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NCT00861705

PHASE2

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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 that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Official title: Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

454

Start Date

2009-07-21

Completion Date

2025-09-02

Last Updated

2026-06-29

Healthy Volunteers

Conditions

Male Breast Carcinoma Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage IIIA Breast Cancer AJCC v7 Triple-Negative Breast Carcinoma

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Carboplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

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

Locations (448)

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, United States

Highlands Oncology Group - Rogers

Rogers, Arkansas, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

East Bay Radiation Oncology Center

Castro Valley, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

El Camino Hospital

Mountain View, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Wilma Chan Highland Hospital

Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Tom K Lee Inc

Oakland, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Valley Medical Oncology Consultants

Pleasanton, California, United States

Salinas Valley Memorial

Salinas, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

Breastlink Medical Group Inc

Santa Ana, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Western States Cancer Research NCORP

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Banner McKee Medical Center

Loveland, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Hartford HealthCare - Saint Vincent's Medical Center

Bridgeport, Connecticut, United States

Greenwich Hospital

Greenwich, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Manchester Memorial Hospital

Manchester, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Cancer Center of South Florida-Lake Worth

Lake Worth, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Piedmont Hospital

Atlanta, Georgia, United States

Atlanta Regional CCOP

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

WellStar Cobb Hospital

Austell, Georgia, United States

John B Amos Cancer Center

Columbus, Georgia, United States

Emory Decatur Hospital

Decatur, Georgia, United States

Piedmont Fayette Hospital

Fayetteville, Georgia, United States

Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, United States

Northside Hospital - Gwinnett

Lawrenceville, Georgia, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Southern Regional Medical Center

Riverdale, Georgia, United States

Harbin Clinic Medical Oncology and Clinical Research

Rome, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza