Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Bone Density Conservation Agents

Anti-Infective Agents

Docetaxel

Cyclophosphamide

Tamoxifen

Doxorubicin

Liposomal doxorubicin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Adriamycin will be given at a dose of 50 mg/m2 and docetaxel at a dose of 75 mg/m2 every 14 days for four cycles. Adriamycin will be administered as a short i.v. infusion over 15 minutes, followed immediately by a 1-hour infusion of docetaxel diluted in 250 mL NaCl. Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy.

Adriamycin will be given at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 every 21 days for four cycles. Thereafter, docetaxel at a dose of 100 mg/m2 is given every 21 days for four cycles. Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy

Adriamycin will be given at a dose 50 mg/m2 and docetaxel at a dose of 75 mg/m2 every 14 days for four cycles.Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy.

Adriamycin (Doxorubicin), Docetaxel, Tamoxifen

Adriamycin will be given at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 every 21 days for four cycles. Thereafter, docetaxel at a dose of 100 mg/m2 is given every 21 days for four cycles. Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy.

Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, Cyclophosphamid

The primary objective of this trial is to compare the rate of pathologically complete remissions achieved using a preoperative dose-intensified 8 week therapy consisting of adriamycin and docetaxel with a preoperative sequential 24 week regimen consisting of adriamycin/cyclophosphamide followed by docetaxel, in patients with operable carcinoma of the breast. Secondary aims are to assess disease-free and overall survival, the rate of complete and partial responses by palpation and imaging methods, the rate of breast-conserving operations, and the toxicity of the two chemotherapy regimens.

Women meeting the following criteria will be eligible for the study: those with operable breast cancer (T2-3 N0-2 M0), with the diagnosis histologically confirmed by biopsy, and measurable disease on mammography or sonography or breast MRI (the most appropriate method should be chosen by the investigator). After the patients have given written informed consent, they will be randomly assigned to the study treatments. Patients in group I will receive four cycles of combination chemotherapy consisting of adriamycin 50 mg/m2 (15 min i.v. infusion) and docetaxel 75 mg/m2 (1 h i.v. infusion) repeated every 14 days, followed by surgery 9-10 weeks after the start of therapy. Patients in group II will receive four cycles of adriamycin 60 mg/m2 (15 min i.v.) and cyclophosphamide 600 mg/m2 (1 h i.v.) every three weeks, followed by four cycles of docetaxel 100 mg/m2 (1 h i.v.) every three weeks. Surgery will be performed during week 25 or 26. Patients in both groups will additionally receive oral doses of tamoxifen 20 mg once daily for 5 years, starting on the first day of chemotherapy. Surgery will consist of removal of the remaining tumor (breast-conserving resection or mastectomy) and axillary dissection (Sentinel node biopsy is allowed if the patient is involved in a randomized trial. Radiotherapy is applicated according to standard proceedings of participating center. A second randomization for additional versus no additional postoperative chemotherapy is recommended in ypN+ disease. Patients with disease progression during preoperative therapy, chemotherapy can be stopped and surgery can be performed immediately.

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

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)

German Adjuvant Breast Cancer Group

German Breast Group

Prof. Dr. G. v. Minckwitz

Spots Global Cancer Trial Database for adriamycin (doxorubicin), docetaxel, tamoxifen