Status:
COMPLETED
Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Estrogen Receptor-negative Breast Cancer
Estrogen Receptor-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast can...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the pathologic response rate in patients with operable breast cancer treated with a two part, neoadjuvant regimen consisting of weekly doxorubicin (doxorubicin hydroc...
Eligibility Criteria
Inclusion
- Have known tumor HER-2/neu expression; if determination is "intermediate" by immunohistochemistry, fluorescent in situ hybridization (FISH) must be performed; protocol therapy is determined by HER-2/neu result
- Have histologically confirmed, operable breast cancer that is either:
- Hormone receptor (estrogen receptor \[ER\] or progesterone receptor \[PR\]) positive and HER2/neu positive or
- ER/PR negative
- Have radiographically measurable breast cancer \> 1cm (Operable lesions are T1c-T3 and N0-N2a; histologic confirmation should be by core needle biopsy only)
- Be chemotherapy naïve
- Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
- Absolute neutrophil count (ANC) \>= 1,500
- Platelet count \>= 100,000
- Serum creatinine =\< 1.5 x international upper limit of normal (IULN)
- Bilirubin \< 2.0
- Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) =\< 2 x IULN
- Alkaline phosphatase =\< 2 x IULN
- Have staging studies and tumor assessment prior to registration; staging studies include physical exam with bidimensional tumor measurements and mammography, ultrasound, or magnetic resonance imaging (MRI) to assess tumor volume; sentinel lymph node dissection or axillary needle biopsy must be completed prior to enrollment; MRI and positron emission tomography (PET) (fluorodeoxyglucose \[FDG\], methoxyisobutylisonitrile \[MIBI\] and fluoroestradiol \[FES\]) imaging will be done before enrollment if clinically indicated to assess tumor volume or may be done within the first month of study participation on another institutional protocol
- 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 multi gated acquisition scan (MUGA) prior to enrollment; patients with breast cancer that is HER-2/neu positive who will receive herceptin (trastuzumab) must have an echocardiogram or MUGA scan; the left ventricular ejection fraction (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
- Women of childbearing potential must have a negative pregnancy test within seven days prior to registration
- 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
- Primary tumor =\< 1 cm, not measurable; inflammatory disease
- Pregnant or lactating; woman of childbearing potential with either a positive or no pregnancy test at baseline are excluded; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; patients must agree to continue contraception for 30 days from the date of the last study drug administration; woman of childbearing potential not using a reliable and appropriate contraceptive method are excluded
- Evidence of distant metastatic disease
- Prior chemotherapy or hormonal therapy for breast cancer
- 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 situ cervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil
- Previous enrollment in an investigational drug study within the past four weeks
- History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance with oral drug intake
- Patients with cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin are not eligible
- Active cardiac disease:
- 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 electrocardiogram (EKG)
- Uncontrolled hypertension, (diastolic greater than 100 mm/Hg or systolic \> 200 mm/hg)
- Current use of digitalis or beta blockers for congestive heart failure (CHF)
- Clinically significant pericardial effusion
- History of cardiac disease:
- 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
- Major surgery within 4 weeks of the start of study treatment without complete recovery
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- Known, existing uncontrolled coagulopathy
- Unwillingness to give written informed consent
- Unwillingness to participate or inability to comply with the protocol for the duration of the study
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00194779
Start Date
October 1 2003
End Date
June 1 2011
Last Update
March 12 2018
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109