Breast Cancer Steering Committee
The NCI Breast Cancer Steering Committee (BCSC) was established in September 2008. At monthly meetings, it addresses the design, prioritization, and evaluation of concepts for phase 2 and phase 3 treatment trials in adult breast cancer. View the BCSC member roster.
- BCSC Strategic Priorities were formulated with the goal that the majority of submitted concepts would align with these established priorities. They address areas of unmet clinical need, important unanswered clinical questions, and potential new approaches to disease treatment.
Breast Oncology Local Disease (BOLD) Task Force
- BOLD was established to provide early input into concepts for studies of localized breast cancer treated with surgery or radiation therapy prior to review by the BCSC. One of BOLD’s projects was to develop case report forms specifically for localized breast cancer trials. If you need help accessing the case report forms, view our step-by-step instructions.
Breast Immuno-Oncology (BIO) Task Force
- The BIO Task Force was established to provide early input into concepts for studies that define the role of immunotherapy in the treatment of breast cancer patients, prior to review by the BCSC.
Clinical Trials Planning Meetings (CTPMs)
CTPMs are held periodically and focus on specific clinical trial related topics. The following are important BCSC CTPMs:
- Identification and Treatment of Patients at Risk for Late Recurrence of ER+ Breast Cancer
Estrogen Receptor-positive (ER+) breast cancer patients, especially those with nodal involvement, face a significant risk of late recurrence and associated poor clinical outcomes. More than half of recurrences occur beyond five years after diagnosis. Although treatment with chemotherapy and adjuvant endocrine therapy may have some benefit, they provide a minimal reduction in absolute risk and cause side effects that impact patient quality of life. This 1.5-day CTPM held in May 2019 laid the framework for the development of a clinical trial to test an intervention for patients at high risk of late recurrence of ER+ breast cancer. Read the executive summary.
- Omitting Surgery in Patients with Complete Clinical/Radiologic Response to Neoadjuvant Chemotherapy: A Paradigm Shift
Certain subtypes of breast cancer patients (triple-negative and HER2 positive) have high rates of pathologic complete response to neoadjuvant systemic therapy (43-67%). Patients treated with neoadjuvant chemotherapy who achieve a pathologic complete response have a very low rate of local recurrence and excellent overall survival, leading to an interest in the concept of eliminating surgery in these patients. Prior studies have suggested that it may be feasible to omit surgery but were not performed using current systemic therapy regimens or imaging techniques. Current and prior data set the stage for a trial that will definitively determine whether it is safe to omit surgery in patients that are predicted to have a high probability of pCR. The goal of this 1.5-day CTPM in October 2017 was to develop design recommendations for a clinical trial to determine if surgery can be omitted for a subset of breast cancer patients who have a complete clinical/radiologic response to neoadjuvant chemotherapy. Read the executive summary.
- Life Style Intervention for Improving Disease-Free Survival in Early Stage Invasive Breast Cancer
Several small studies suggested that a lifestyle intervention including exercise and weight loss might improve disease-free survival in women with invasive breast cancer. To address this topic in detail, in February 2014, a 1.5-day meeting resulted in the development of a trial, the Breast Cancer WEight Loss Study (BWEL Study), which is currently enrolling patients. Read the executive summary. Learn more about the study.
- Next Generation Trials for Estrogen Receptor (ER) Positive Breast Cancer
Although estrogen receptor (ER)-positive breast cancer has a relatively good 5-year prognosis, patients continue to relapse over time, making ER-positive breast cancer the majority of breast cancer deaths and thus in need of new clinical trials. The goals of the meeting were to address strategies to improve outcomes from clinical trials of any class of treatment in any stage of ER-positive breast cancer with a scientific focus on overcoming mechanisms of resistance to hormonal therapy. The May 2012 CTPM developed common definitions/clinical classification for endocrine resistance considering early stage and metastatic disease. It also concluded that standardized guidance on biopsies (compulsory and non-compulsory) and specimen storage is needed. Read the executive summary.
- Next Generation Trials for HER2 Positive Breast Cancer
HER2-positive breast cancers, about 15 - 20% of breast cancers, are generally more aggressive, respond less to hormone therapy, and are more prone to recurrence. This May 2011 CTPM addressed which agent(s) should be tested in the next generation of phase II and III clinical trials and the need to develop a more complete understanding of the mechanisms of resistance to HER2-directed therapies. Read the executive summary.
For more information, contact Lawrence Baizer, Ph.D., at email@example.com.