The primary objective of this trial is to determine the rate of pathologically complete
remissions following a preoperative dose-intensified therapy with doxorubicin and docetaxel
with or without tamoxifen in patients with operable carcinoma of the breast. Secondary aims
are to assess the rate of clinical complete and partial responses, of breast-conserving
operations, and the toxicity of chemotherapy with and without tamoxifen.
Women meeting the following criteria will be eligible for the study: operable breast cancer
(T³3cm N0-2 M0), histologically confirmed diagnosis by core-cut needle or incisional biopsy,
and measurable disease by mammography or sonography or breast MRI (best appropriate method
has to chosen by investigator). After the patients have given written informed consent, they
will be randomised to the study treatments. All patients are scheduled to receive 4 cycles of
combination chemotherapy consisting of doxorubicin 50 mg/m² (15-min i.v. infusion) and
docetaxel 75 mg/m² (1-h i.v. infusion). The patients allocated to group I additionally
receive oral doses of tamoxifen 30 mg once daily, starting on the first day of chemotherapy,
while chemotherapy alone is administered to patients of group II. Cycles should be repeated
every 14 days, followed by surgery 8 weeks after initiation of the trial. Surgery consists of
removal of the remaining tumour (breastconserving resection or mastectomy) and axillary
dissection. Patients with no response or even progression of the primary tumour can be
treated to the discretion of the investigator but should be followed up according to
protocol. If a partial or complete tumour response has been achieved, radiotherapy is given
to the remaining breast in patients undergoing breast conserving therapy, and tamoxifen
treatment is continued for a further 5 years.
Response will be assessed between the 4th cycle and surgery, using the best appropriate
method. Clinical evaluation should be performed after each cycle. It is planned to recruite
200 patients during a period of 1 year.