SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHenan Cancer Hospital
About this trial
The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are:
* Does the pCR of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment? * Is the safety of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel better compared to the current standard of treatment? Researchers will compare SHR-A1811+pertuzumab or SHR-A1811+pertuzumab+albumin-paclitaxel to TCbHP to see if SHR-A1811 plus pertuzumab with or without albumin-paclitaxel works to treat early or locally advanced HER2-positive breast cancer.
Subjects will be randomly assigned 1:1:1 to：
* cohort 1：SHR-A1811 combined with pertuzumab for 6 cycles; * cohort 2：SHR-A1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles; * cohort 3：TCbHP (docetaxel, carboplatin, trastuzumab and pertuzumab) for 6 cycles.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Eligibility criteria
Qualifiers
Age: 18-70 years old, ECOG 0-1 point.
Clinical T2-T4, with any LN, M0.
HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence in situ hybridization [FISH] in the pathological test/review of the primary focus conducted by the Pathology Department of the Research Center Hospital).
Having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or MR (optional) within the first month of randomization.
Disqualifiers
Stage IV (metastatic) breast cancer.
Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease.
The patient has a second primary malignant tumor, except for fully treated skin cancer.
The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.
Trial design
Treatments tested in this trial
- SHR-A1811
- Pertuzumab
- Albumin-Paclitaxel
- Docetaxel
- Carboplatin
- Trastuzumab
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov