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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT07217990
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Neoadjuvant Chemotherapy — DRUG
    Participants will receive standard of care neoadjuvant chemotherapy
  • Radiation Therapy — RADIATION
    Radiotherapy simulation parameters will be at the discretion of the treating physician to account for the patient's body habitus, tumor bed location, and tolerability of the prone or supine positions, however, the recommended approach will be whole-breast RT (WBRT) in the prone position, for cT1-3 N0 patients who achieve ecCR. For cT1-2 N1 patients who achieve ecCR WBRT with nodal inclusion and lymph node boost will be performed in the supine position.
  • MRI — PROCEDURE
    Participants will undergo MRI
  • Breast Cancer Surgery — PROCEDURE
    Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.
  • Biopsy — PROCEDURE
    Participants undergo biopsy
  • Biospecimen collection — PROCEDURE
    Participants undergo blood and plasma collection

Study Details

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

Key Dates

Start date
Apr 15, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (eeCR, non-surgical)
    Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who achieve an ecCR will be placed in the non-surgical arm. Participants will receive radiation therapy and routine and additional screening MRIs during follow up.
  • Experimental: Arm B (non-eeCR, surgical)
    Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who do not achieve an ecCR will be placed in the surgical arm. Participants will undergo a lumpectomy or mastectomy, receive radiation therapy, and routine follow-up.

Primary Outcome Measure

Disease-Free Rate [ Time Frame: At 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Sachin Jhawar, MD
[email protected]
Sachin Jhawar, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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