Study of THP vs TCHP for HER2-Positive Breast Cancer
This study is looking at two standard treatment approaches for early HER2-positive breast cancer. You may be eligible if you are 18 or older and have HER2-positive breast cancer that meets certain criteria. The study compares two drug combinations: Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) versus Docetaxel, Trastuzumab, and Pertuzumab (THP). Researchers want to see which combination leads to a better "pathologic complete response" (pCR), meaning no signs of cancer are found in the breast and lymph nodes at the time of surgery. This study is currently unclear on its recruitment status and plans to enroll 100 participants.
- Study design
- This is a randomized phase II study comparing two treatment regimens. It plans to enroll 100 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at the time of breast surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07220135
Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of Kansas Medical CenterInvestigator-initiated
~100 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:CarboplatinDocetaxelTrastuzumab (or biosimilar)Pertuzumab (or biosimilar)
At a glance
Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms
Measured over At time of breast surgery
Conditions
Where it's being run
8 sites across 2 statesKansas6
Missouri2
Study leadership
- Yiduo Hu, MD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
No previous chemotherapy, anti-HER2 therapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer
ECOG Performance Status 0-1 documented within 28 days prior to the start of study treatment (Appendix A)
Breast and axillary imaging (including mammogram, ultrasound and/or MRI, per standard of care) within 49 days (7 weeks) prior to treatment initiation
Subjects with clinically and/or radiographically abnormal axillary or internal mammary lymph nodes should have pathologic confirmation of disease status with image-guided biopsy or fine needle aspiration unless deemed medically unsafe
Co-enrollment in the PRO-HER2 (HSC #160944) observational registry protocol
Archival breast tumor tissue has been obtained or has been requested for use, which should include either a formalin-fixed paraffin-embedded (FFPE) block, or sixteen slides (fourteen 5-micron uncharged unstained slides plus either two H\&E slides or two 5-micron charged unstained slides) - from primary breast tumor only.
Subjects with bilateral synchronous HER2 positive breast cancer are eligible if they meet other eligibility criteria
Neuropathy: No baseline grade 2 or above neuropathy
Not pregnant, not breastfeeding, and at least one of the following applies: Not a woman of reproductive potential as defined by institutional standards; A woman of reproductive potential who agrees to follow contraceptive guidelines per institutional standards
Adequate organ function, defined as follows: Hematologic (assessed ≤ 21 days of treatment initiation): Absolute neutrophil count ≥ 1,500/μL (with the exception of patients with documented Fy(a-/b-) (Duffy null) immunophenotype, in which case absolute neutrophil count ≥1,200/uL is allowed), Platelets ≥ 100,000/μL, Leukocytes ≥ 3,000/μL, Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (must be met without erythropoietin dependency and without erythrocyte transfusion within the last two weeks); Hepatic (assessed ≤ 21 days of treatment initiation): Total bilirubin ≤ 1.5x ULN, AST(SGOT) and ALT(SPGT) ≤ 2x ULN, Serum albumin ≥ 3.0 g/dL; Cardiac (assessed ≤ 49 days of treatment initiation): Normal baseline echocardiogram or MUGA scan including LVEF ≥ 50%, per standard of care
Exclusion
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
History of allergic reactions attributed to carboplatin, docetaxel, trastuzumab, or pertuzumab
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of this study, interfere with the subject's participation for the full duration of the study, or it is not in the best interest of the subject to participate, in the opinion of the treating investigator
Pregnancy, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. There is a potential for congenital abnormalities and for this regimen to harm breastfeeding infants.
What this trial measures
- Pathologic complete response (pCR) rate in the breast and axilla in the two treatment armsAt time of breast surgery
To evaluate the pathological complete response (pCR) rate with two neoadjuvant regimens (Docetaxel+Carboplatin+Herceptin+Perjeta (TCHP) and Docetaxel+Herceptin+Perjeta (THP)) in HER2+ breast cancer.