Recruiting soon

NeoTHERaTHP vs TCHP for HER2-positive Breast Cancer

What is being tested

Carboplatin

+ Docetaxel

+ Trastuzumab (or biosimilar)

Drug

Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years

+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: November 2025

See protocol details

Summary

Principal SponsorUniversity of Kansas Medical Center

Study ContactKUCC Navigation

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 14, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on women with early-stage breast cancer that is known to have an increased amount of a protein called HER2. The study aims to compare the effectiveness of two different treatment combinations given before surgery. One combination includes the drugs Docetaxel, Carboplatin, Herceptin, and Perjeta, while the other consists of Docetaxel, Herceptin, and Perjeta only. By comparing these treatments, the study hopes to find which combination is more effective in shrinking or eliminating the cancer before surgery, potentially leading to better outcomes for patients. Participants in this study receive one of the two treatment combinations before undergoing surgery. The treatments are administered through injections. The main goal is to see how many patients achieve a "pathological complete response," meaning no signs of cancer are found during surgery. This result can indicate how effective the treatment was in reducing the cancer. While the study does not provide specific details on risks, testing different treatment combinations can help identify the most beneficial approach with the least side effects for future patients.

Official TitleA Randomized Trial of Neoadjuvant THP vs TCHP for HER2-amplified/Positive Breast Cancer (NeoTHERa)

NCT07220135

Principal SponsorUniversity of Kansas Medical Center

Study ContactKUCC Navigation

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

14 inclusion criteria required to participate

Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent

18 years of age or older

Histologically confirmed cT2-T3 N0-N2, cT1 N1-N2, or cTX N1-N2 HER2 positive breast cancer (The invasive tumor must be HER2-positive based on the current ASCO-CAP guidelines; Patients are eligible regardless of estrogen receptor (ER) or progesterone receptor (PR) expression status. However, percentage of both ER and PR positivity must be documented in the pathology report.)

No previous ipsilateral breast surgery for the current breast cancer

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7 exclusion criteria prevent from participating

Current or anticipated use of other investigational agents while participating in this study

Clinically or radiographically detected metastatic disease

Inflammatory breast cancer

Prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen. Note: Patients with squamous cell or basal cell carcinoma of the skin, ductal carcinoma in situ (DCIS) of the breast, or carcinoma in situ (CIS) of the uterine cervix who have undergone definitive therapy are not excluded from participation

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Carboplatin and docetaxel plus trastuzumab and pertuzumab every 21 days for 6 cycles. Doses and route of administration per institutional standards.

Group II

Docetaxel plus trastuzumab and pertuzumab every 21 days for 6 cycles. Doses and route of administration per institutional standards.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers