search
Back to results

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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine
paclitaxel albumin-stabilized nanoparticle formulation
neoadjuvant therapy
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Washington Cancer Institute at Washington Hospital Center

Outcomes

Primary Outcome Measures

Pathological complete response rate

Secondary Outcome Measures

Safety
Overall clinical response rate

Full Information

First Posted
November 8, 2006
Last Updated
February 15, 2021
Sponsor
Medstar Health Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00397761
Brief Title
Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer
Official Title
Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medstar Health Research Institute

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Masking
None (Open Label)
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
paclitaxel albumin-stabilized nanoparticle formulation
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
Pathological complete response rate
Secondary Outcome Measure Information:
Title
Safety
Title
Overall clinical response rate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Aggarwal, DO, PhD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Washington Cancer Institute at Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs