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RecruitingPhase 2

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

A 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans, MRI scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "A PET scan will be performed at baseline and after 1 cycle of therapy."
  • "A breast MRI will be performed after treatment completion."
  • "Eligible participants will undergo baseline procedures including research bloodwork, MRI and PET scan."
  • "At the end of Cycle one patients will undergo repeat procedures (bloodwork and PET scan), and then continue with treatment for an additional three cycles. ctDNA will be collected on day 1 of each cycle."
  • "At the end of treatment patients will undergo repeat MRI."
  • "Patients achieving a clinical complete response (CR) on MRI will proceed with surgery."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with stage 2 or 3 triple-negative breast cancer (TNBC). It looks at PET scans before and early in treatment with chemotherapy and pembrolizumab, a drug that helps the immune system fight cancer. Patients get an MRI after treatment, and those with signs of cancer still present get more chemotherapy before surgery.

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. A breast MRI will be performed after treatment completion. Patients with complete clinical response will proceed to surgery. Patients with clinical residual disease will complete neoadjuvant rescue with 4 cycles of doxorubicin/cyclophosphamide prior to surgery. If residual disease identified after surgery, adjuvant therapy to be determined by the treating oncologist (may include doxorubicin/cyclophosphamide/pembrolizumab, capecitabine etc).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage 2 or 3 triple-negative breast cancer. Estrogen and progesterone receptor test results of 10% or less are allowed.
  • Be at least 18 years old.
  • Be able to care for yourself and be up and about for at least half the day (ECOG score 0 to 2).
  • Your doctor must decide that you can receive standard chemotherapy and immune treatment, based on blood cell and organ function, other health problems, and medicines you take.
  • Be able to understand the study and willing to sign a consent form before joining.

Who can't join

  • Cannot have a PET scan or MRI.
  • Have cancer that has spread to distant parts of the body, or breast cancer that has come back in the breast area or nearby tissues, such as the chest wall.
  • Have inflammatory breast cancer, a type that can make the breast red and swollen.
  • Have had paclitaxel, carboplatin, or immune checkpoint inhibitors, a type of drug that helps the immune system fight cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 sites (2)

MD