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New treatment option for Triple Negative Breast Cancer
Official title PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
ClinicalTrials.gov ID: NCT06245889
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, being studied as a potential treatment for triple negative breast cancer.
Also referred to as Taxol.
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
- Eligible patients with stage 2 and 3 triple negative breast cancer will be treated with 4 cycles of neoadjuvant paclitaxel/carboplatin/pembrolizumab. A PET scan will be performed at baseline and after 1 cycle of therapy.
- Phase 2: a mid-size study of how well it works
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, women only
You may be able to join if
- Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Eligible for standard chemo-immunotherapy as determined by treating physician, including consideration of:
- Adequate marrow and organ function
You likely can't join if
- Patients unable to undergo PET or MRI
- Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence)
- Inflammatory breast cancer
- Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors
See the full eligibility criteria
- Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Eligible for standard chemo-immunotherapy as determined by treating physician, including consideration of:
- Adequate marrow and organ function
- Co-morbid conditions do not preclude the use of chemo-immunotherapy (such as uncontrolled autoimmune disease, or the use of immunosuppressive medications)
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
- Patients unable to undergo PET or MRI
- Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence)
- Inflammatory breast cancer
- Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, 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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, 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.