NSABP Breast Cancer Clinical Trials: Recent Results and Future Directions

Abstract

Over the past 40 years, the National Surgical Adjuvant Breast and Bowel Project (NSABP) has conducted several large, randomized clinical trials evaluating various aspects of surgical and adjuvant therapy in patients with operable breast cancer. Results from these trials have contributed significantly in reducing the extent of surgical procedures and in improving the outcome of patients with early-stage breast cancer. Furthermore, they have helped to establish standards of care for the surgical management of invasive and non-invasive disease and for the use of adjuvant hormonal therapy and adjuvant chemotherapy for patients with negative as well as for those with positive axillary nodes. More recent trials are evaluating several new classes of promising drugs such as the aromatase inhibitors in postmenopausal women with invasive or intraductal breast cancer, the taxanes for patients with positive nodes and in the neoadjuvant setting and other targeted molecular therapies such as trastuzumab and bisphosphonates. Results from these ongoing and recently completed trials could improve outcomes and quality of life for patients with early-stage breast cancer.

Study to Compare TAC versus FAC Regimen as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancers

“…The difference of results between our study and the trial reported by Batra et al could be due to G-CSF administration in our study (22) . The limited data of the present study and data from large published trials support a combined doxorubicin and docetaxel regimen for neoadjuvant treatment (1,20,23) .…”

Bisphosphonates in Oncology: Rising Stars or Fallen Heroes

“…A recent meta-analysis of these trials concluded that there was no evidence to suggest that adjuvant clodronate therapy improves 5-year overall (HR, 0.75; 95% CI, 0.31-1.82), bone metastasis-free (HR, 0.68; 95% CI, 0.38 -1.23), or nonskeletal metastasis-free (HR, 0.89; 95% CI, 0.40 -1.98) survival in breast cancer patients [68]. Hopefully, a more definitive judgment on clodronate can be rendered when the eagerly awaited National Surgical Adjuvant Breast and Bowel Project B34 trial, which has accrued 3,000 patients, investigating adjuvant oral clodronate in patients with resected stage I-II breast cancer, has accumulated enough events to be reported, probably later this year [69].…”

Neoadjuvant Therapy in Breast Cancer

“…pCR, pathological complete response; vinb, vinblastine; thi, thiotepa; met, methotrexate; FU, 5-flourouracil; adr, adriamycin; cyc, cyclophosphamide; epi, epirubicin; cis, ciplatin; doc, docetaxel; dox, doxorubicin; vinc, vincristine; vino, vinorelbine; tam, tamoxifen; pac, paclitaxel. 6,7 . 1493 patients with operable breast cancer were stratified by age, clinical tumor size, and clinical nodal status to preoperative versus postoperative administration of Adriamycin/cyclophosphamide (AC) q 21 days x four cycles.…”

“…Breast conservation therapy (BCT) rates were 67% versus 60%. Another landmark trial, NSABP B-27, enrolled 2411 patients in a randomized prospective trial to compare the efficacy of docetaxel in the preoperative versus postoperative setting after neoadjuvant AC x four cycles 7 . The patients were randomized into three groups ( Figure 1).…”