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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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A pilot Phase II study adding sorafenib to endocrine therapy in 11 patients with metastatic estrogen receptor-positive breast cancer was conducted. Primary end point was response by Response Evaluation Criteria in Solid Tumors (RECIST) after 3 months of sorafenib. Secondary end points included safety, time to progression and biomarker modulation. The study closed early owing to slow accrual.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sorafenib & Endocrine Therapy

Sorafenib \& Endocrine Therapy

Group Type EXPERIMENTAL

sorafenib

Intervention Type DRUG

400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.

Interventions

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sorafenib

400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.

Intervention Type DRUG

Other Intervention Names

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Nexavar

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No