Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Breast Neoplasms

Thank you

Trial Information

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

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

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.

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

- Grade 2 or greater peripheral polyneuropathy at the time of entry.

- Cardiac disease that would preclude the use of anthracyclines or trastuzumab. This

*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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

pCR examined in breast tissue taken at surgery

Safety Issue:


Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

July 2008

Related Keywords:

  • Breast Neoplasms
  • Abraxis
  • Abraxane
  • Locally advanced breast cancer
  • Fluorouracil
  • Epirubicin
  • Cyclophosphamide
  • FEC
  • Breast Neoplasms
  • Neoplasms



NSABP Operations Center Pittsburgh, Pennsylvania  15212