Study Drug Name: Nivolumab (in combination with neoadjuvant* chemotherapy and adjuvant** endocrine therapy)
* Neoadjuvant means given as a first step or primary treatment, typically to shrink a tumor before beginning the main treatment (which is often surgery)
* * Adjuvant means given after primary treatment, like surgery to remove a tumor, or given in addition to another treatment in an attempt to destroy any remaining cancer cells.
Drug Class: Nivolumab, also called Opdivo, may block PD-1 and help the immune system kill cancer cells. It is a type of monoclonal antibody and a type of immune checkpoint inhibitor. A monoclonal antibody is a type of protein made in a lab and designed to bind to only one substance, in this case, cancer cells. They can be used alone or to carry drugs, toxins, or radioactive substances directly to the cancer cells.
Route of administration: Nivolumab is given via an IV.
Duration of Study: Participants may be followed by the study team for up to ten years to confirm whether the combination of medications given during the study impacted disease recurrence or metastases and overall survival.
Target Patient Cancer Type: High-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early-stage breast cancer
Key Inclusion Criteria:
- Estrogen receptor-positive (ER+) breast cancer (BC) and with or without progesterone receptor (PgR) expression
- Tumor Grade 3; Grade 2 is permitted if there is an ER expression level percentage between 1-10% (your doctor can help you determine this, as can the study team if they have access to your medical records)
- Eligible for surgery
Key Exclusion Criteria:
- Breastfeeding, pregnant, or planning to become pregnant during the 12-month screening and treatment period
- Prior treatment with chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiation therapy
- Major cardiovascular disease
- Metastatic disease
- More than one tumor in different parts of the breast or tumors present in both breasts
Diversity Statement: Our vision as a company is only possible if patients can have equal access to healthcare. We know the system doesn’t work for everyone, and the COVID-19 pandemic further highlighted disparities in access to treatment. Together, we can work to provide all patients with fair and just opportunities to achieve optimal health. We know we have a role to play in addressing health equity, and we are taking steps to contribute in areas where we can make a difference. Our commitments include a determined focus on addressing health disparities and increasing clinical trial diversity.
Even as we deepen our efforts to address disparities in healthcare, we understand the responsibility we have to address racial or societal inequity wherever we see it. Following the murder of George Floyd, Bristol Myers Squibb built upon our extensive experience in diversity and inclusion to amplify our efforts and make strategic commitments to accelerate diversity and inclusion. More specifically, our commitments include achieving gender parity at the executive level globally and doubling executive representation of Black/African American and Latino/Hispanic employees in the U.S. by the end of 2022.
Brief Summary: This study is evaluating the efficacy and safety of nivolumab compared to placebo when given with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early-stage breast cancer.
Full Protocol Title: Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer (CheckMate 7FL)
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