Promising advances in treating TNBC: Two studies offer hope
July 2024
Triple negative breast cancer (TNBC) stands out as one of the most challenging and aggressive forms of breast cancer, posing significant hurdles in treatment. Unlike other types of breast cancer, TNBC lacks estrogen and progesterone receptors and epidermal growth factor receptor 2 (HER2), rendering those specific targeted therapies ineffective. As a result, chemotherapy remains the cornerstone treatment. Unfortunately, the outcomes are often disappointing, with chemotherapy showing incomplete anti-tumor response rates and limited overall survival.
Better therapeutic strategies to improve outcomes for people with TNBC are needed. Two studies featured here are designed to move the needle in treatment options and outcomes for people with TNBC. Both studies address patients who have had treatment for early stage TNBC and may require more or less therapy based on their surgical results. The studies are currently enrolling patients at Providence Cancer Institute.
Post-surgery observation versus pembrolizumab
This phase III trial is studying the effect of continuing pembrolizumab treatment for one year compared to simply observing patients with early stage after surgery. The patients participating in this trial will have already achieved a complete response, meaning no signs of cancer were found, after receiving pembrolizumab with their preoperative chemotherapy.
Pembrolizumab is a type of immunotherapy that uses monoclonal antibodies to help the body's immune system attack cancer cells and prevent them from growing and spreading. This trial aims to find out if just observing the patients after surgery is as effective as continuing with pembrolizumab in preventing the cancer from returning.
Multiple study objectives
The primary objective of the study is three-fold:
- To find out if observing patients leads to the same amount of time without cancer coming back as continuing treatment with pembrolizumab
- To compare the quality of life of patients about 27 weeks (about 6 months) after surgery
- To understand the social benefits of reducing additional breast cancer immunotherapy treatment (at 27 weeks after surgery and over a lifetime) through modeling
The secondary objectives are to determine how observation versus pembrolizumab affects recurrence-free survival, adverse events, overall survival, locoregional recurrence and quality of life based on various factors such as stage, prior therapy, age, race and ethnicity. Additionally, the trial will assess the value of reducing breast cancer immunotherapy, including patient costs, financial burden and work productivity at around 27 weeks and over a lifetime.
Learn more about the study
Can a new antibody-drug conjugate offer hope for people with TNBC?
A new study for people with TNBC after surgery aims to determine if the new medication sacituzumab govitecan-hziy, when used with pembrolizumab after surgery, is safe and effective compared to the treatment of physician’s choice (TPC). The treatment physicians usually choose is either pembrolizumab alone or pembrolizumab with capecitabine, a type of oral chemotherapy used to treat various cancers, including breast cancer.
This study is focused on patients with TNBC that had immunotherapy and chemotherapy before surgery and did not achieve a complete response. This means they are still cured with surgery but are at higher risk for a future recurrence of breast cancer.
Sacituzumab govitecan is an antibody-drug conjugate (ADC) designed to deliver powerful anticancer medicine directly into cells with human trophoblast cell-surface antigen 2 (Trop-2), which is expressed in most breast cancers.
Sacituzumab govitecan has three parts:
Once it connects to the cell, sacituzumab govitecan enters and destroys it. This type of targeted treatment is known as a molecular "smart bomb."
The results of a randomized phase III trial published in The New England Journal of Medicine, showed progression-free and overall survival were significantly longer in patients with metastatic TNBC treated with sacituzumab govitecan. The study evaluated sacituzumab govitecan compared with single-agent chemotherapy of the physician’s choice.
Outcomes tracked for up to eight years
The current study is designed to track several outcomes that will help researchers understand how well treatments work and the side effects. The outcome criteria include:
The study will look at the percentage of participants experiencing side effects and lab abnormalities within 38 months. It also will track up to 60 months how long it takes for a patient’s quality of life to decline based on assessment scores.
Providence Cancer Institute is currently enrolling patients in this trial. Alison Conlin, M.D., MPH, medical director, Providence Breast Cancer Medical Program and High-Risk Breast Cancer Clinic, is the principal investigator.
Find out more about this study:
Refer a patient
To learn more or refer a patient to one of these clinical trials, contact our clinical research office:
- Call 503-215-1979
- Submit a referral form
- Send an email
New research studies are added frequently. To see more clinical studies, visit:
- Studies for breast cancer
