NeoADAPTA Pilot Study of Neoadjuvant Response-Adapted Chemotherapy With Pembrolizumab in Patients With Stage 2 and 3 Triple Negative Breast Cancer to Determine Early PET and Biomarker Dynamics
Paclitaxel
+ Carboplatin
+ Pembrolizumab
Breast Diseases+4
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: May 1, 2024
Actual date on which the first participant was enrolled.This clinical trial is focusing on patients diagnosed with stage 2 and 3 triple-negative breast cancer. The study aims to explore a treatment approach that uses a combination of chemotherapy drugs paclitaxel, carboplatin, and pembrolizumab, followed by an evaluation of how the cancer responds early on through imaging and biomarker analysis. This kind of cancer is known for being aggressive and difficult to treat, so finding effective treatment strategies is crucial. By adapting the treatment based on early detection of response, the study hopes to improve the outcomes for people facing this challenging diagnosis. Participants in this study begin with initial tests, including bloodwork, MRI, and PET scans, to establish a baseline. They then receive the treatment drugs through an intravenous infusion. After the first cycle, the same tests are repeated to monitor changes. If the cancer appears to respond well, the patient proceeds to surgery. If not, additional treatments are given before surgery. Throughout the study, periodic blood samples are collected to track cancer DNA changes. After surgery, depending on the cancer's response, further treatment options are considered, which might include additional medication. This approach aims to tailor treatment to each individual's cancer response, potentially increasing the effectiveness of the therapy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible 2. Age ≥ 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 4. Eligible for standard chemo-immunotherapy as determined by treating physician, including consideration of: 1. Adequate marrow and organ function 2. Co-morbid conditions do not preclude the use of chemo-immunotherapy (such as uncontrolled autoimmune disease, or the use of immunosuppressive medications) 5. Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study Exclusion Criteria: 1. Patients unable to undergo PET or MRI 2. Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence) 3. Inflammatory breast cancer 4. Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United StatesOpen Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Google MapsSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United States