Recruiting

Phase 2

Docetaxel & HerceptinTrial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer

Sponsor:

University of Kansas Medical Center

Code:

NCT07220135

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carboplatin

Docetaxel

Trastuzumab (or biosimilar)

Pertuzumab (or biosimilar)

Study Details

Brief summary:

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

Breast Cancer

Study ID

NCT07220135

Start date

Nov 14, 2025

Status verified date

May, 2026

Completion date

May 14, 2031

Anticipated

Primary completion date

Nov 14, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Arm A

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

other: Arm B

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

Interventions

Carboplatin

All of the treatment being received by the study participants during the course of the study is standard of care.

Docetaxel

All of the treatment being received by the study participants during the course of the study is standard of care.

Trastuzumab (or biosimilar)

All of the treatment being received by the study participants during the course of the study is standard of care.

Pertuzumab (or biosimilar)

All of the treatment being received by the study participants during the course of the study is standard of care.

Primary outcome measure

Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms [ Time Frame: At time of breast surgery ]

Central Contacts and Locations

Central contacts

KUCC Navigation

913-588-3671 kucc_navigation@kumc.edu

Locations

The University of Kansas Cancer Center (KUCC)

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Clinical Trials Nurse Navigator

913-945-7552 ctnursenav@kumc.edu

The University of Kansas Cancer Center - Westwood

Recruiting

Kansas City, Kansas, United States, 66205

Contacts

Clinical Trial Nurse Navigator

913-945-7552 ctnursenav@kumc.edu

KUCC - Indian Creek

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Nurse Navigator

913-945-7552

KUCC - Overland Park

Recruiting

Overland Park, Kansas, United States, 66215

Contacts

Nurse Navigator

913-945-7552

KUCC - Briarcliff

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Nurse Navigator

913-945-7552

KUCC - Olathe

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Nurse Navigator

913-945-7552

The University of Kansas Cancer Center - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Clinical Trial Nurse Navigator

913-945-7552 ctnursenav@kumc.edu

KUCC - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Nurse Navigator

913-945-7552

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-05-06.