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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00397761
First received: November 8, 2006
Last updated: February 6, 2009
Last verified: November 2006

November 8, 2006
February 6, 2009
July 2006
Not Provided
Pathological complete response rate [ Designated as safety issue: No ]
Pathological complete response rate
Complete list of historical versions of study NCT00397761 on ClinicalTrials.gov Archive Site
  • Safety [ Designated as safety issue: Yes ]
  • Overall clinical response rate [ Designated as safety issue: No ]
  • Safety
  • Clinical overall response rate
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Phase 3
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: capecitabine
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
  • Procedure: neoadjuvant therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
33
Not Provided
Not Provided

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
Female
18 Years and older
No
United States
 
NCT00397761
CDR0000513169, WHC-MRI-GU-2006-097
Not Provided
Not Provided
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