Testing a Vaccine for Treating or Preventing 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:

• Treatment arms:
  • people diagnosed with stage 2 or stage 3 triple-negative breast cancer who have completed treatment and are considered at high risk for recurrence.
  • people diagnosed with stage 2 or stage 3 triple-negative breast cancer who have completed chemotherapy and radiation and are currently receiving Keytruda (pembrolizumab).
• Prevention arm:
  • people with an inherited mutation in BRCA1, BRCA2, or PALB2, who have not been diagnosed with cancer, and who are planning to undergo a risk-reducing mastectomy.

This listing is for people who have been diagnosed with triple-negative breast cancer. If you have never been diagnosed with cancer and are interested in joining the prevention 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]

People 18 years or older with the following may be eligible to participate in one of the treatment groups:

Both Groups:

• Invasive stage 2 or stage 3, triple-negative breast cancer.
• At high risk for recurrence due to the presence of cancer cells in the breast or lymph nodes after neoadjuvant chemotherapy (chemotherapy before surgery). 
• No evidence of cancer recurrence based on either bone scan and imaging scans of the chest/abdomen/pelvis or a PET scan.
• Must agree to use effective non-hormonal birth control.
• Must have normal prolactin levels based on a blood test.
• Must agree not to use alternative therapies up to 30 days after the last vaccine injection. People currently using or who recently used alternative therapies may be asked to complete a "wash out" period before their first vaccine dose.

Triple Negative Group:

• At least one month since last active therapy (chemotherapy, radiation therapy, or surgery) and less than three years since the start of treatment for the current cancer.  

Keytruda Group

• At least 1 month since last active therapy with chemotherapy (excluding Xeloda/capecitabine), radiation therapy, or surgery and at least 6 weeks of pembrolizumab therapy planned after the first dose of alpha-lactalbumin vaccine.

For the full listing visit the clinicaltrials.gov website. 

People with the following may not be eligible to participate:

• Any uncontrolled illness including heart disease or heart failure or mental health issues that would limit study participation.
• HIV infection.
• Have received any other research drugs within the last 4 weeks.
• Any recurrence or metastasis.
• History of another cancer within 5 years of beginning the study.
• History of allergic reactions to α-lactalbumin or other agents used in this study.
• A condition called hyperprolactinemia (too much prolactin in the bloodstream).
• Receiving treatment with drugs that cause hyperprolactinemia
• People taking or planning to take oral contraceptives or using IUD's that contain hormones.
• Currently pregnant or nursing or planning to become pregnant or nurse. 
• Have not yet recovered from toxicity or adverse events from previous treatment. 
• Need to be on systemic corticosteroids or immune suppression treatment. 

For the full listing visit the clinicaltrials.gov website.