PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
NCT ID: NCT06245889
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2024-05-01
2030-06-30
Brief Summary
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Detailed Description
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Patients achieving a clinical complete response (CR) on MRI will proceed with surgery. Patients with clinical residual disease (RD) on MRI will be recommended a biopsy, and be recommended "rescue" neoadjuvant doxorubicin and cyclophosphamide with pembrolizumab (AC/pembro) for four additional cycles, and then proceed with surgery. Note: patients/treating physician may opt to proceed with surgery.
Archival tissue will be collected from the surgical product. Patients achieving a pathologic CR (pCR) may proceed with adjuvant pembrolizumab per standard of care, and treating physician's discretion. Patients with pathological RD may proceed with "rescue" adjuvant AC/pembrolizumab for four additional cycles (if not given neoadjuvantly), per treating physician discretion. The participants may also receive Aadjuvant capecitabine or olaparib as indicated and per treating physician's discretion.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Neoadjuvant therapy
4 cycles of paclitaxel/carboplatin/pembrolizumab
Paclitaxel
chemotherapy
Carboplatin
chemotherapy
Pembrolizumab
immunotherapy
Doxorubicin
additional chemotherapy - neoadjuvant or adjuvant rescue
Cyclophosphamide
additional chemotherapy - adjuvant rescue
Olaparib
adjuvant rescue
Capecitabine
adjuvant rescue
Interventions
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Paclitaxel
chemotherapy
Carboplatin
chemotherapy
Pembrolizumab
immunotherapy
Doxorubicin
additional chemotherapy - neoadjuvant or adjuvant rescue
Cyclophosphamide
additional chemotherapy - adjuvant rescue
Olaparib
adjuvant rescue
Capecitabine
adjuvant rescue
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Breast Cancer Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Cesar A Santa-Maria, MD
Role: STUDY_CHAIR
Johns Hopkins University
Locations
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.
Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020 Oct 10;396(10257):1090-1100. doi: 10.1016/S0140-6736(20)31953-X. Epub 2020 Sep 20.
Other Identifiers
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IRB00398141
Identifier Type: OTHER
Identifier Source: secondary_id
J2395
Identifier Type: -
Identifier Source: org_study_id
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