- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00110695
Therapy With Abraxane and 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) for Patients With Breast Cancer
A Phase 2 Study of Neoadjuvant Chemotherapy With Sequential Weekly Nanoparticle Albumin Bound Paclitaxel (Abraxane) Followed by 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) in Locally Advanced Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- NSABP Operations Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed consent
- Diagnosis made by core biopsy or incisional biopsy
- Histologic confirmation of invasive breast cancer
- Clinical staging as IIB (cT3N0 only), IIIA (cT3N1 or cT0-3N2), or IIIB (cT4N0-2)
- ECOG performance 0 or 1
- At the time of entry: *Absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3; *platelet count must be greater than or equal to 100,000/mm3; *hemoglobin must be greater than or equal to 10 g/dl; *serum creatinine must be less than or equal to ULN for the lab.
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.
- MUGA scan or echocardiogram within 3 months prior to entry if: *age greater than or equal to 60, or *history of hypertension, or *plan to receive trastuzumab. For any patient who has a MUGA scan or echocardiogram performed for any reason, the baseline LVEF must be greater than or equal to LLN for the facility performing the procedure and there must be no regional wall abnormalities
Exclusion Criteria:
- Clinical stage IIB disease that is cT2N1.
- Definitive evidence of metastatic disease (M1 by AJCC criteria)
- Prior history of invasive breast cancer in either breast or ductal carcinoma in situ (DCIS) in the ipsilateral breast treated with radiation therapy (patients with a history of lobular carcinoma in situ [LCIS] are eligible).
- Any treatment for the currently diagnosed breast cancer prior to study entry including radiation therapy, chemotherapy, and/or hormonal therapy.
- Pregnancy or lactation at the time of study entry.
- Prior anthracycline or taxane-containing chemotherapy for any malignancy.
- Nonmalignant systemic disease (cardiovascular, renal, hepatic, diabetes, etc.) that would preclude the patient from receiving study treatment or would prevent required follow-up.
- Grade 2 or greater peripheral polyneuropathy at the time of entry.
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.
- Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to randomization.) Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
- Therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention. Patients are eligible only if these medications are discontinued prior to randomization.
- Use of any investigational agent within the month before enrollment in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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pCR examined in breast tissue taken at surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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pCR examined in breast and lymph node tissue taken at surgery
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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
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physical exam between the two chemotherapy regimens and at completion of the entire treatment regimen
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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
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physical exam and breast imaging at 3-4 weeks after the last chemotherapy treatment
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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
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physical exam at completion of the Abraxane portion of the treatment regimen
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toxicity of the sequential chemotherapy regimen
Time Frame: during treatment and for 3 to 4 weeks after the last chemotherapy cycle
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during treatment and for 3 to 4 weeks after the last chemotherapy cycle
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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
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during treatment and for 3 to 4 weeks after the last chemotherapy cycle
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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
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from the first dose of study therapy to first date of disease progression or for a maximum of 24 months from study entry
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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
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from the first dose of study therapy to date of death or for a maximum of 24 months from study entry
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exploration of molecular and genetic correlates of response
Time Frame: after specimen procurement and continuing after completion of clinical phase of study
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after specimen procurement and continuing after completion of clinical phase of study
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Robidoux A, Buyse M, Buzdar A, et al.: Neoadjuvant chemotherapy with sequential weekly nanoparticle albumin-bound paclitaxel (ABI-007, Abraxane®) followed by 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in locally advanced breast cancer (LABC): a phase II trial of the NSABP Foundation research program (FRP). [Abstract] Annual San Antonio Breast Cancer Symposium 3068, 2006.
- Robidoux A, Buzdar AU, Quinaux E, Jacobs S, Rastogi P, Fourchotte V, Younan RJ, Pajon ER, Shalaby IA, Desai AM, Fehrenbacher L, Geyer CE Jr, Mamounas EP, Wolmark N. A phase II neoadjuvant trial of sequential nanoparticle albumin-bound paclitaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide in locally advanced breast cancer. Clin Breast Cancer. 2010 Feb;10(1):81-6. doi: 10.3816/CBC.2010.n.011.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSABP FB-AX-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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