Recommendations for enhancing clinical trials education: a review of the literature.

This study aims to apply the evidence-based practice (EBP) process to determine the factors that influence patients' understanding of, participation in, and satisfaction with clinical trials, the informed consent process, and treatment decisions and to make recommendations for improving clinical trials education. Beginning with evidence retrieval, the authors identified key search terms and searched MEDLINE--Ovid, MEDLINE--PubMed, and the Cumulative Index to Nursing and Allied Health Literature to identify articles published between July 2001 and July 2006 that highlighted clinical trials education. The articles were reviewed for clinical trials patient education information, clinician methods of communicating clinical trial information to patients, and patient satisfaction with the clinical trials process, including the informed consent process.

Advances in breast cancer treatment: the emerging role of ixabepilone.

Although taxanes and anthracyclines have dramatically improved the treatment of breast cancer, resistance to these agents upon continued exposure is almost inevitable. The epothilone ixabepilone was US FDA approved in 2007 based on its demonstrated activity in metastatic breast cancer that is resistant to other approved agents, including taxanes and anthracyclines. Over 2000 patients have now received this agent in clinical trials, clarifying that ixabepilone has efficacy in minimally and heavily pretreated patients and can overcome chemotherapy-induced drug resistance, while maintaining a manageable safety profile.

Phase I study of prolonged-infusion gemcitabine combined with cyclophosphamide in patients with metastatic carcinoma of the breast: tolerability of an optimal dose schedule.

Background: A phase I study was initiated to determine the maximum tolerated dose (MTD) of prolonged-infusion gemcitabine combined with cyclophosphamide in patients with metastatic breast carcinoma (MBC).

Methods: Patients with MBC were treated with gemcitabine infusion at 10 mg/m2/min and cyclophosphamide by intravenous piggyback injection, 4 h after initiation of the infusion. We treated 3-6 patients at a particular dose level until the MTD was determined.

Capecitabine-based combination therapy for breast cancer: implications for nurses.

Purpose/objectives: To review available data and implications for nurses of combination regimens containing capecitabine for metastatic breast cancer.

Data Sources: Peer-reviewed publications or abstracts from major oncology conferences and reviews of capecitabine focusing on nursing implications.

Data Synthesis: Capecitabine has proven efficacy in combination with docetaxel and is under evaluation in the neoadjuvant, adjuvant, and metastatic settings in combination with several oral and IV chemotherapeutic and biologic agents.

Clinical course of breast cancer patients with metastases limited to the liver treated with chemotherapy.

Purpose: The purpose of this retrospective analysis was to describe the clinical course of patients with breast cancer with liver metastases alone who were treated on doxorubicin/cyclophosphamide or taxane-containing chemotherapy protocols at the M. D. Anderson Cancer Center.

Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer.

Purpose: The objective of this study was to determine whether the addition of trastuzumab to chemotherapy in the neoadjuvant setting could increase pathologic complete response (pCR) rate in patients with human epidermal growth factor receptor 2 (HER2) -positive disease.

Patients And Methods: Forty-two patients with HER2-positive disease with operable breast cancer were randomly assigned to either four cycles of paclitaxel followed by four cycles of fluorouracil, epirubicin, and cyclophosphamide or to the same chemotherapy with simultaneous weekly trastuzumab for 24 weeks. The primary objective was to demonstrate a 20% improvement in pCR (assumed 21% to 41%) with the addition of trastuzumab to chemotherapy.

The use of alternate, non-cross-resistant adjuvant chemotherapy on the basis of pathologic response to a neoadjuvant doxorubicin-based regimen in women with operable breast cancer: long-term results from a prospective randomized trial.

Purpose: To evaluate the use of an alternate, non-cross-resistant adjuvant chemotherapy regimen in women with a poor pathologic response to a preoperative doxorubicin-based regimen.

Patients And Methods: Patients with locally advanced breast cancer received three cycles of vincristine, doxorubicin, cyclophosphamide, and prednisone (VACP) every 21 days followed by surgery. Patients with less than 1 cm(3) residual tumor at mastectomy received an additional five cycles of VACP.

Phase I study of eniluracil and oral 5-fluorouracil in combination with docetaxel in the treatment of patients with metastatic breast carcinoma.

Purpose: The authors conducted a single-institution Phase I clinical trial to determine the maximum tolerated doses and to define the toxic effects of oral eniluracil and oral 5-fluorouracil (5-FU) combined with docetaxel in patients with metastatic breast carcinoma.

Patients And Methods: Patients with metastatic breast carcinoma were eligible if they had disease progression after anthracycline-based therapy and had never been exposed to taxanes. The starting doses of oral eniluracil and oral 5-FU were 11.

Evaluation of paclitaxel in adjuvant chemotherapy for patients with operable breast cancer: preliminary data of a prospective randomized trial.

Purpose: Paclitaxel has significant antitumor activity in patients with metastaticbreast cancer who have been previously treated with or exposed to anthracycline-containing chemotherapy. In this prospective randomized trial, the role of paclitaxel was evaluated in an adjuvant setting to determine its impact on reducing the risk of recurrence in patients with operable breast cancer.

Experimental Design: Five hundred twenty-four patients were randomized to be treated either with 4 cycles of paclitaxel followed by 4 cycles of combination therapy with 5-fluorouracil, Adriamycin, and cyclophosphamide (Pac/FAC) or with 8 cycles of FAC alone.