Adjuvant Doxorubicin/Cyclophosphamide and Paclitaxel Plus Sorafenib Breast Cancer

March 25, 2013 updated by: SCRI Development Innovations, LLC

A Pilot Study of Adjuvant Doxorubicin and Cyclophosphamide Followed by Paclitaxel Plus Sorafenib in Women With Node Positive or High-Risk Early Stage Breast Cancer

Sorafenib is being looked at in a number of solid tumor settings including breast cancer. This trial is designed as a pilot study to assess the safety and tolerability of a novel oral agent in combination with standard chemotherapy in the treatment of early stage node positive or otherwise high-risk breast cancer. If this should prove to be a tolerable regimen for patients, this would provide rationale for further studies in a larger randomized fashion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives The primary objective is to assess the safety and tolerability of doxorubicin / cyclophosphamide followed by paclitaxel in combination with sorafenib in patients with early stage node positive or otherwise high-risk breast cancer.

Secondary Objectives The secondary objectives are to assess activity in the form of recurrence-free-interval, distant recurrence-free interval,and overall survival in this pilot study of doxorubicin / cyclophosphamide followed by paclitaxel in combination with sorafenib in patients with early stage node positive or otherwise high-risk breast cancer.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Integrated Community Oncology Network
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Consultants in Blood Disorders and Cancer
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Grand Rapids Clinical Oncology Program
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology Hematology Associates
      • Nashville, Tennessee, United States, 37023
        • Tennessee Oncology, PLLC
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Peninsula Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients must have histologically-confirmed breast cancer with an interval between definitive surgery that includes axillary lymph node involvement assessment and initiation of study treatment of less than or equal to 84 days.
  • Definitive surgery - either mastectomy with axillary node involvement assessment, or breast conserving surgery with axillary node assessment. Margins of resected specimen must be free of invasive disease and/or ductal carcinoma in situ (DCIS).
  • Stage I, II, IIIA, and IIIC (T1-3, N3a only). Patients must be either lymph node positive or high-risk node negative.
  • Age > 18 years.
  • ECOG performance status 0 or 1.
  • Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) by Echocardiography or MUGA scan and electrocardiogram (ECG) within 35 days prior to initiation of study treatment.
  • Patients must have adequate bone marrow function
  • Patients must have normal liver function (
  • Serum creatinine <= 2mg/dl
  • INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored.

Exclusion Criteria:

  • Prior systemic anticancer therapy for breast cancer (immunotherapy, chemotherapy, hormonal therapy).
  • Patients with HER2 positive breast cancer as determined by FISH or IHC3+ standing are ineligible for this trial.
  • Prior anthracycline or taxane therapy.
  • Prior radiation therapy for breast cancer.
  • Bilateral invasive disease.
  • Pre-existing motor or sensory neurotoxicity of a severity ≥ 2 by NCI CTCAE v 3.0 criteria.
  • Cardiac disease that includes: myocardial infarction; angina, congestive heart failure, arrhythmia; valvular heart disease; cardiomegaly on chest imaging or ventricular hypertrophy on ECG - unless the LVEF is within normal range for the institution; patients with poorly controlled hypertension (defined as systolic blood pressure > 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications); patients who receive medications for angina, arrhythmias, or congestive heart failure.
  • Current therapy with raloxifene, tamoxifen or other selective estrogen receptor modulator
  • Concurrent treatment with ovarian hormonal replacement therapy.
  • History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ.
  • Women who are pregnant (positive pregnancy test) or breast feeding. Subjects of childbearing potential must use effective birth control measures during treatment.
  • Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.
  • Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
  • Thrombotic or embolic events such as a stroke and transient ischemic attack within the past 6 months.
  • Pulmonary hemorrhage/bleeding event ≥ NCI CTCAE v3.0 Grade 2 within 4 weeks of first dose of study drug.
  • Any other hemorrhage/bleeding event ≥ NCI CTCAE v3.0 Grade 3 within 4 weeks of first dose of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
Drug: Cyclophosphamide
Other Names:
  • Cytoxan
Drug: Doxorubicin
Other Names:
  • Adriamycin
Drug: Paclitaxel
Other Names:
  • Taxol
Drug: Sorafenib
Other Names:
  • Nexavar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0.
Time Frame: 18 Months
18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Bayer

Investigators

  • Study Chair: Denise Yardley, M.D., SCRI Development Innovations, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 15, 2007

First Submitted That Met QC Criteria

October 15, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

April 1, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRI BRE 112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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