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

NCT00397761 | Withdrawn Phase 2

• 2 other identifiers: CDR0000513169WHC-MRI-GU-2006-097
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

inflammatory breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

Secondary Outcomes (2)

• Safety

• Overall clinical response rate

Interventions

capecitabine DRUG

paclitaxel albumin-stabilized nanoparticle formulation DRUG

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

Capecitabine; Taxes; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Economics; Health Care Economics and Organizations; Combined Modality Therapy; Therapeutics

Study Officials

• Anita Aggarwal, DO, PhD

  Medstar Health Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2006
• First Posted: November 9, 2006
• Study Start: July 1, 2006
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

US (1)