Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.

Eligibility criteria

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, aged 18 years or older

Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype

Disqualifiers

Pregnancy or lactation

Inmate or prisoner

Treatment with an investigational drug or other intervention throughout their breast cancer treatment

Patients with skin involvement and/or distant metastases

Trial design

Treatments tested in this trial

  • Neoadjuvant Chemotherapy
  • Radiation Therapy
  • MRI
  • Breast Cancer Surgery
  • Biopsy
  • Biospecimen collection

Treatment groups

84 Participants
are divided into 2 treatment groups

Sponsors and collaborators