BridgeMD
New treatment option for Triple Negative Breast Cancer
Official title NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients
ClinicalTrials.gov ID: NCT06845319
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an once-weekly, being studied as a potential treatment for triple negative breast cancer.
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
- This is a single-arm Phase II study to assess the efficacy of a 12-18 week neoadjuvant carboplatin, paclitaxel, and pembrolizumab (CPP) regimen in a response-adaptive manner for triple-negative breast cancer (TNBC) patients who are ineligible for anthracycline-based therapy due to underlying cardiac conditions.
- 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
You may be able to join if
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Histologically confirmed triple-negative breast cancer (TNBC) or hormone receptor-low invasive breast carcinoma, with clinical anatomic Stage II or...
- Measurable or evaluable tumor in the breast larger than 1 cm, with or without axillary involvement.
- Patients with multifocal or multicentric disease are eligible, provided the dominant tumor focus is ER and/or PR ≤10% and HER2 negative.
- Female or male, age ≥18 years.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Subject is planning to participate, currently participating in or has participated in a study of an investigational agent or has used an...
- Current diagnosis of metastatic or inflammatory breast cancer.
- Patients deemed unfit to undergo curative surgery according to the standard of care.
- Patients who have concomitant and/or previous malignancies within the last 5 years. Note: Participants with basal cell carcinoma of the skin...
- History of hypersensitivity to compounds that are similar to carboplatin and paclitaxel.
See the full eligibility criteria
Who can join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Histologically confirmed triple-negative breast cancer (TNBC) or hormone receptor-low invasive breast carcinoma, with clinical anatomic Stage II or Stage IIIA/B disease as defined by the AJCC 8th Edition Breast Cancer...
- Measurable or evaluable tumor in the breast larger than 1 cm, with or without axillary involvement.
- Patients with multifocal or multicentric disease are eligible, provided the dominant tumor focus is ER and/or PR ≤10% and HER2 negative.
- Female or male, age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Medically fit to undergo curative-intent breast surgery per institutional standard of care.
- No prior chemotherapy, immunotherapy, radiation therapy, or surgery for the current breast cancer (diagnostic core or vacuum-assisted biopsies allowed).
- Ability to be followed by a cardiologist and/or primary care physician for optimization of cardiac comorbidities, as needed.
- Adequate organ function at the time of screening, defined as: a) Hematologic
- Absolute neutrophil count ≥1,500/µL.
- Platelet count ≥100,000/µL.
- Leukocytes ≥3,000/µL.
- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (without erythropoietin dependency and without packed red blood cell transfusion within 14 days prior to testing). b) Renal a. Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50...
- AST (SGOT) and ALT (SGPT) ≤2.5 × ULN.
- Serum albumin ≥3.0 g/dL.
- Participants without a history of Gilbert's syndrome must meet one of the following: i. Total bilirubin ≤1.5 × IULN, or ii. Total bilirubin \>1.5 × IULN with direct bilirubin ≤ULN. d. Participants with a history of...
- Breast and axillary imaging (including ultrasound and MRI) within 42 days (6 weeks) prior to registration.
- Patients with clinically and/or radiologically abnormal axillary lymph nodes must have pathological confirmation with image-guided core biopsy or fine needle aspiration showing metastatic carcinoma.
- Patients should undergo staging scans to exclude metastatic disease if any of the following apply: a) Axillary imaging shows two or more abnormal lymph nodes, or b) There are clinical signs or symptoms concerning for...
- Patients with bilateral breast cancer are eligible if both tumors are HER2 negative and all other eligibility criteria are met (eligibility should be determined based on the higher-risk side when applicable).
- Baseline peripheral neuropathy grade ≤2 (per CTCAE).
- An individual of childbearing potential must be willing and able to use highly effective contraception from the time of informed consent, throughout study treatment, and for at least 6 months after the last dose of...
- Ability and willingness to comply with all study procedures, including scheduled visits, treatment plans, laboratory tests, and other study requirements.
- Ability and willingness to sign and date written informed consent prior to initiation of any study-specific procedures.
- Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6...
- Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if...
- Participants with a history of hepatitis C virus (HCV) must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results...
- Patient is ineligible for anthracycline treatment due to at least one of the following of A, B, C, or D:
- Individuals identified as being at high risk for cardiotoxicity from anthracycline treatment have one or more of the following characteristics. 1\. Preexisting cardiomyopathy with ejection fraction (EF) between 25-49%...
What rules you out
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Subject is planning to participate, currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Current diagnosis of metastatic or inflammatory breast cancer.
- Patients deemed unfit to undergo curative surgery according to the standard of care.
- Patients who have concomitant and/or previous malignancies within the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., ductal...
- History of hypersensitivity to compounds that are similar to carboplatin and paclitaxel.
- Has received major surgery and has not recovered adequately from the toxicity and/or complications before starting study treatment.
- Subject has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken...
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy (7-day clearance period for...
- Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Has a history of solid organ transplant.
- Has a history of non-infectious pneumonitis that required high-dose steroids and/or has current pneumonitis.
- Has an active bacterial infection requiring systemic therapy.
- Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial.
- Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment.
- Subject is a WOCBP who has had a positive urine pregnancy test within 24 hours prior to initiation of study treatment. Females will be determined to be not of child-bearing potential with a history of hysterectomy or...
- Uncontrolled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg), or uncontrolled or symptomatic arrhythmia at the time of screening visit.
- At the time of the screening visit, EF is less than 25%.
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Charleston, South Carolina, 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.