NCT00001384 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hryniuk W, Bush H
The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol. 1984 Nov;2(11):1281-8. Review.
Jones RB, Holland JF, Bhardwaj S, Norton L, Wilfinger C, Strashun A
A phase I-II study of intensive-dose adriamycin for advanced breast cancer. J Clin Oncol. 1987 Feb;5(2):172-7.
Wheeler RH, Ensminger WD, Thrall JH, Anderson JL
High-dose doxorubicin: an exploration of the dose-response curve in human neoplasia. Cancer Treat Rep. 1982 Mar;66(3):493-8.

A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients

Details for clinical trial NCT00001384

Clinical trial NCT00001384 - References