Status:
COMPLETED
Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Male Breast Carcinoma
Stage IIA Breast Cancer AJCC v6 and v7
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer tha...
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether adding bevacizumab to neoadjuvant weekly paclitaxel (+/- carboplatin) and subsequent dose-dense doxorubicin and cyclophosphamide (ddAC) significantly raise...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Invasive breast cancer, diagnosed by core needle or incisional biopsy (excisional biopsy not permitted)
- The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor (ER) and progesterone receptor (PgR) negative or staining present in =\< 10% of invasive cancer cells by immunohistochemistry (IHC)
- The invasive tumor must be HER2-negative, defined as IHC 0-1+ or with a fluorescent in situ hybridization (FISH) ratio (HER2 gene copy/chromosome 17) of \< 2.0 if IHC 2+
- Clinical stage II-III invasive breast cancer with intent to perform surgical resection after neoadjuvant therapy; patients with inflammatory breast cancer are not eligible; staging to rule out metastatic disease is recommended for clinical stage III patients
- Patients with multicentric or bilateral disease are eligible if the target lesion meets eligibility criteria
- Patient agrees to undergo pretreatment research biopsies
- No prior chemotherapy, hormone therapy, or radiation therapy with therapeutic intent for this cancer
- The target lesion in the breast must be \>= 1 cm, clinically or radiographically; palpable or radiographically measurable axillary adenopathy will be recorded but will not serve as measurable disease for the primary endpoint; patients with axillary disease only (no identifiable tumor in the breast that is \>= 1 cm on physical exam or radiographic study) are not eligible to participate
- Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or lower gastrointestinal \[GI\] bleeding) within 6 months of registration are not eligible
- No serious or non-healing wound, skin ulcers or bone fracture; no abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the past 6 months; no major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of study
- The following are not considered to be major surgical procedures that would be prohibited in the 28 days prior to, or following study randomization: obtaining the required research needle biopsies; placement of a radiopaque clip to localize a tumor or tumors for subsequent surgical resection; placement of a port for central venous access; fine needle aspiration of a prominent or suspicious axillary lymph node; needle biopsy of a clinically or radiographically detected lesion to rule out metastatic disease; or pretreatment sentinel lymph node sampling
- No baseline neuropathy grade \>= 2
- Zubrod performance status 0-1
- Pregnant or nursing women are not eligible; all women of reproductive potential must have a negative pregnancy test at baseline and agree to use an effective, non-hormonal method of contraception during the entire period of treatment on the study
- Patients with congestive heart failure are not eligible, nor are patients with myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack (TIA) within the past 12 months, uncontrolled hypertension (systolic blood pressure \[SBP\] \> 160 or diastolic blood pressure \[DBP\] \> 90), uncontrolled or symptomatic arrhythmia, or grade II or greater peripheral vascular disease
- Patients must have a pretreatment multi gated acquisition (MUGA) scan or echocardiogram with a left ventricular ejection fraction (LVEF) above the institutional lower limit of normal
- Granulocytes \> 1,000/mcl
- Platelets \> 100,000/mcl
- Total bilirubin =\< 1.5 x upper limits of normal
- Calculated or measured \> 30 ml/min
- Urine protein =\< 1+ or urine protein to creatinine (UPC) ratio \< 1
- Patients discovered to have \>= 2+ proteinuria at baseline must undergo a 24-hour urine collection that must demonstrate \< 1 g of protein/24 hr, or UPC ratio \< 1 to allow participation in the study
- Serum alanine aminotransferase (ALT) =\< 2.5 x upper limits of normal
- Serum beta human chorionic gonadotropin (HCG) negative (for women of child bearing potential)
- Prothrombin time (PT)/international normalized ratio (INR) =\< 1.5 x upper limit of normal (ULN)
- Unless patient is on therapeutic doses of warfarin; if so, the patient must have an INR =\< 3 on a stable dose of warfarin, must have not active bleeding or pathologic condition that is associated with a high risk of bleeding
Exclusion
Key Trial Info
Start Date :
July 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2025
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT00861705
Start Date
July 21 2009
End Date
September 2 2025
Last Update
September 30 2025
Active Locations (448)
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1
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States, 72401
2
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States, 72401
3
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States, 72758
4
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704