PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06245889
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    chemotherapy
  • Carboplatin — DRUG
    chemotherapy
  • Pembrolizumab — DRUG
    immunotherapy
  • Doxorubicin — DRUG
    additional chemotherapy - neoadjuvant or adjuvant rescue
  • Cyclophosphamide — DRUG
    additional chemotherapy - adjuvant rescue
  • Olaparib — DRUG
    adjuvant rescue
  • Capecitabine — DRUG
    adjuvant rescue

Study Details

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).

Key Dates

Start date
May 1, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant therapy
    4 cycles of paclitaxel/carboplatin/pembrolizumab

Primary Outcome Measure

SULmax in relation to pCR [ Time Frame: 8 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287
Hopkins Breast Trials
[email protected]
410-614-1361
Cesar A Santa-Maria, M.D. (PRINCIPAL_INVESTIGATOR)
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287
JHCCCRO
[email protected]
410-955-8866

Find similar trials in Baltimore, MD

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

Related Studies