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
Qualifiers
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
Treatments tested in this trial
- Carboplatin
- Docetaxel
- Trastuzumab (or biosimilar)
- Pertuzumab (or biosimilar)
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov