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Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer


OBJECTIVES:

Primary

- Determine the rate of pathological complete response (i.e., tumor completely gone) in
women with previously untreated, unresected, stage II-IIIB breast cancer treated with
neoadjuvant therapy comprising capecitabine and paclitaxel (albumin-stabilized
nanoparticle formulation) (Abraxane^®).

Secondary

- Evaluate the safety of this regimen in these patients.

- Determine overall clinical response rate in patients treated with this regimen.

OUTLINE: Patients receive up to 4 courses of capecitabine and paclitaxel (nanoparticle
albumin-stabilized formulation) (Abraxane^®) in the absence of disease progression. Patients
then undergo definitive surgical resection of the tumor off study.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed infiltrating carcinoma of the breast or inflammatory breast
cancer

- Stage II-IIIB disease (T1-4, N1-2, M0)

- Previously untreated disease

- Previously unresected disease

- High-risk disease that is not resectable by lumpectomy alone

- Any HER2/neu status (positive, negative, or unknown) allowed

- Hormone receptor status:

- Any estrogen/progesterone status (positive, negative, or unknown) allowed

PATIENT CHARACTERISTICS:

- Female

- Menopausal status not specified

- ECOG performance status 0-2

- Life expectancy > 3 months

- Absolute neutrophil count > 1,500/mm³

- Platelet count > 100,000/mm³

- Hemoglobin > 9.0 g/dL

- Creatinine < 1.5 mg/dL

- Bilirubin < 1.5 times upper limit of normal (ULN)

- ALT and AST < 2.5 times ULN (5 times ULN if due to Gilbert's disease)

- Alkaline phosphatase < 2.5 times ULN (5 times ULN if due to Gilbert's disease)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response rate

Safety Issue:

No

Principal Investigator

Anita Aggarwal, DO, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington Hospital Center

Authority:

Unspecified

Study ID:

CDR0000513169

NCT ID:

NCT00397761

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • inflammatory breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

Name

Location

Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010