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Phase 2 Study of Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer Patients

Phase 2
18 Years
70 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase 2 Study of Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer Patients

Breast cancer is the leading cause of cancer in women in China. Preoperative chemotherapy
for treatment of locally advanced breast cancer has become a standard therapy. Results from
neoadjuvant trials have shown that pathological complete response (pCR) is an independent
predictor of outcome. Paclitaxel was introduced into clinical practice in the early 1990s
and has demonstrated good activity in the adjuvant and metastatic settings. Platinum
complexes, like cisplatin and carboplatin, are active in a wide range of solid tumors.
Paclitaxel combined with carboplatin has shown great activity in ovarian and nonsmall- cell
lung cancer treatment. In addition, the overall response rate of paclitaxel plus carboplatin
was between 53% and 62% in the first-line treatment of metastatic breast cancer. This study
will evaluate the pCR rate of weekly paclitaxel plus carboplatin as preoperative treatment
for breast cancer patients.

Inclusion Criteria:

- Women aged ≥ 18 years and < 70 years

- Karnofsky performance status (KPS) ≥ 70

- At least one measurable disease according to the RECIST. histologically confirmed
invasive breast cancer (excluding inflammatory breast cancer), large operable (T≥3 cm
and N0-1) or locally advanced breast cancer (T3-4N0-3 or T0-4N2-3)

- Biopsy specimens are available for ER, PgR and Her2 analysis

- Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 100*109/L

- An estimated life expectancy of at least 12 months

- Willing to take biopsy before neoadjuvant chemotherapy and patients must be
accessible for treatment and follow-up

- Women with potential child-bearing must have a negative pregnancy test (urine or
serum) within 7 days of drug administration and agree to use an acceptable method of
birth control to avoid pregnancy for the duration of the study

- Written informed consent according to the GCP

Exclusion Criteria:

- Prior systemic or loco-regional treatment of breast cancer, including chemotherapy

- Metastatic breast cancer

- With a history of malignant tumor except uterine cervix cancer in situ or skin basal
cell carcinoma

- Patients with medical conditions that indicate intolerant to neoadjuvant therapy and
related treatment, including uncontrolled pulmonary disease, diabetes mellitis,
severe infection, active peptic ulcer, coagulation disorder, connective tissue
disease or myelo-suppressive disease

- inadequate liver function (bilirubin > 1.0 times upper normal limit [UNL] and ALT
and/or AST> 1.5 UNL associated with alkaline phosphatase > 2.5 UNL; inadequate renal
function (creatinine > 1.0 times UNL and in case of limit value, Creatinine clearance
< 60 ml/min)

- Contraindication for using dexamethasone

- History of congestive heart failure, uncontrolled or symptomatic angina pectoris,
arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP >
180 mmHg or diastolic BP > 100 mmHg)

- Has peripheral neuropathy ≥ grade 1

- Patient is pregnant or breast feeding

- Known severe hypersensitivity to any drugs in this study

- Treatment with any investigational drugs within 30 days before the beginning of study

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:

pathological complete remission (pCR) rate

Outcome Time Frame:

after 4 cycles of preoperative treatment

Safety Issue:


Principal Investigator

Kunwei Shen, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Jiao Tong University School of Medicine


China: Ethics Committee

Study ID:




Start Date:

December 2007

Completion Date:

December 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Neoadjuvant
  • Chemotherapy
  • Paclitaxel
  • Carboplatin
  • Pathological Complete Remission
  • Breast Neoplasms