Actively Recruiting
Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer
Led by University of Kansas Medical Center · Updated on 2026-05-06
100
Participants Needed
8
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized phase II study to evaluate the pathological complete response (pCR) rate with two neoadjuvant regimens (Docetaxel+Carboplatin+Herceptin/Perjeta and Docetaxel+Herceptin/Perjeta) in HER2 amplified/positive early breast cancer.
CONDITIONS
Official Title
Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability of participant or legally authorized representative to understand the study and willingness to sign informed consent
- 18 years of age or older
- Histologically confirmed HER2-positive breast cancer classified as cT2-T3 N0-N2, cT1 N1-N2, or cTX N1-N2
- No prior surgery on the same breast for the current cancer
- No previous chemotherapy, anti-HER2 therapy, immunotherapy, endocrine therapy, or radiotherapy for current breast cancer
- ECOG Performance Status of 0 or 1 within 28 days before treatment start
- Breast and axillary imaging performed within 49 days before treatment
- Abnormal lymph nodes confirmed by biopsy if clinically or radiographically suspected unless medically unsafe
- Co-enrollment in the PRO-HER2 observational registry protocol
- Archival tumor tissue from primary breast tumor obtained or requested
- Eligible if bilateral synchronous HER2-positive breast cancer and meeting other criteria
- No baseline neuropathy grade 2 or higher
- Not pregnant, not breastfeeding, and either not a woman of reproductive potential or agrees to contraceptive guidelines
- Adequate organ function including hematologic, hepatic, and cardiac measures within specified timeframes
You will not qualify if you...
- Current or planned use of other investigational agents during the study
- Presence of metastatic disease detected clinically or radiographically
- Diagnosis of inflammatory breast cancer
- Prior or concurrent cancer that could interfere with study safety or results, except certain treated skin or cervical cancers
- History of allergic reactions to study drugs (carboplatin, docetaxel, trastuzumab, pertuzumab)
- Any condition, therapy, or lab abnormality that might affect study participation or safety, per investigator judgment
- Pregnancy, breastfeeding, or planning to conceive during the study and 120 days after last treatment dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, United States, 66205
Actively Recruiting
2
The University of Kansas Cancer Center - Westwood
Kansas City, Kansas, United States, 66205
Actively Recruiting
3
KUCC - Indian Creek
Overland Park, Kansas, United States, 66211
Actively Recruiting
4
KUCC - Overland Park
Overland Park, Kansas, United States, 66215
Actively Recruiting
5
KUCC - Briarcliff
Westwood, Kansas, United States, 66205
Actively Recruiting
6
KUCC - Olathe
Westwood, Kansas, United States, 66205
Actively Recruiting
7
The University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
8
KUCC - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
Research Team
K
KUCC Navigation
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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