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

NCT00110695 | Completed Phase 2

• 1 other identifier: NSABP FB-AX-003
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms

Keywords

NSABP; Abraxis; Abraxane; Locally advanced breast cancer; Fluorouracil; Epirubicin; Cyclophosphamide; FEC

Outcome Measures

Primary Outcomes (1)

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

  pCR examined in breast tissue taken at surgery

Secondary Outcomes (9)

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

  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

  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

  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

  physical exam at completion of the Abraxane portion of the treatment regimen

• toxicity of the sequential chemotherapy regimen

  during treatment and for 3 to 4 weeks after the last chemotherapy cycle

Study Arms (1)

A

EXPERIMENTAL

Drug: Nanoparticle albumin bound paclitaxel followed by FEC

Interventions

Nanoparticle albumin bound paclitaxel followed by FEC DRUG

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

A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• Celgene Corporation: collaborator

Study Sites (1)

NSABP Operations Center

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 20133263 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Norman Wolmark, MD

  NSABP Foundation Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 12, 2005
• First Posted: May 13, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: July 1, 2008
• Last Updated: March 26, 2010

Record last verified: 2010-03

Locations

US (1)