Know Cancer

forgot password

Docetaxel by 1 Hour Infusion Followed by 24 Hour Infusion of Cisplatin Plus Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer

Phase 2
65 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Docetaxel by 1 Hour Infusion Followed by 24 Hour Infusion of Cisplatin Plus Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer

This is an open-label phase II trial designed to test the effect and toxicity profile of
combination of docetaxel, cisplatin, and capecitabine in locally advanced breast cancer
patients.Breast cancer is one of the leading causes of cancer death for women in Taiwan.
Despite the advance in multidisciplinary treatment, a significant number of patients
eventually develop metastatic disease, especially those who present with locally advanced
breast cancer (LABC). LABC remains an important and challenging problem in practice. In
LABC, treatment strategies that include neoadjuvant chemotherapy have several potential
advantages: early initiation of systemic therapy, in vivo assessment of response, and
downstaging of primary tumor and regional lymphatic metastases, which makes
breast-conserving surgery an option for many. The potential theoretical shortcomings include
delay in local treatment, introduction of drug resistance, and unreliability of clinical
staging. In practice, the advantages have exceeded the disadvantages. Clinical trial has
demonstrated that docetaxel and capecitabine is highly effective in the treatment of
metastatic breast cancer. On the other hand, our previous study has demonstrated that
combination of taxane and cisplatin is highly effective in the treatment of locally advanced
and metastatic breast cancer. We design a combination chemotherapy using docetaxel with
cisplatin and capecitabine in the treatment of locally advanced breast cancer.

Inclusion Criteria:

- Women with histological proven LABC, without metastasis, and no prior therapy. LABC
is defined as follows:

1. Tumor more than 5 cm in diameter

2. Tumor involvement of chest wall (ribs or intercostals or serratus anterior
muscles) or skin (ipsilateral cutaneous edema, ulceration, or satellite nodules)

3. Clinical evident inflammatory carcinoma

4. 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:


Principal Investigator

Yen-Shen Lu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology , National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

October 2004

Completion Date:

December 2006

Related Keywords:

  • Breast Cancer
  • Breast Cancer , Neoadjuvant Chemotherapy
  • Breast Neoplasms