204 Participants Needed

Tetrathiomolybdate + Capecitabine + Pembrolizumab for Breast Cancer

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Overseen ByRaven J Lavoie, RN
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Dartmouth-Hitchcock Medical Center
Must be taking: Pembrolizumab
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

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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

I have had surgery and chemotherapy for breast cancer with some remaining cancer.
My scans show no signs of cancer after treatment.
I have never been treated with capecitabine.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Participants receive adjuvant therapy with capecitabine, pembrolizumab, and tetrathiomolybdate (TM) to assess safety.

6 months
Every 3 weeks

Phase 2 Treatment

Randomized treatment with capecitabine and TM, with optional pembrolizumab, to assess efficacy.

3 years
Every 3 weeks for capecitabine, TM continues for 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment.

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Capecitabine
  • Pembrolizumab
  • Tetrathiomolybdate
Trial Overview The study tests adding Tetrathiomolybdate (TM) to standard treatment with Capecitabine and Pembrolizumab in patients who still have cancer after initial treatments. It's done in two parts: first to ensure safety, then comparing TM plus Capecitabine against Capecitabine alone.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: TM and Capecitabine with or without PembrolizumabExperimental Treatment3 Interventions
Group II: Capecitabine with or without PembrolizumabActive Control2 Interventions

Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Xeloda for:
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Approved in United States as Xeloda for:
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Approved in Canada as Xeloda for:
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Approved in Japan as Xeloda for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials
548
Recruited
2,545,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials
59
Recruited
10,600+

Published Research Related to This Trial

Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.
In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]
Pembrolizumab (Keytruda) is approved for treating advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, specifically for patients whose disease has progressed after previous treatments.
This approval is significant for patients who are not candidates for curative surgery or radiation, providing a new therapeutic option for a challenging stage of cancer.
New Approved Use for Keytruda.Aschenbrenner, DS.[2022]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]

Citations

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
New Approved Use for Keytruda. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
A phase II study of pembrolizumab plus carboplatin in BRCA-related metastatic breast cancer (PEMBRACA). [2023]
Pembrolizumab Addition Improves Clinical Response in HER2+ Gastric Cancer. [2022]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Capecitabine (Xeloda) as monotherapy in advanced breast and colorectal cancer: effectiveness and side-effects. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Future options with capecitabine (Xeloda) in (neo)adjuvant treatment of breast cancer. [2019]
A retrospective observational study on the use of capecitabine in patients with severe renal impairment (GFR [2022]
Development of and clinical experience with capecitabine (Xeloda) in the treatment of solid tumours. [2015]
Correction to: Phase II study to evaluate the efficacy of Trastuzumab in combination with Capecitabine and Oxaliplatin in first-line treatment of HER2-positive advanced gastric cancer: HERXO trial. [2020]
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