- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00407888
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
Adjuvant Therapy for High-Risk Localized Breast Cancer Using Weekly Adriamycin + Daily Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Abraxane™ for 12 Weeks With Concurrent Herceptin for Subjects With HER-2/Neu Positive Disease, Phase II
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 tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy and filgrastim together with trastuzumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel albumin-stabilized nanoparticle formulation and trastuzumab works in treating patients with breast cancer previously treated with surgery
Study Overview
Status
Conditions
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 if appropriate for adjuvant treatment of high risk breast cancer patients.
SECONDARY OBJECTIVES:
I. To assess the toxicity associated with this regimen. II. To assess the delivered dose intensity of the regimen. III. To assess time to treatment failure and overall survival of the regimen. IV. To assess the incidence and severity of delayed nausea and vomiting with this regimen.
OUTLINE:
Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
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: Arm I
Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7.
Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Ancillary studies
Other Names:
Given IV
Other Names:
Given SC
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delivered Dose Intensity of the Regimen
Time Frame: After at least one course of Adriamycin, up to 12 weeks.
|
After at least one course of Adriamycin, up to 12 weeks.
|
|
Toxicity Associated With This Regimen
Time Frame: After at least one course of Adriamycin, up to 12 weeks.
|
After at least one course of Adriamycin, up to 12 weeks.
|
|
Time to Treatment Failure
Time Frame: Up to 6 years
|
Median time from date of start of therapy to date of removal from therapy for reason other than completion, date of first observation of recurrent disease or date of death due to any cause whichever comes first.
|
Up to 6 years
|
Overall Survival
Time Frame: Up to 6 years.
|
Count of surviving patients at two years and six years
|
Up to 6 years.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vijayakrishna K Gadi, MDPHD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Paclitaxel
- Trastuzumab
- Albumin-Bound Paclitaxel
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- 6141
- NCI-2010-02117 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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.
Clinical Trials on HER2-positive Breast Cancer
-
Mersana TherapeuticsRecruitingHER2-positive Breast Cancer | HER2-positive Gastric Cancer | HER2-positive Non-Small Cell Lung Cancer | HER2-positive Colorectal Cancer | HER2-positive Tumors | HER2 Low Breast CancerUnited States
-
QuantumLeap Healthcare CollaborativeRecruitingSolid Tumor | Metastatic Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | HER2-positive Breast Cancer | Solid Tumor, Adult | Solid Carcinoma | HER2-positive Metastatic Breast Cancer | Progesterone Receptor-positive Breast Cancer | HER2-negative Breast Cancer | Estrogen Receptor Positive... and other conditionsUnited States
-
MacroGenicsApproved for marketingHER2-positive Breast Cancer | HER2-positive Carcinoma
-
Spanish Breast Cancer Research GroupSeagen Inc.RecruitingHER2-positive Metastatic Breast Cancer | Locally Advanced HER2 Positive Breast CarcinomaSpain
-
Cancer Trials IrelandCompletedBreast Cancer | HER2 Positive Breast Cancer | HER2 Negative Breast CancerIreland
-
Enliven TherapeuticsRecruitingColorectal Cancer | HER2-positive Breast Cancer | HER2-positive Gastric Cancer | HER2 Amplification | HER2 Positive Solid TumorsUnited States
-
Daiichi SankyoRecruitingBreast Cancer | Advanced Cancer | HER2-positive Breast Cancer | HER2-low Breast CancerChina
-
University of ArizonaPfizerCompletedBreast Cancer | Metastatic Breast Cancer | HER2-positive Breast Cancer | Recurrent Breast Cancer | HER2 Positive Breast Carcinoma | Breast Cancer StageUnited States
-
Clovis Oncology, Inc.TerminatedBreast Cancer | Metastatic Breast Cancer | Estrogen Receptor Positive | Triple Negative | HER2 | HER2 Positive | MBC | ERUnited States
-
Masonic Cancer Center, University of MinnesotaActive, not recruitingTriple Negative Breast Cancer | HER2-positive Breast Cancer | TN ER-/PR-/HER2- Breast Cancer | ERany/PRany/HER2+ Breast CancerUnited States
Clinical Trials on laboratory biomarker analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States