Status:
COMPLETED
Doxorubicin Hydrochloride, Cyclophosphamide, and Filgrastim Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Trastuzumab in Treating Patients With Breast Cancer Previously Treated With Surgery
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Estrogen Receptor-positive Breast Cancer
HER2-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tum...
Detailed Description
PRIMARY OBJECTIVES: I. To assess disease-free survival following a dose-intensive weekly regimen of Adriamycin + oral cyclophosphamide augmented with G-CSF support followed by Abraxane and Herceptin ...
Eligibility Criteria
Inclusion
- Have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected; (this regimen is not intended for neoadjuvant treatment)
- 4 + nodes
- OR if 1-3 + nodes, either ER OR HER-2/neu+
- OR have high-risk node negative disease that is HER-2/neu positive OR \>= 2.0 cm tumor size
- HER-2/new + definition: patient has known tumor HER-2/new expression = 3+ by IHC or, if 2+ by IHC confirmed to be FISH positive
- Patients with clinically apparent cardiac disease, or history of same, are not eligible; patients who are \>= 60 years of age or who have a history of hypertension must have an echocardiogram or MUGA prior to enrollment; patients with breast cancer that is HER-2/neu positive and a treatment plan that includes Herceptin must have an echocardiogram or MUGA scan prior to enrollment; the LVEF must be within the institutional normal range; if LVEF is \> 75%, the investigator should consider having the LVEF reviewed or repeating the MUGA prior to registration
- WBC \>= 4,000
- ANC \>= 1,500
- Platelet count \>= 100,000
- Serum creatinine =\< 1.5 x IULN
- Bilirubin =\< 2.0
- SGOT/SGPT/alkaline phosphatase =\< 2 x IULN
- Elevations greater than these require metastatic work up
- Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
Exclusion
- Except for the following, no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situcervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years
- Patients with cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin are not eligible; this includes:
- Angina pectoris that requires the use of antianginal medication
- Cardiac arrhythmia requiring medication
- Severe conduction abnormality
- Clinically significant valvular disease
- Cardiomegaly on chest x-ray
- Ventricular hypertrophy on EKG
- Uncontrolled hypertension, (diastolic greater than 100 mm/Hg or systolic \> 200 mm/hg)
- Current use of digitalis or beta blockers for CHF
- Clinically significant pericardial effusion
- Myocardial infarction documented as a clinical diagnosis or by EKG or any other test
- Documented congestive heart failure
- Documented cardiomyopathy
- Documented arrhythmia or cardiac valvular disease that requires medication or is medically significant
- Patients who have received prior chemotherapy or radiotherapy are not eligible
- Patients who are pregnant or breastfeeding are not eligible; women of child bearing potential must agree to practice adequate contraception
- Patients with active infection are not eligible
- Patients who are known to be infected with HIV, hepatitis B or hepatitis C are not eligible; testing is not required unless there is a high index of clinical suspicion
- Patients suffering from psychiatric impairment are not eligible
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00407888
Start Date
May 1 2006
End Date
July 1 2012
Last Update
August 31 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109