Adjuvant Doxorubicin/Cyclophosphamide and Paclitaxel Plus Sorafenib Breast Cancer

NCT00544167 | Completed Results

• 1 other identifier: SCRI BRE 112
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  18 Months

Study Arms (1)

Intervention

EXPERIMENTAL

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: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel; Drug: Sorafenib

Interventions

Doxorubicin DRUG

Also known as: Adriamycin

Intervention

Cyclophosphamide DRUG

Also known as: Cytoxan

Intervention

Paclitaxel DRUG

Also known as: Taxol

Intervention

Sorafenib DRUG

Also known as: Nexavar

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Bayer: collaborator

Study Sites (8)

Integrated Community Oncology Network

Jacksonville, Florida, 32256, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

Related Publications (1)

• Spigel DR, Hainsworth JD, Burris HA 3rd, Molthrop DC, Peacock N, Kommor M, Vazquez ER, Greco FA, Yardley DA. A pilot study of adjuvant doxorubicin and cyclophosphamide followed by paclitaxel and sorafenib in women with node-positive or high-risk early-stage breast cancer. Clin Adv Hematol Oncol. 2011 Apr;9(4):280-6.

  PMID: 21558987 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; Cyclophosphamide; Paclitaxel; Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: John Hainsworth, MD
• Organization: Sarah Cannon Research Institute

ASKSARAH@scresearch.net

877-691-7274

Study Officials

• Denise Yardley, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 16, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2011
• Last Updated: April 1, 2013
• Results First Posted: January 25, 2013

Record last verified: 2013-03

Locations

US (8)