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

Primary Purpose

Breast Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

sorafenib

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, Sorafenib, Nexavar, Endocrine Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Kentucky

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sorafenib & Endocrine Therapy

Arm Description

Sorafenib & Endocrine Therapy

Outcomes

Primary Outcome Measures

Response Rate

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.

Secondary Outcome Measures

Time to Progression

Clinical Benefit Rate

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.

Full Information

NCT ID

NCT00525161

First Posted

September 3, 2007

Last Updated

January 12, 2015

Sponsor

Suleiman Massarweh

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00525161

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual and loss of funding

Study Start Date

October 2007 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Suleiman Massarweh

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast cancer, Sorafenib, Nexavar, Endocrine Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sorafenib & Endocrine Therapy

Arm Type

Experimental

Arm Description

Sorafenib & Endocrine Therapy

Intervention Type

Drug

Intervention Name(s)

sorafenib

Other Intervention Name(s)

Nexavar

Intervention Description

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

Primary Outcome Measure Information:

Title

Response Rate

Description

Time Frame

12 weeks after treatment & 8 weeks after initial documentation of response

Secondary Outcome Measure Information:

Title

Time to Progression

Time Frame

continuously

Title

Clinical Benefit Rate

Description

Time Frame

24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suleiman Massarweh, MD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24826798

Citation

Massarweh S, Moss J, Wang C, Romond E, Slone S, Weiss H, Karabakhtsian RG, Napier D, Black EP. Impact of adding the multikinase inhibitor sorafenib to endocrine therapy in metastatic estrogen receptor-positive breast cancer. Future Oncol. 2014 Dec;10(15):2435-48. doi: 10.2217/fon.14.99.

Results Reference

result

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

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