Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00397761
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : November 9, 2006
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

November 8, 2006
November 9, 2006
February 9, 2009
July 2006
Not Provided
Pathological complete response rate
Same as current
Complete list of historical versions of study NCT00397761 on Archive Site
  • Safety
  • Overall clinical response rate
  • Safety
  • Clinical overall response rate
Not Provided
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Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer
Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II/III trial is studying how well giving capecitabine together with paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing surgery for stage II or stage III breast cancer.



  • 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^®).


  • 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.

Phase 2
Phase 3
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: capecitabine
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
  • Procedure: neoadjuvant therapy
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Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
Not Provided


  • 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


  • 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)


  • See Disease Characteristics
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
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Washington Hospital Center
Not Provided
Study Chair: Anita Aggarwal, DO, PhD Washington Hospital Center
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP