Using PET scans to guide treatment for triple negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on patients with stage 2 and 3 triple negative breast cancer (TNBC) who will receive a combination of paclitaxel, carboplatin, and pembrolizumab as neoadjuvant therapy. Participants will undergo PET scans and MRIs at various stages to assess their response to treatment. Those achieving a complete clinical response will proceed to surgery, while those with residual disease will receive additional neoadjuvant therapy before surgery. The study aims to optimize treatment based on individual responses to therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Cesar A Santa-Maria, MD
• Email: csantam2@jhmi.edu
• Phone: 410-614-0874

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two treatments for low-risk triple-negative breast cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.