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Phase 2 N=105 Treatment

Therapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer

Breast Cancer

Enrolled (actual)
105
Serious AEs
20.0%
Results posted
Sep 2012
Primary outcome: Primary: Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A) — 34 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Epirubicin (Drug); Cyclophosphamide (Drug); Docetaxel (Drug); Trastuzumab (Drug); Bevacizumab (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
NSABP Foundation Inc
Primary completion
Dec 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)
34
PRIMARY
Number of Participants With Cardiac Events
4; 0
SECONDARY
Number of Participants With no Histologic Evidence of Invasive Tumor Cells in the Surgical Breast Specimen.
36; 0
SECONDARY
Clinical Complete Response (cCR)
61.43
SECONDARY
Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)
55; 22
SECONDARY
Recurrence-free Survival
75.97; 89.66
SECONDARY
Overall Survival
12; 0
SECONDARY
Percentage of Participants With Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)
37

Summary

The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab to treat HER2-positive breast cancer will affect heart function. This study will evaluate: * How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab after surgery, will affect breast tumors * Side effects from adding bevacizumab to chemotherapy and trastuzumab * Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect the heart * If receiving bevacizumab will have any effect on how patients recover from surgery

Eligibility Criteria

Inclusion Criteria

Conditions for eligibility for patients with LABC (Cohort A):

  • 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 with a mass in the breast or axilla that is greater than or equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.

Conditions for eligibility for patients with resected Stage III breast cancer (Cohort B)

  • Patients must have undergone either a total mastectomy or a lumpectomy.
  • Patients must have completed one of the following procedures for evaluation of pathologic nodal status.
  • Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes, or
  • Axillary lymphadenectomy without SN isolation procedure.
  • The interval between the last surgery (for breast cancer treatment or staging) and study entry must be no more than 84 days.
  • By pathologic evaluation, ipsilateral nodes must be pN2 or pN3.
  • For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)
  • For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.

Conditions for patient eligibility (ALL patients)

  • The patient must have consented to participate and must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
  • Patients must be female.
  • The patient must be greater than or equal to 18 years old.
  • The patient's ECOG performance status must be 0 or 1.
  • The tumor must be invasive adenocarcinoma of the breast on histologic examination.
  • The breast cancer must be determined to be HER2-positive prior to study entry. Assays performed using FISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.
  • 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/mm3.
  • 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 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
  • 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 AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, or PET scan) does not demonstrate metastatic disease, and has adequate hepatic function.
  • 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 PET scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00464646). 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.

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