrine therapy or
• no response to endocrine therapy or
• progressive non-visceral disease on endocrine therapy.
• Must be able to provide a tumor block from either the primary or metastatic site, if available.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
• Adequate organ function.

You may not qualify if…

• Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy.
• Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ.
• Prior use of anti-angiogenic agents.
• As judged by the investigator, uncontrolled intercurrent illness.
• Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
• Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
• Known or suspected allergy to sorafenib or any agent given in the course of this trial.
• A serious non-healing wound or ulcer.
• Evidence or history of bleeding diathesis or coagulopathy.
• Major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug.
• Pulmonary hemorrhage/bleeding event ≥ Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within the 4 weeks prior to the first dose of study drug.
• Pregnancy
• Any condition that impairs patient's ability to swallow whole pills.
• Documented malabsorption problem.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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