'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer
OBJECTIVES:
- Compare the 5-year and 10-year disease-free survival and overall survival of women with
completely resected early stage breast cancer treated with adjuvant paclitaxel,
epirubicin, and cyclophosphamide with or without gemcitabine.
- Compare the toxicity, dose-intensity, and tolerability of these regimens in these
patients.
- Compare the serious adverse events in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal
status (negative vs 1-3 vs 4 or more), age (50 and under vs over 50), estrogen receptor
status (negative vs weakly positive vs positive), concurrent radiotherapy (no vs yes), HER2
status (3+ overexpression vs other vs not measured), and country. Patients are randomized to
1 of 2 treatment arms.
- Arm I: Patients receive epirubicin IV, cyclophosphamide IV, and paclitaxel IV over 3
hours on day 1. Patients also receive gemcitabine IV over 30 minutes on days 1 and 8.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity.
- Arm II: Patients receive epirubicin, cyclophosphamide, and paclitaxel as in arm I.
Patients are followed every 3 months for 6 months, every 6 months for 3 years, and then
annually for 6 years.
PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for
this study within 3-4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed invasive breast cancer
- Early stage disease
- Completely resected disease
- No more than 8 weeks since prior resection
- Any nodal status
- Indication for adjuvant chemotherapy
- No metastatic disease
- Hormone receptor status:
- Estrogen receptor negative or weakly positive OR
- Estrogen receptor positive AND progesterone receptor negative or weakly positive
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 3,000/mm3
- Platelet count greater than 100,000/mm3
- Hemoglobin greater than 9 g/dL
Hepatic:
- Bilirubin normal
- AST and ALT no greater than 1.5 times normal
Renal:
- Creatinine no greater than 1.5 times normal
Other:
- Fit to receive study chemotherapy
- No active uncontrolled infection
- No other malignancy within the past 10 years except basal cell carcinoma or carcinoma
in situ of the cervix
- No other concurrent medical or psychiatric problems that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Helen Howard, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Research Campaign Clinical Trials Centre
Authority:
United States: Federal Government
Study ID:
CDR0000069396
NCT ID:
NCT00039546
Start Date:
August 2001
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- Breast Neoplasms
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