Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer (NCT06144944) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer
China160 participantsStarted 2024-01-17
Plain-language summary
This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) high-risk early breast cancer
Who can participate
Age range17 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must participate voluntarily, sign the informed consent form, and have good compliance
* Aged ≥ 18 and ≤ 70 years old with ECOG PS score of 0-1
* Histopathological newly diagnosed, unilateral, primary invasive breast cancer
* Histopathological hormone receptor-positve ( estrogen receptor and/or progesterone receptor ≥ 10% stained cells) and HER2-low (immunochemistry 2+ with fluorescent in situ hybridization negative)
* TNM stage-IIb/III, or TNM stage-IIa with high risk (N+, G3, or MammaPrint High-risk)
* At least one evaluable target breast lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Left ventricular ejection fraction ≥ 55%, Fridericia-corrected QT interval \< 450 ms in males and \< 470 ms in females
* White blood cell count: ≥ 3.0 × 10\^9/L, absolute neutrophil count: ≥ 1.5 × 10\^9/L, platelet count: ≥ 100 × 10\^9/L, hemoglobin: ≥ 90 g/L
* Aspartate aminotransferase and alanine aminotransferase: ≤ 2.5 × ULN, alkaline phosphatase: ≤ 2.5 × ULN, blood total bilirubin: ≤ 1.5 × ULN, serum creatinine: ≤ 1.5 × ULN
* Non-menopausal or non-surgically sterilized female patients identified as non-pregnant and non-lactating and consented to contraception both during the trial and within 6 months after the last administration of the test drug
Exclusion Criteria:
* Metastatic BC, bilateral BC, occult BC, inflammatory BC, or with other malignant tumors
* Known history of hypersensitivity to the study drugs
* Patients who …
What they're measuring
1
Residual Cancer Burden 0/1 rate as assessed by independent central review
Timeframe: Within 4 weeks after surgery
Trial details
NCT IDNCT06144944
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University