A Phase 2 interventional study of Nanoparticle albumin bound paclitaxel followed by FEC in Breast Neoplasms, sponsored by NSABP Foundation Inc. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-26.
Sponsored by NSABP Foundation Inc · Phase 2, Interventional, and Treatment
The purpose of this study is to learn how breast cancer tumors respond to a drug called Abraxane followed by a combination of 3 chemotherapy drugs commonly used for breast cancer.
This is a Phase 2, non-randomized study of neoadjuvant treatment with nanoparticle albumin bound paclitaxel (Abraxane) every week for 12 weeks followed by 5-FU, epirubicin, and cyclophosphamide (FEC) every 3 weeks for 4 cycles in women with locally advanced breast cancer. Patients with HER-2 overexpressing breast cancer may receive trastuzumab concurrently with the chemotherapy at the discretion of the investigator. The primary aim of this study is to determine the pathologic complete response rate (pCR) of this sequential regimen.
Patients who achieve clinical complete response (cCR), clinical partial response (cPR), or have resectable stable disease (SD) will undergo surgery. Surgery will consist of modified radical mastectomy or excision of the primary tumor site with clear surgical margins accompanied by axillary staging. Tumor samples taken prior to initiation of treatment will be analyzed for molecular and genetic changes which will be correlated with tumor response.
Patients must have a histologically confirmed diagnosis of breast cancer without documented evidence of distant metastatic disease. Patients with clinical Stage IIB (T3N0 only), IIIA, or IIIB breast cancer will be potential candidates for this trial.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 66 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →NSABP Foundation Inc is the lead sponsor of 64 studies on the registry; 1 is open to participants now.
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The following criteria for evidence of adequate hepatic function must be met: *Total bilirubin must be less than or equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and *alkaline phosphatase must be \< 2.5 x ULN for the lab; and
*AST must be less than or equal to 1.5 x ULN for the lab.
Exclusion Criteria:
Cardiac disease that would preclude the use of anthracyclines or trastuzumab. This includes:
*myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; *angina pectoris that requires the use of anti-anginal medication; *any history of documented congestive heart failure; *serious cardiac arrhythmia requiring medication; *severe conduction abnormality; *valvular disease with documented cardiac function compromise; or *uncontrolled hypertension defined as blood pressure > 160/100 mm/Hg.
Drug: Nanoparticle albumin bound paclitaxel followed by FEC
Nanoparticle albumin bound paclitaxel 100 mg/m2 IV for 30 minutes once weekly for 12 weeks followed by FEC (5-FU 500mg/m2 IV push; epirubicin 100 mg/m2 IV over 15 min. \[or if given with trastuzumab 75 mg/m2 IV over 15 min.\]; cyclophosphamide 500 mg/m2 IV over 30 min.) on Day 1 every 21 days
pathologic complete response rate in the breast for patients with locally advanced breast cancer (LABC) who receive Abraxane
Time frame: pCR examined in breast tissue taken at surgery
pathologic complete response rate in the breast and axillary nodes (pCR breast and nodes) in all patients
Time frame: pCR examined in breast and lymph node tissue taken at surgery
complete clinical response rate (cCR) of the sequential regimen in patients who present with palpable measurable disease
Time frame: physical exam between the two chemotherapy regimens and at completion of the entire treatment regimen
complete clinical and imaging response rate (ciCR) of the sequential regimen in all patients
Time frame: physical exam and breast imaging at 3-4 weeks after the last chemotherapy treatment
complete clinical response rate (cCR)of Abraxane in patients who present with palpable measurable disease
Time frame: physical exam at completion of the Abraxane portion of the treatment regimen
toxicity of the sequential chemotherapy regimen
Time frame: during treatment and for 3 to 4 weeks after the last chemotherapy cycle
toxicity of the sequential chemotherapy regimen when administered concurrently with trastuzumab
Time frame: during treatment and for 3 to 4 weeks after the last chemotherapy cycle
2-year progression-free survival
Time frame: from the first dose of study therapy to first date of disease progression or for a maximum of 24 months from study entry
2-year overall survival (OS)
Time frame: from the first dose of study therapy to date of death or for a maximum of 24 months from study entry
exploration of molecular and genetic correlates of response
Time frame: after specimen procurement and continuing after completion of clinical phase of study
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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NSABP Foundation Inc