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

Phase 2

Active, not recruiting

• 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

• Registration Number: NCT00861705
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-3-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Invasive breast cancer, diagnosed by core needle or incisional biopsy (excisional<br> biopsy not permitted)<br><br> - The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor<br> (ER) and progesterone receptor (PgR) negative or staining present in =< 10% of<br> invasive cancer cells by immunohistochemistry (IHC)<br><br> - The invasive tumor must be HER2-negative, defined as IHC 0-1+ or with a fluorescent<br> in situ hybridization (FISH) ratio (HER2 gene copy/chromosome 17) of < 2.0 if IHC 2+<br><br> - Clinical stage II-III invasive breast cancer with intent to perform surgical<br> resection after neoadjuvant therapy; patients with inflammatory breast cancer are<br> not eligible; staging to rule out metastatic disease is recommended for clinical<br> stage III patients<br><br> - Patients with multicentric or bilateral disease are eligible if the target lesion<br> meets eligibility criteria<br><br> - Patient agrees to undergo pretreatment research biopsies<br><br> - No prior chemotherapy, hormone therapy, or radiation therapy with therapeutic intent<br> for this cancer<br><br> - The target lesion in the breast must be >= 1 cm, clinically or radiographically;<br> palpable or radiographically measurable axillary adenopathy will be recorded but<br> will not serve as measurable disease for the primary endpoint; patients with<br> axillary disease only (no identifiable tumor in the breast that is >= 1 cm on<br> physical exam or radiographic study) are not eligible to participate<br><br> - Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or<br> lower gastrointestinal [GI] bleeding) within 6 months of registration are not<br> eligible<br><br> - No serious or non-healing wound, skin ulcers or bone fracture; no abdominal fistula,<br> gastrointestinal perforation or intra-abdominal abscess within the past 6 months; no<br> major surgical procedure within 28 days prior to randomization or anticipation of<br> need for major surgery during the course of study<br><br> - The following are not considered to be major surgical procedures that would be<br> prohibited in the 28 days prior to, or following study randomization: obtaining the<br> required research needle biopsies; placement of a radiopaque clip to localize a<br> tumor or tumors for subsequent surgical resection; placement of a port for central<br> venous access; fine needle aspiration of a prominent or suspicious axillary lymph<br> node; needle biopsy of a clinically or radiographically detected lesion to rule out<br> metastatic disease; or pretreatment sentinel lymph node sampling<br><br> - No baseline neuropathy grade >= 2<br><br> - Zubrod performance status 0-1<br><br> - Pregnant or nursing women are not eligible; all women of reproductive potential must<br> have a negative pregnancy test at baseline and agree to use an effective,<br> non-hormonal method of contraception during the entire period of treatment on the<br> study<br><br> - Patients with congestive heart failure are not eligible, nor are patients with<br> myocardial infarction, unstable angina pectoris, an arterial thrombotic event,<br> stroke or transient ischemia attack (TIA) within the past 12 months, uncontrolled<br> hypertension (systolic blood pressure [SBP] > 160 or diastolic blood pressure [DBP]<br> > 90), uncontrolled or symptomatic arrhythmia, or grade II or greater peripheral<br> vascular disease<br><br> - Patients must have a pretreatment multi gated acquisition (MUGA) scan or<br> echocardiogram with a left ventricular ejection fraction (LVEF) above the<br> institutional lower limit of normal<br><br> - Granulocytes > 1,000/mcl<br><br> - Platelets > 100,000/mcl<br><br> - Total bilirubin =< 1.5 x upper limits of normal<br><br> - Calculated or measured > 30 ml/min<br><br> - Urine protein =< 1+ or urine protein to creatinine (UPC) ratio < 1<br><br> - Patients discovered to have >= 2+ proteinuria at baseline must undergo a<br> 24-hour urine collection that must demonstrate < 1 g of protein/24 hr, or UPC<br> ratio < 1 to allow participation in the study<br><br> - Serum alanine aminotransferase (ALT) =< 2.5 x upper limits of normal<br><br> - Serum beta human chorionic gonadotropin (HCG) negative (for women of child bearing<br> potential)<br><br> - Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x upper limit of<br> normal (ULN)<br><br> - Unless patient is on therapeutic doses of warfarin; if so, the patient must<br> have an INR =< 3 on a stable dose of warfarin, must have not active bleeding or<br> pathologic condition that is associated with a high risk of bleeding

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).;Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).