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

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suleiman Massarweh
• Collaborator: Bayer
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• 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

1. maximal response to endocrine therapy or

2. no response to endocrine therapy or

3. 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.

Exclusion Criteria:

• 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.