Phase 2
N=45
Therapy With Bevacizumab (BEV), Doxorubicin, and Cyclophosphamide Followed by BEV, Docetaxel, and Capecitabine Before Surgery Followed by BEV Alone After Surgery for Women With Locally Advanced Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00365417 ↗Enrolled (actual)
45
Serious AEs
31.1%
Results posted
Aug 2010
Primary outcome: Primary: Pathologic Complete Response (pCR) in the Breast — 4; 38; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Drug); Doxorubicin (Drug); Cyclophosphamide (Drug); Capecitabine (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- NSABP Foundation Inc
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response (pCR) in the Breast |
4; 38; 3 | — |
| SECONDARY pCR in the Breast and Nodes |
4; 38; 3 | — |
| SECONDARY Clinical Response Rate (cRR) of the Sequential Regimen |
77.27 | — |
| SECONDARY Reported Adverse Events |
566 | — |
| SECONDARY Cardiac Events |
— | — |
| SECONDARY Progression-free Survival |
57.69 | — |
| SECONDARY Overall Survival |
74.52 | — |
| SECONDARY Number of Patients With at Least One Surgical Complications (Wound Dehiscence, Infection, Seroma, or Hematoma). |
24 | — |
Summary
Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs kill cancer cells more directly. This study will evaluate:
* How bevacizumab, given with chemotherapy before surgery, and then bevacizumab given alone after surgery, will affect locally advanced breast tumors
* Side effects from adding bevacizumab to chemotherapy
* Whether adding bevacizumab to chemotherapy for breast cancer will affect the heart
* If receiving bevacizumab will have any effect on how patients recover from surgery
* Side effects of the combinations of drugs used in this study
Eligibility Criteria
Inclusion Criteria
- Patients must be female.
- The patient must be greater than/equal to 18 years old
- The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.
- Patients must have clinical Stage IIIA, IIIB, or IIIC disease (American Joint Committee on Cancer [AJCC] staging criteria) with a primary breast tumor that is greater than/equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.
- Patients must have the ability to swallow oral medication.
- The patient's Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
- At the time of study entry, blood counts must meet the following criteria:
- Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.
- Platelet count must be greater than/equal to 100,000/mm^3.
- Hemoglobin must be greater than/equal to 10 g/dL.
- The following criteria for evidence of adequate hepatic function must be met:
- total bilirubin must be less than/equal to upper limit of normal (ULN) for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
- alkaline phosphatase must be less than 2.5 x ULN for the lab; and
- aspartate aminotransferase (AST) must be less than/equal to 1.5 x ULN for the lab.
- Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.
- Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than/equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan or positron emission tomography (PET) scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are confirmed as benign by x-ray, magnetic resonance imaging (MRI), or biopsy.
- Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], MRI, or PET scan) does not demonstrate metastatic disease and adequate hepatic function.
- The following criteria for evidence of adequate renal function must be met:
- Serum creatinine less than/equal to ULN for the lab.
- Calculated creatinine clearance must be greater than 50 mL/min.
- Urine protein/creatinine (UPC) ratio must be less than 1.0.
- Patients must have their left ventricular ejection fraction (LVEF) assessed by multigated acquisition (MUGA) scan or echocardiogram within 3 months prior to study entry. The LVEF must be greater than/equal to the lower limit of normal (LLN) for the cardiac imaging facility performing the MUGA scan or echocardiogram. Note: If the cardiac imaging facility cannot provide a LLN, use 50% as the LLN value.
Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if bevacizumab therapy can be continued following doxorubicin and cyclophosphamide (AC) and postoperatively, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the MUGA scan or echocardiogram must be repeated prior to study entry. The lower of the two LVEF values should be used as the baseline LVEF.
- Patients must have an electrocardiogram (EKG) within 3 months prior to study entry.
Exclusion Criteria
- Tumor determined to be strongly HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification).
- Excisional biopsy for this primary tumor.
- Synchronous bilateral invasive breast cancer.
- Surg
Data sourced from ClinicalTrials.gov (NCT00365417). 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.