Testing a Shorter Course of Chemo- and Immunotherapy (Without Anthracycline Drugs) for People With Early-Stage Triple-Negative Breast Cancer
https://www.facingourrisk.org/research-clinical-trials/study/343/a-study-testing-shorter-safer-chemo-immunotherapy-without-anthracycline-drugs-for-people-with-early-stage-triple-negative-breast-cancer
Clinicaltrials.gov identifier:
NCT05929768 (https://clinicaltrials.gov/show/NCT05929768)
Treatment
Treatment study for early-stage triple-negative breast cancer
Study Contact Information:
Name: Dana Sparks
Phone Number: 210-614-8808
Email: [email protected]
About the Study
This study is testing whether a shorter course of combined chemotherapy and immunotherapy treatment—without a type of chemotherapy drug called anthracycline—works as well as the standard, longer treatment for people with early-stage triple-negative breast cancer at high risk for recurrence.
What the Study Involves
People will be randomly placed into one of two study groups.
Group 1 (Standard Treatment): People will get:
- Four chemotherapy drugs: paclitaxel, carboplatin, cyclophosphamide, doxorubicin (an anthracycline) through an IV (a drip into the vein).
- One immunotherapy drug: pembrolizumab (Keytruda) through IV.
- After chemotherapy and immunotherapy, they will have surgery to remove the cancer.
- Some patients may continue to receive pembrolizumab after surgery.
- Blood samples may be collected during the study.
Treatment lasts up to 8 cycles (24 weeks)
Group 2 (Shorter treatment without anthracycline): People will get:
- Two chemotherapy drugs: docetaxel and carboplatin through IV (a drip into the vein).
- One immunotherapy drug: pembrolizumab (Keytruda) through IV.
- After chemotherapy and immunotherapy, they will have surgery to remove the cancer.
- Some patients may keep getting pembrolizumab after surgery.
- Blood samples may be collected during the study.
Treatment lasts up to 6 cycles (18 weeks)
Follow-Up: Patients will be checked every 6 months for the first 2 years, then once a year up to 5 years after joining the study.
This Study is Open To:
People age 18 or older with breast cancer can join the study if they:
- Have breast cancer that is early stage and has not spread beyond the breast or lymph nodes
- Have triple-negative breast cancer (TNBC) or have very low hormone receptor levels (ER or PR between 1–4%) and their doctor does not plan to give them hormone therapy after treatment.
This Study is Not Open To:
Who cannot join the study if they:
- Have breast cancer that is HR-positive, or HER2-positive
- Have inflammatory breast cancer
- Already had chemotherapy or radiation treatment for breast cancer
- Already had treatment with pembrolizumab or a similar immunotherapy drug
- Are pregnant
Talk with your doctor to learn more about who can join this study.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.