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Phase 4
20 Years
70 Years
Open (Enrolling)
Locally Advanced Breast Cancer

Thank you

Trial Information

Inclusion Criteria:

1. Patients with histologically proven invasive breast cancer - the primary tumor size
is at least 5cm or cytologically proven axillary node metastasis

2. no evidence of systemic metastasis pathologically or radiologically

3. age at the time of diagnosis between 20 and 70 years

4. patients with previously untreated primary breast cancer including chemotherapy

5. general performance status with ECOG 0-2

6. sufficient hematopoietic function (absolute neutrophil count of ≥ 1,500/mm3, platelet
count of ≥ 100,000/mm3, and hemoglobin of ≥ 10 g/dL)

7. sufficient renal function (serum creatinine level of ≤ 1.5 mg/dL)

8. sufficient liver function (total serum bilirubin level ≤ 1.5 times the upper normal
limit; serum AST and ALT levels ≤ 1.5 times the upper normal limit; and serum
alkaline phosphatase level ≤ 1.5 times the upper normal limit)

9. sufficient cardiac function (normal electrocardiography within 1 month or LVEF>50% by
echocardiography or MUGA scan within 3 months)

10. patients who agree to enroll this clinical trial and sign the written informed
consent voluntarily

Exclusion Criteria:

1. patients with evidence of distant metastases

2. patients with other previous malignancy except breast cancer

3. pregnant (positive hCG test 1 week before registration) or lactating patient

4. uncontrolled serious infection

5. patients with psychiatric disease or epilepsy

6. patients with clinically severe cardiac disease within 6 months such as atrial or
ventricular arrhythmia, congestive heart failure, myocardial infarction, or unstable

7. male breast cancer

8. patients with poor general condition who are not able to understand or sign the
written informed consent

Type of Study:


Study Design:

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

Outcome Measure:

Pathologic Complete Response

Outcome Description:

Pathologic complete response is defined as the disappearance of all invasive cancer in the postsurgical breast and lymph node specimens after completion of neoadjuvant chemotherapy. Only residual intraductal carcinoma in the postsurgical breast specimen after neoadjuvant chemotherapy is also considered as the achievement of pathologic complete response.

Outcome Time Frame:

26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens

Safety Issue:



South Korea: Institutional Review Board

Study ID:




Start Date:

May 2011

Completion Date:

May 2016

Related Keywords:

  • Locally Advanced Breast Cancer
  • Breast Neoplasms