Phase 2
Completed N=454
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
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
Source: ClinicalTrials.gov NCT00861705 ↗
Enrolled (actual)
454
Serious AEs
23.3%
Results posted
Mar 2015
Primary outcomePrimary: Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). — 60; 46 percentage of participants with pCR — p=0.0018
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). |
59; 48 | 0.0089 sig |
| SECONDARY Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0). |
52; 44 | 0.057 |
| SECONDARY Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6) |
42; 49; 51; 70; 42; 55 | — |
| SECONDARY Radiographic Response Assessed by Tumor Measurement |
11; 12; 19; 13; 16; 11 | — |
| SECONDARY Clinical Response Assessed by Tumor Measurement |
28; 35; 45; 40; 37; 38 | — |
| SECONDARY Overall Survival |
22; 26; 30; 24 | — |
| SECONDARY Recurrence-free Survival |
32; 34; 37; 27; 76; 76 | — |
| SECONDARY Count of Participants With a First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause |
23; 26; 28; 22; 85; 84 | — |
| SECONDARY Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence. |
0; 0; 1; 0; 1; 0 | — |
Eligibility Criteria
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 = = 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 = 30 ml/min
- Urine protein = = 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
Data sourced from ClinicalTrials.gov (NCT00861705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.