A Randomized, Multicenter, Open Phase III Study Comparing a Dose-Intensified 8 Week Schedule of Adriamycin and Docetaxel (ADOC) With a Sequential 24 Week Schedule of Adriamycin/Cyclophosphamide Followed by Docetaxel (AC-DOC) Regimen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast (T2-3 N0-2 M0)
- Pre-study screening performed according to section 7.1
- Unilateral primary carcinoma of the breast, confirmed histologically by core or
tru-cut biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is only
allowed if less than 20% of the tumor is excised.
- Two-dimensionally measurable (mammography, ultrasound, or MRI) breast tumor
- Primary tumor >= 2 cm in largest diameter by either palpation, sonography or
mammography, or breast MRI. In patients with multifocal or multicentric breast
cancer, the largest lesion should be measured.
- No evidence of distant metastases
- Life expectancy of at least 10 years, disregarding the diagnosis of cancer.
- Karnofsky index >= 70%.
- Age 18 years or older.
- Adequate hematological, renal, and hepatic function (WBC > 4000, platelets > 100 000,
bilirubin, serum creatinine and transaminases within 1.5 × upper normal range).
- Evidence of normal cardiac function (with or without medication) from the patient
history and from electrocardiography. Normal function is confirmed by
echocardiography or multiple gated acquisition (MUGA) scan.
- Negative pregnancy test and appropriate nonhormonal contraception in fertile women.
Intrauterine pessaries with progestogens are allowed.
- Written informed consent and assumed compliance for therapy and follow up of the
- Consent of patient, pathologist and investigator to supply tumor material of biopsy
and surgery for central pathologic evaluation and examination of predictive factors.
- Locally advanced (stage T4), bilateral, metastatic, or inflammatory breast cancer. If
one of these conditions is suspected, it has to be excluded before enrollment into
- Previous treatment for breast cancer, including surgery, radiation, cytotoxic, or
- Previous malignancy other than breast cancer or noninvasive breast cancer if the
disease-free interval is less than 10 years.
- Previous cytotoxic treatment for any condition.
- Preexisting neurotoxicity greater than grade II.
- Active infection or other significant illness that could influence the tolerability
- Current treatment with sex hormones (treatment has to be discontinued before the
start of systemic therapy).
- Psychiatric illness or drug addiction that would preclude obtaining informed consent.