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Therapy With Abraxane and 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) for Patients With Breast Cancer

Information source: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms

Intervention: Nanoparticle albumin bound paclitaxel followed by FEC (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: National Surgical Adjuvant Breast and Bowel Project (NSABP)

Official(s) and/or principal investigator(s):
Norman Wolmark, MD, Principal Investigator, Affiliation: NSABP Foundation, Inc.

Summary

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.

Clinical Details

Official title: 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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: pathologic complete response rate in the breast for patients with locally advanced breast cancer (LABC) who receive Abraxane

Secondary outcome:

pathologic complete response rate in the breast and axillary nodes (pCR breast and nodes) in all patients

complete clinical response rate (cCR) of the sequential regimen in patients who present with palpable measurable disease

complete clinical and imaging response rate (ciCR) of the sequential regimen in all patients

complete clinical response rate (cCR)of Abraxane in patients who present with palpable measurable disease

toxicity of the sequential chemotherapy regimen

toxicity of the sequential chemotherapy regimen when administered concurrently with trastuzumab

2-year progression-free survival

2-year overall survival (OS)

exploration of molecular and genetic correlates of response

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Locations and Contacts

NSABP Operations Center, Pittsburgh, Pennsylvania 15212, United States
Additional Information

Related 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.

Starting date: April 2005
Ending date: May 2008
Last updated: December 14, 2007

Page last updated: June 20, 2008

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