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A Phase Ⅳ Randomized Clinical Trial of Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer


Phase 4
18 Years
65 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Phase Ⅳ Randomized Clinical Trial of Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer


Inclusion Criteria:



- Female patients, age ≦ 65 years old

- Histologically or cytologically confirmed primary breast cancer by core biopsy

- Disease stage appropriate for neoadjuvant chemotherapy (T2~T3,N0~2,M0)

- No previous treatment for breast cancer

- No history of other malignancies

- No currently uncontrolled diseased (e.g., ongoing cardiac dysrhythmias, unstable
diabetes) or active infection

- No history of other malignancies

- No currently uncontrolled diseased or active infection

- Not pregnant or breast feeding, and on appropriate birth control if of child-bearing
potential

- Adequate cardiovascular function reserve without a myocardial infarction within the
past six month

- Adequate hematologic function with:

1. Absolute neutrophil count (ANC) ≥ 1500/mm3

2. Platelets ≥ 100,000/ mm3

3. Hemoglobin ≥ 10 g/dL

- Adequate hepatic and renal function with:

1. Serum bilirubin ≤ 1.5×UNL

2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤ 2.5 x ULN.

3. Serum creatinine ≤ 1.7 mg/dl

- Knowledge of the investigational nature of the study and Ability to give informed
consent

- Ability and willingness to comply with study procedures

Exclusion Criteria:

- Known or suspected distant metastases

- Concurrent malignancy or history of other malignancy

- Uncontrolled diseases or active infection

- Hepatic or renal dysfunction as detailed above

- Geographical, social, or psychological problems that would compromise study
compliance

- Known or suspected hypersensitivity to cyclophosphamide, epirubicin and fluorouracil

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response (PCR)

Outcome Description:

pathological evaluation by Miller & Payne Grading System. Pathological complete response (pCR) was defined as no histological evidence of invasive tumor cells in the breast. The presence of DCIS alone was considered as pCR (G5). Residual cancer consisting of scattered tumor cells, not directly measurable, was reported as near pCR (G4)

Outcome Time Frame:

up to four weeks after surgery

Safety Issue:

No

Principal Investigator

Tao Ouyang, Doctor

Investigator Role:

Study Chair

Investigator Affiliation:

Beijing Cancer Hospital Breast Center

Authority:

China: Food and Drug Administration

Study ID:

BCP06

NCT ID:

NCT01199432

Start Date:

October 2010

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Primary Breast Cancer
  • Breast Neoplasms

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