Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer (NCT04872985) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer
China140 participantsStarted 2021-04-20
Plain-language summary
This is a Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel as neoadjuvant therapy for women with hormone receptor positive HER2-negative stage II to III breast cancer. Patients randomized to the study arm/control arm will receive standard neoadjuvant chemotherapy in combination with pyrotinib/placebo, respectively. The primary endpoint of the study is the residual cancer burden 0/I (RCB 0/I) and total pathological complete response (tpCR) rate. Secondary endpoints include the breast pCR (bpCR) rate, objective response rate(ORR), event-free survival (EFS), overall survival (OS), rate of change in the Ki-67 proliferation index, correlations between potential biomarkers and treatment efficacy, and toxicity.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Presenting with histological(by core needle biopsy or by limited incisional biopsy) proven hormone receptor positive (ER≥10% and/or PR ≥1%), HER2 negative(IHC ≤2+ and/or FISH-) , stage II/ III breast cancer.
* Have clinical indication for neoadjuvant therapy.
* HER4 IHC score ≥ 4.
* Measurable disease (breast and/or lymph nodes).
* The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
* Adequate bone marrow function (within 4 weeks prior to registration): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l.
* Adequate liver function (within 4 weeks prior to registration): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL.
* Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be ≥50 ml/min.
* Patients must have the ability to swallow oral medication.
* Without history of any kind of treatment to known malignancy (solid tumor or hematologic).
* Written informed consent.
* Accessible for treatment and follow-up.
Exclusion Criteria:
* Evidence of stage IV breast cancer.
* Contralateral invasive breast cancer or Inflammatory breast cancer.
* History of non-breast malignancies (except for in situ cervical cancers, basal cell carcinoma of the skin, squamous cell carcinomas of the skin or thyroid papillary carcinoma that had received curative treatment before enrollment) within 5 years prior to randomizatio…
What they're measuring
1
RCB 0/I (Residual cancer burden 0/I) rate
Timeframe: At the time of surgery
2
tpCR (total pCR) rate
Timeframe: At the time of surgery.
Trial details
NCT IDNCT04872985
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University