Recruiting

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

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What is being tested

Paclitaxel

+ Carboplatin

+ Pembrolizumab

Drug
Who is being recruted

Breast Diseases+4

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ContactCesar A Santa-Maria, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA 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
NCT06245889
Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ContactCesar A Santa-Maria, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesTriple Negative Breast Neoplasms

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.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
4 cycles of paclitaxel/carboplatin/pembrolizumab

Study 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

Recruiting

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, United StatesOpen Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Google Maps
Recruiting

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, United States
Recruiting
2 Study Centers