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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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

18 Months

Safety Issue:

Yes

Principal Investigator

Denise Yardley, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI BRE 112

NCT ID:

NCT00544167

Start Date:

May 2007

Completion Date:

April 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Early Stage
  • High Risk
  • Node Positive
  • Doxorubicin
  • Cyclophosphamide
  • Paclitaxel
  • Sorafenib
  • Breast Neoplasms

Name

Location

Florida Hospital Cancer Institute Orlando, Florida  32804
Consultants in Blood Disorders and Cancer Louisville, Kentucky  40207
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Methodist Cancer Center Omaha, Nebraska  68114
Peninsula Cancer Institute Newport News, Virginia  23601
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404