RecruitingPhase 2NCT05020860

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer


Sponsor

Baylor Breast Care Center

Enrollment

185 participants

Start Date

Apr 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines how well clinical response (how a tumor shrinks on imaging during treatment) correlates with the actual pathological response (what is found in the tumor tissue during surgery) in people with early-stage breast cancer receiving chemotherapy before surgery (neoadjuvant treatment). **You may be eligible if...** - You are 18 or older (men and women are eligible) - You have invasive breast cancer confirmed by biopsy - Your breast cancer is triple-negative, HER2-positive, or high-risk hormone receptor-positive (meeting at least 2 of these criteria: grade 3 tumor, age 50 or younger, low estrogen receptor score, or high Ki-67) - Your tumor is at least 2 cm on exam or imaging - You are scheduled to receive chemotherapy before surgery **You may NOT be eligible if...** - You have low-risk hormone receptor-positive breast cancer that does not meet high-risk criteria - You have already had surgery for this tumor - You have other serious medical conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel

80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle

DRUGCarboplatin

Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle

DRUGTrastuzumab

Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle

DRUGPertuzumab

Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle

DRUGDoxorubicin

60 mg/m2 IV administered on Day 1 of each 14-day cycle

DRUGCyclophosphamide

600 mg/m2 IV administered on Day 1 of each 14-day cycle

DRUGPembrolizumab

Either 200 mg IV administered on Day 1 of Cycles 1-4, or 400 mg IV administered on Day 1 of Cycles 1 and 3 of the paclitaxel/carboplatin regimen. 400 mg on Day 1 of Cycles 1 and 4 of the dose-dense AC regimen.

DRUGPertuzumab/Trastuzumab/Hyaluronidase-zzxf

Can be used in place of separate IV formulations of pertuzumab and trastuzumab. 1200 mg pertuzumab/600 mg trastuzumab/30,000 U hyaluronidase administered subcutaneously on Day 1 of the first cycle, followed by a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab/20,000 U hyaluronidase administered subcutaneously every 3 weeks.


Locations(2)

Harris Health System - Smith Clinic

Houston, Texas, United States

O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05020860


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