Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

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

sorafenib

Suleiman Massarweh, MD

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.

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.

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

A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.

Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks.

Bayer

Suleiman Massarweh

Clinical Faculty, Internal Medicine / Oncology

Sorafenib \& Endocrine Therapy

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

Sorafenib & Endocrine Therapy

Age, Continuous

<40 years

40-49 years

50-59 years

60-69 years

>=70 years

Age, Customized

Sex: Female, Male

Locally advanced

de novo

Relapsed

Relapsed versus de novo metastasis

Positive

Negative

Estrogen receptor status

Progesterone receptor status

Unknown

Human epidermal growth factor receptor 2 (HER2) status

Tamoxifen

Anastrozole

Exemestane

Fulvestrant

Letrozole

Endocrine therapy at study entry

First-line (Primary) treatment

Second-line (Subsequent) treatment

Line of current endocrine therapy

Progressive Disease

Stable disease with maximal response

Disease status at entry

Prior chemotherapy

Bone metastases

Lung Metastases

Early termination of study due to slow accrual.

Dr. Suleiman Massarweh

Based on known historical response rate to sorafenib of no better than 5-10%, the study was designed to test the null hypothesis that the clinical response rate is no better than 10% versus the alternative hypothesis that it is at least 25% when sorafenib is added to endocrine therapy. In the first stage, 18 patients were planned for enrollment, and if two or fewer responses were observed, the trial would be terminated. The study stopped after 11 due to slow accrual and withdrawal of funding.

Stable Disease

Progression

one discontinued treatment after 2 weeks owing to a grade 3 rash and was not evaluable for response

Response Rate

Time to Progression

Clinical Benefit Rate

Overall Study

Spots Global Cancer Trial Database for Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

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