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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival following a dose-intensive weekly regimen of Adriamycin + oral cyclophosphamide augmented with G-CSF support followed by Abraxane and Herceptin

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Georgiana Ellis

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

6141

NCT ID:

NCT00407888

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Estrogen Receptor-positive Breast Cancer
  • HER2-positive Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109