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New treatment option for Breast Cancer (Triple Negative Breast Cancer (TNBC))
Official title Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy
ClinicalTrials.gov ID: NCT07555210
What this study is testing
- What it's testing
- Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells. However, these agents, now approved for over 15 types of cancers and for both early-stage and metastatic disease, are capable of causing inflammation in any organ system of the body that can lead to organ damage, dysfunction, and even death in rare cases.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- Patients planning to start or within the first four weeks of treatment with anti-PD-1 immune checkpoint inhibitor therapy either alone or in...
- Life expectancy of at least 12 months per the discretion of the treating physician.
You likely can't join if
- Patients ineligible for anti-PD-1 therapy.
- Patients with metastatic disease.
- Patients planning treatment with dual immune checkpoint inhibitor therapy.
- Bony fractures in the pelvis, bilateral hips/femurs, thoracic spine, or lumbar spine.
- Known osteoporosis or osteopenia.
- Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months.
See the full eligibility criteria
- Age ≥ 18 years.
- Patients planning to start or within the first four weeks of treatment with anti-PD-1 immune checkpoint inhibitor therapy either alone or in combination with chemotherapy for curative intent for a known cancer diagnosis...
- Life expectancy of at least 12 months per the discretion of the treating physician.
- Patients ineligible for anti-PD-1 therapy.
- Patients with metastatic disease.
- Patients planning treatment with dual immune checkpoint inhibitor therapy.
- Bony fractures in the pelvis, bilateral hips/femurs, thoracic spine, or lumbar spine.
- Known osteoporosis or osteopenia.
- Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months.
- Parathyroid gland disorders, rheumatoid arthritis (unless well-controlled off active biologic therapy without chronic steroid use), CKD stage IV/V, or ESRD.
- Inability to comply with study procedures.
- Inability to lie flat for 20-25 minutes during an imaging session.
- Pregnant or breastfeeding patients.
- Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, 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.