Docetaxel, Cisplatin and Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer

NCT00155259 | Completed Phase 2

• 1 other identifier: 930607
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The primary endpoint of this phase II trial is the objective response rate of the regimen. The secondary endpoints include treatment-related toxicity, progression free survival and overall survival and breast conserving rate.

Conditions

Breast Cancer

Keywords

Breast Cancer , Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this phase II trial is the objective response rate of the regimen.

  2005~2006

Secondary Outcomes (1)

• The secondary endpoints include treatment-related toxicity, progression free survival and overall survival and breast conserving rate.

  2005~2006

Study Arms (1)

A

EXPERIMENTAL

Drug: Docetaxel , Cisplatin , Capecitabine

Interventions

Docetaxel , Cisplatin , Capecitabine DRUG

A

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with histological proven LABC, without metastasis, and no prior therapy. LABC is defined as follows：
• Tumor more than 5 cm in diameter
• Tumor involvement of chest wall (ribs or intercostals or serratus anterior muscles) or skin (ipsilateral cutaneous edema, ulceration, or satellite nodules)
• Clinical evident inflammatory carcinoma
• Ipsilateral fixed axillary adenopathy
• Measurable disease by physical examination, breast sonography and other image study
• KPS≧ 70%
• Adequate bone marrow reserve, defined as white blood cell (WBC)≧ 3,500/ mm3, absolute neutrophil count (ANC)≧ 1,500/mm3, platelets ≧ 100,000/mm3
• Adequate liver and kidney function: total bilirubin ≦ 2.0 mg/dl, serum alanine transaminases (ALT) and aspartate transaminase (AST) ≦ 3 times upper normal limit, serum creatinine ≦ 1.5 mg/dl
• Patients must be ≦ 65 years old
• Signed informed consent

You may not qualify if:

• Patients who have received prior treatment (including hormonal therapy, chemotherapy, radiotherapy or biological therapy) for LABC. Concomitant use of above therapy will no be allowed.
• Pregnant or lactating woman
• Metastases disease other than regional lymph node metastases (supraclavicular lymph node metastases is not eligible)
• Prior serious cardiac conditions such as angina, myocardial infarction, cardiomyopathy, severe cardiovascular disease or cardiac arrhythmias
• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
• Secondary malignancy in past five years before entry of the study (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin)
• Active infection (at the discretion of the investigator)
• Significant neurological (such as seizures) or psychiatric disorder

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Oncology, National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Cisplatin; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yen-Shen Lu, M.D.

  Department of Oncology , National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: October 1, 2004
• Study Completion: December 1, 2006
• Last Updated: July 25, 2007

Record last verified: 2005-07

Locations

TW (1)