Clinicaltrials.gov identifier:
NCT04674306
Prevention
Prevention study for people with a BRCA1, BRCA2 or PALB2 inherited mutation who are planning to undergo risk-reducing mastectomy
Study Contact Information:
Contact: George T Budd, MD
1-866-223-8100
[email protected]
Testing a Vaccine for Preventing or Treating Triple-Negative Breast Cancer
About the Study
Researchers are studying the affects of this breast cancer vaccine on the immune system in the following groups:
- Prevention arm:
- people with an in , , or , who have not been diagnosed with cancer, and who are planning to undergo a risk-reducing mastectomy.
- Treatment arms:
- people diagnosed with 2 or 3 who have completed treatment and are considered at high risk for recurrence.
- people diagnosed with 2 or 3 who have completed chemotherapy and radiation and are currently receiving Keytruda (pembrolizumab).
This listing is for people who have never been diagnosed with breast cancer. If you have been diagnosed with triple-negative breast cancer and are interested in joining the treatment portion of the study, see our study listing here.
What the Study Involves
All participants will receive the vaccinations every 2 weeks for a total of 3 doses.
Study Location
Cleveland, Ohio
Cleveland Clinic Case Comprehensive Cancer Center
Contact: George T Budd, MD
1-866-223-8100
[email protected]
Prevention Group:
- People with an inherited mutation in , or .
- Must have no evidence of breast cancer based on both of the following:
- Negative or breast within 180 days.
- Negative breast examination by a physician or advanced practice practitioner within 30 days.
- Must agree to use effective non-hormonal birth control.
- Must agree not to use alternative therapies from the time of informed consent through 30 days following the last vaccine injection. People who are currently using or recently used alternative therapies may be asked to complete a "wash out" period before the first dose of vaccine.
For the full listing visit the clinicaltrials.gov website.
Prevention Group: People with the following are not eligible to participate:
- Received chemotherapy or radiation within the 4 weeks before entering the study.
- Currently receiving steroids or drugs to suppress the immune system.
- Known HIV infection.
- Active or planned pregnancy or nursing.
- Currently taking or planning to take oral contraceptives or using IUD's that contain hormones.
- Receiving any other research medications within the last 4 weeks.
- History of invasive cancer within 5 years of study entry.
- History of allergic reactions to α-lactalbumin or other agents used in this study.
- Uncontrolled illness.
- Have a condition known as hyperprolactinemia.
For the full listing visit the clinicaltrials.gov website.