Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Carboplatin
DrugAll of the treatment being received by the study participants during the course of the study is standard of care.
Docetaxel
DrugAll of the treatment being received by the study participants during the course of the study is standard of care.
Trastuzumab (or biosimilar)
DrugAll of the treatment being received by the study participants during the course of the study is standard of care.
Pertuzumab (or biosimilar)
DrugAll of the treatment being received by the study participants during the course of the study is standard of care.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Arm AOther 4 interventions
Group B: Arm BOther 3 interventions
Trial outcomes
Primary outcomes
1
Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms
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.
Time frame
At time of breast surgerySecondary outcomes
1
Residual cancer burden (RCB)
Determine residual cancer burden (RCB) 0+1 rate
Time frame
At time of breast surgery2
Assess the toxicity and tolerability of each regimen
Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Only grade 3 and higher CTCAE toxicities will be collected. Alopecia of any grade will not be collected.
Time frame
Start of study treatment (6 cycles every 21 days) until 30 days after last dose of study treatment.3
HER2DX pathological complete response (pCR) score status
Assess pathological complete response (pCR) and residual cancer burden (RCB) by HER2DX pCR score status. The HER2DX test reports three pCR Likelihood Groups for response (High, Medium and Low).
Time frame
Results of HER2DX testing are expected to be available within 3-6 weeks of submission of FFPE samples4
Recurrence-Free Survival (RFS)
RFS is defined as the time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant), or to death as a result of any cause.
Time frame
From 3- and 5-years from diagnosisSponsors and contacts
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Source ClinicalTrials.gov