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

ConditionsBreast CancerHER2-positive Breast CancerTriple Negative 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    Participants will undergo MRI

  • Breast Cancer Surgery

    Procedure/Surgery

    Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.

  • Biopsy

    Procedure/Surgery

    Participants undergo biopsy

  • Biospecimen collection

    Procedure/Surgery

    Participants undergo blood and plasma collection

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Arm A (eeCR, non-surgical)Experimental treatment 5 interventions
Group B: Arm B (non-eeCR, surgical)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Disease-Free Rate

The study endpoints of disease-free rate and locoregional control will be determined in patient follow up by utilizing MRIs, annual mammograms and clinical assessments in conjunction with ctDNA status.

Time frame
At 12 months

Secondary outcomes

1

Locoregional control

The study endpoints of disease-free rate and locoregional control will be determined in patient follow up by utilizing MRIs, annual mammograms and clinical assessments in conjunction with ctDNA status.

Time frame
At 2, 3 and 5 years
2

Disease-free survival

Survival analysis will be conducted for time to event data, and the disease control or survival rate at specific times will be estimated based on the survival analysis along with the 95% CI.

Time frame
Up to 5 years
3

Treatment related adverse events

Toxicities will be recorded using CTCAE v5.0

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

Gateway for Cancer Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: