Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-Doc) Versus Dose-Dense Doxorubicin and Docetaxel (ADoc) in Breast Cancer

Inclusion Criteria

• •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 patients.
• •Consent of patient, pathologist and investigator to supply tumor material of biopsy and surgery for central pathologic evaluation and examination of predictive factors.