National Breast Cancer Coalition

NBCC's Clinical Trials Partnerships

Clinical Trials for Women and Men with Breast Cancer

NBCC and its advocates want to make certain that well-designed clinical trials of interventions that may save lives and change the way women and men are treated, move forward quickly and with input from advocates. As a result, we have been involved in many ways on numerous clinical trials. NBCC’s Project LEAD trained advocates participate in early development of the trial protocol, as members of the Steering Committee and Data Safety Monitoring Board, as reviewers of educational materials and consent forms, and in conducting outreach activities to educate the public about specific trials.

Current trials we are involved with are listed below.

NATALEE clinical trial for the CDK4/6 inhibitor Ribociclib [LEE-011]

NBCC is currently partnering with Translational Research in Oncology (TRIO) and Novartis Pharmaceuticals on a clinical trial in the adjuvant setting for women and men with hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer.

NATALEE is a phase 3, multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib (a CDK 4/6 inhibitor) with endocrine therapy as an adjuvant treatment in patients with HR+/HER2- breast cancer. The intervention under study offers the potential of reducing the risk of recurrence in patients with early, but high-risk breast cancer. Trial accrual has begun.

Purpose of the study: To evaluate the efficacy and safety of Ribociclib [LEE-011] in the adjuvant setting.

Eligibility:

  • Patient is ≥18 years-old

  • Patient is female with known menopausal status, or male.

  • Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.

  • Patient has breast cancer that is positive for ER and/or PgR

  • Patient has HER2-negative breast cancer

  • Patient has available archival tumor tissue from the surgical specimen

  • Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and who belongs to one of the following categories (anatomic stage group II or III)


Other eligibility criteria and trial details can be found at: 
https://clinicaltrials.gov/ct2/show/NCT03701334  

For Interested Patients: To learn more about this study and whether it is right for you, you or your doctor may contact the study research staff using the contact information provided at: https://clinicaltrials.gov/ct2/show/NCT03701334#contacts