Low-dose Cytotoxics as "Anti-angiogenesis Treatment" Following Adjuvant Induction Chemotherapy for Patients With ER-negative and PgR-negative Breast Cancer
OBJECTIVES:
- Determine the efficacy of adjuvant induction chemotherapy with or without
cyclophosphamide and methotrexate as maintenance chemotherapy in patients with stage I,
II, or III breast cancer.
- Compare the disease-free survival, overall survival, and systemic disease-free survival
of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center, menopausal status (pre vs post), and approved induction
chemotherapy (doxorubicin and cyclophosphamide vs other agents). Patients are randomized to
one of two treatment arms.
- Arm I: Patients receive one of the following approved adjuvant induction chemotherapy
regimens:
- AC comprising doxorubicin and cyclophosphamide IV on day 1 every 21 days for 4
courses followed by paclitaxel IV or docetaxel IV on day 1 every 21 days for 4
courses
- EC comprising epirubicin and cyclophosphamide IV on day 1 every 21 days for 4
courses followed by paclitaxel IV or docetaxel IV on day 1 every 21 days for 4
courses
- FAC comprising cyclophosphamide, doxorubicin, and fluorouracil IV on days 1 every
21 days for 4 courses
- Doxorubicin every 21 days for 4 courses followed by CMF comprising
cyclophosphamide IV, methotrexate IV, and fluorouracil IV on days 1 and 8 every 28
days for 4 courses
- AC OR EC and paclitaxel IV with filgrastim (G-CSF) every 14 days for 4 courses
- FEC comprising cyclophosphamide IV, epirubicin IV and fluorouracil IV on day 1
every 21 days for 3 courses followed by docetaxel IV on day 1 every 21 days for 3
courses
- TAC comprising docetaxel, doxorubicin, and cyclophosphamide IV on day 1 every 21
days for 6 courses
- AT comprising doxorubicin IV and docetaxel IV every 21 days for 3 courses followed
by CMF for 3 courses
- Arm II: Patients receive adjuvant induction chemotherapy as in arm I. Beginning within
56 days after the first day of the last course of induction chemotherapy, patients
receive CM (maintenance chemotherapy) comprising oral cyclophosphamide once daily and
oral methotrexate two times a day twice weekly for 1 year.
Patients with breast-conserving surgery receive radiotherapy following completion of
induction chemotherapy.
Patients with HER2-positive primary breast cancer may also receive trastuzumab (Herceptin)
during or following induction, and/or during and following CM.
Quality of life is assessed at baseline, at the beginning of each course of induction
chemotherapy, and at months 9, 12, 18, and 24.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: Approximately 900 patients will be accrued for this study within 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival
Estimated 10 years after last patient in
No
Marco Colleoni, MD
Study Chair
European Institute of Oncology
Switzerland: Swissmedic
CDR0000068827
NCT00022516
November 2000
Name | Location |
---|