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About
The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.
Enrollment
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Volunteers
Inclusion criteria
A patient was eligible for inclusion in this study only if all of the following criteria were met:
Female, age greater than or equal to 18 to less than or equal to 70 years old.
Estrogen receptor (ER) and progesterone receptor (PR) status have been determined.
Operable, histologically confirmed adenocarcinoma of the breast
Must have met 1 of the following criteria:
Patients with one sentinel lymph node metastasis 0.2-2 mm in size were not required to undergo completion axillary dissection unless only 1 sentinel lymph node was examined. This completion axillary dissection was optional if 1 out of 2 or more sentinel lymph nodes was positive for a micrometastasis. Therefore if 1 of 1 sentinel lymph node was positive for micrometastasis(0.2-2 mm), then a completion axillary dissection was required.
Patients with more than one sentinel node micrometastasis or 1 node with a micrometastasis > 2 mm and/or T3 disease must have undergone completion, standard axillary dissection. -Note: the following were not eligible-
T1b,c,N0M0 and ER or PR positive and grade 1 or 2 Tx tumors (regardless of nodal status) T4 disease [i.e., patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes
Negative surgical margins on lumpectomy or mastectomy specimen (no ink on invasive cancer and no ink on ductal carcinoma in situ [DCIS]).
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Normal electrocardiogram (ECG, as assessed by the investigator).
No pre-existing peripheral neuropathy.
It had not been longer than 84 days since the date of definitive surgery (eg, mastectomy or in the case of a breast-sparing procedure, axillary dissection).
Laboratory values were to be as follows:
All staging studies including physical exam, chest x-ray, and bone scan had to show no evidence of metastatic disease, including suspicious lymphadenopathy or skin nodules on physical exam. A chest x-ray and bone scan were mandatory; however, all other staging studies were at the treating physician's discretion. Any other staging test (eg, Computed Tomography [CT] scans, magnetic resonance imaging [MRI] studies, ultrasound of abdomen, Positron Emission Tomography [PET] scans must have been negative for metastatic disease. An abdominal CT scan or PET scan was mandatory for patients with liver function tests elevated above the upper limit of normal (ULN) to rule out metastatic disease. If the patient had a staging PET scan then a bone scan was not necessary, but a chest x-ray was required.
Patient had a negative serum pregnancy test < or equal to 14 days of the first dose of study drug (patients of childbearing potential).
If fertile, patient had agreed to us an acceptable method of birth control to avoid pregnancy [Note: oral contraceptives were not allowed] for the duration of chemotherapy and hormonal therapy and for 6 months thereafter.
If obese, a patient must have been treated with doses calculated using his/her actual body surface area (BSA) (the physician must have been comfortable treating at the full BSA dose regardless of BSA).
Patient had signed a Patient Informed Consent Form.
Exclusion criteria
A patient was not eligible for inclusion in this study if any of the following criteria applied:
Primary purpose
Allocation
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Masking
197 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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