Status:
UNKNOWN
Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by Surgery
Lead Sponsor:
National Cancer Centre, Singapore
Conditions:
Breast Cancer
Eligibility:
FEMALE
21+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them f...
Detailed Description
OBJECTIVES: Primary * To evaluate tumor pathological complete response rate after neoadjuvant cyclophosphamide in combination with docetaxel vs doxorubicin hydrochloride in women with operable clini...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Newly diagnosed disease
- Operable disease
- Must have clinical T2 (\> 2cm) or T3 (\> 5 cm) primary tumors with no clinical lymph node involvement (N0)
- No clinical T4 lesion (e.g., peau d'orange, skin ulceration, satellite nodules, or inflammatory breast cancer)
- No evidence of metastatic disease
- Known hormone receptor status
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
- Life expectancy \> 10 years
- Leukocytes ≥ 3,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal or creatinine clearance ≥ 40 mL/min
- Normal cardiac ejection fraction, defined as ≥ 50% by MUGA scan or 2D-ECHO
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or other agents used in this study
- No history of pre-existing peripheral neuropathy
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- No prior malignancies except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No other concurrent investigational or commercial agents or therapies with the intent to treat the patient's malignancy
- No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, surgery for cancer, or experimental medications
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent antitumor therapy
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT00801411
Start Date
October 1 2008
Last Update
June 17 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Singapore General Hospital
Singapore, Singapore, 169608
2
National Cancer Centre - Singapore
Singapore, Singapore, 169610