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Contact Information

General Phone Number
888-844-8447
216-844-8447
Mailing Address
11100 Euclid Avenue
Cleveland, OH 44106
Clinical Trials

Trial Name:

NSABP B-38
Intro: A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women with Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC -P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC -PG).
Condition:
Description: This is a study to determine whether a regimen of dose-dense doxorubicin and cyclophosphamide followed by dose-dense paclitaxel and gemcitabine will be superior to a regimen of docetaxel, doxorubicin, and cyclophosphamide as well as to a regimen of dose-dense doxorubicin and cyclophosphamide followed by dose-dense paclitaxel alone in improving disease-free survival in women with node positive breast cancer. Patients will be randomly assigned to one of four regimens: (1) doxorubicin/cyclophosphamide (AC2) given every two weeks with pegfilgrastim support followed by paclitaxel also given every two weeks with pegfilgrastim support (T2); (2) an alternative dose-schedule of doxorubicin/cyclophosphamide with cyclophosphamide given orally on a daily basis and doxorubicin given weekly with filgrastim support followed by T2; (3) AC2 followed by paclitaxel administered weekly (T1); or (4) continuous AC+G regimen followed by T1.
Criteria:
  1. The interval between last surgery for breast cancer staging or treatment and randomized must be not more than 84 days
  2. Patient’s tumor must be invasive carcinoma of the breast on histological examination
  3. Patients must have had either a lumpectomy or a total mastectomy
  4. Patients must complete one of the following procedures for evaluation of pathologic nodal status: sentinel lymphadenectomy followed by removal of additional non-sentinel lymph node; sentinel lymphadenectomy according to criteria; or an axial lymphadenectomy
  5. Patients must have no clinical or radiologic evidence of metastatic disease
  6. Patients must be female with a life expectancy of at last 10 years and a Zubrod performance status of 0 or 1.
Contact: For Cancer Information, Current Clinical Trials, and Referral to a Physician please call (216) 844-5432 or (800) 641-2422

Participant Confidentiality:

All information regarding participation in Clinical Trials is treated with the utmost confidentiality. University Hospitals Case Medical Center and the Division of Clinical Research recognize and respect the confidentiality of this information. Access to information related to clinical trials and their participants is restricted to authorized clinical trials personnel only.

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