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New treatment option for Triple Negative Breast Cancer
Official title A Study of Tetrathiomolybdate (TM) Plus Capecitabine
ClinicalTrials.gov ID: NCT06134375
What this study is testing
What is Tetrathiomolybdate?
Tetrathiomolybdate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for triple negative breast cancer.
Also referred to as TM.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients must have histologically confirmed breast malignancy that is Triple negative tumors as defined as ER and PR \<1% and HER2 negative as per...
- The patient must have completed standard neoadjuvant chemotherapy which constitutes at least 6 cycles of chemotherapy.
- Phase Ib: Patients must have residual invasive carcinoma, at minimum in one of the following capacities: (1) node positive disease after treatment...
- At least two weeks must have elapsed from last chemotherapy or radiation therapy. At least 4 weeks must have elapsed from most recent surgery.
- No clinical or radiologic evidence of disease after surgery and/or systemic treatment (by CT scan of chest, abdomen and pelvis and bone scan or PET...
You likely can't join if
- Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study. Patients who have had surgery within 4 weeks.
- Patients who have received capecitabine or who are on warfarin
- Patients who had their final breast surgery more than 12 weeks prior to study start.
- Phase Ib: patients who have not received neoadjuvant immunotherapy and/or do not plan to continue treatment with immunotherapy for at least the first...
- Objective evidence of breast cancer.
- Metastatic disease
See the full eligibility criteria
- Patients must have histologically confirmed breast malignancy that is Triple negative tumors as defined as ER and PR \<1% and HER2 negative as per ASCO/CAP guidelines
- The patient must have completed standard neoadjuvant chemotherapy which constitutes at least 6 cycles of chemotherapy.
- Phase Ib: Patients must have residual invasive carcinoma, at minimum in one of the following capacities: (1) node positive disease after treatment without residual invasive carcinoma in the breast; (2) RCB 2 or RCB 3...
- At least two weeks must have elapsed from last chemotherapy or radiation therapy. At least 4 weeks must have elapsed from most recent surgery.
- No clinical or radiologic evidence of disease after surgery and/or systemic treatment (by CT scan of chest, abdomen and pelvis and bone scan or PET scan prior to enrollment).
- Previous treatment with capecitabine is not allowed.
- Because no dosing or adverse event data are currently available on the use of TM in patients \<18 years of age, children are excluded from this study.
- KPS 90 or 100.
- Life expectancy of greater than 3 months.
- Patients must have normal organ and marrow function as defined below:
- hemoglobin \>10mg/dL
- absolute neutrophil count \>1,500/ µL
- platelets \>100,000/µL
- total bilirubin \<1.5 x normal institutional limits
- AST (SGOT)/ALT (SGPT) \<1.5 X institutional upper limit of normal
- Antiresorptive therapy and denosumab may be administered.
- Patients must be on stable medical therapy for at least 2 weeks if they are being treated medically for their chemotherapy induced peripheral neuropathy.
- The effects of TM on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence)...
- Ability to understand and the willingness to sign a written informed consent document.
- Normal B12 levels.
- Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study. Patients who have had surgery within 4 weeks.
- Patients who have received capecitabine or who are on warfarin
- Patients who had their final breast surgery more than 12 weeks prior to study start.
- Phase Ib: patients who have not received neoadjuvant immunotherapy and/or do not plan to continue treatment with immunotherapy for at least the first cycle of study treatment.
- Objective evidence of breast cancer.
- Metastatic disease
- Carcinomatous meningitis or active parenchymal brain metastases.
- Estimated creatinine clearance \< 60 ml/min
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to TM or capecitabine.
- Pregnant women are excluded from this study because TM has the potential to have teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to...
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti- retroviral therapy are excluded from the...
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Lebanon, New Hampshire, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; Lebanon, New Hampshire, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.