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OncoMatch/Clinical Trials/NCT06245889

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Is NCT06245889 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for triple negative breast cancer.

Phase 2RecruitingSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNCT06245889Data as of May 2026

Treatment: Paclitaxel · Carboplatin · Pembrolizumab · Doxorubicin · Cyclophosphamide · Olaparib · CapecitabineEligible 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).

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Allowed: ESR1 expression up to and including 10%

estrogen receptor (ER) up to and including 10% is eligible

Allowed: PR (PGR) expression up to and including 10%

progesterone receptor (PR) up to and including 10% is eligible

Disease stage

Required: Stage II, III

Stage II-III TNBC

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: taxane (paclitaxel)

Previous treatment with paclitaxel

Cannot have received: platinum-based chemotherapy (carboplatin)

Previous treatment with carboplatin

Cannot have received: checkpoint inhibitor

Previous treatment with immune checkpoint inhibitors

Lab requirements

Blood counts

Adequate marrow function

Kidney function

Adequate organ function

Liver function

Adequate organ function

Adequate marrow and organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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