Tetrathiomolybdate + Capecitabine + Pembrolizumab for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
There are two parts to this study. It is a phase 1b followed by a randomized phase 2 study to assess whether adding 3 years of adjuvant tetrathiomolybdate (TM) to standard 6 months treatment of adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer.In the phase 1b part of the study, TM is added to adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer (RCB 2, 3, risk for relapse \>60% at 5 years) after completion of neoadjuvant chemo-immunotherapy and surgery to establish the safety of the combination. This will be followed by a randomized phase 2 clinical trial of adjuvant TM and capecitabine vs capecitabine alone.If pembrolizumab was administered in the neoadjuvant setting, it may be continued in the adjuvant setting per investigator discretion.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking capecitabine or warfarin. You must also be on stable medical therapy for at least 2 weeks if you are being treated for chemotherapy-induced peripheral neuropathy.
What safety information is available for Pembrolizumab (Keytruda) in humans?
Pembrolizumab (Keytruda) has been associated with some side effects, including pneumonitis (lung inflammation) in 1%-5% of patients and rare cases of type 1 diabetes. Common side effects include fatigue, cough, nausea, and rash, while more serious immune-related reactions can affect organs like the lungs, liver, and thyroid.12345
What makes the drug combination of Tetrathiomolybdate, Capecitabine, and Pembrolizumab unique for breast cancer treatment?
This drug combination is unique because it combines Capecitabine, an oral drug that targets cancer cells directly at the tumor site, with Pembrolizumab, an immunotherapy that helps the immune system attack cancer cells. This approach may offer a novel way to treat breast cancer by combining targeted chemotherapy with immune system activation.678910
What data supports the effectiveness of the drug pembrolizumab in treating breast cancer?
Pembrolizumab has shown effectiveness in treating various cancers, including breast cancer, when combined with other treatments. It has been used successfully in other types of cancer, like lung cancer, where it improved survival rates, suggesting potential benefits in breast cancer as well.111121314
Who Is on the Research Team?
Linda Vahdat, MD
Principal Investigator
Study Principal Investigator
Are You a Good Fit for This Trial?
This trial is for adults with triple-negative breast cancer who have a high risk of the cancer returning. They must have finished at least 6 cycles of specific chemotherapy, had surgery, and possibly radiation therapy. They can't join if they've been treated with capecitabine before or if their performance status is low (KPS less than 90).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1b Treatment
Participants receive adjuvant therapy with capecitabine, pembrolizumab, and tetrathiomolybdate (TM) to assess safety.
Phase 2 Treatment
Randomized treatment with capecitabine and TM, with optional pembrolizumab, to assess efficacy.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Capecitabine
- Pembrolizumab
- Tetrathiomolybdate
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Congressionally Directed Medical Research Programs
Collaborator