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Pyrotinib 320 mg orally once daily, and epirubicin 90 mg/m² or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 for four 3-week cycles followed by paclitaxel 175 mg/m² intravenously on day 1 or four 3-week cycles.

Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel

Placebo orally once daily, and epirubicin 90 mg/m² or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 for four 3-week cycles followed by paclitaxel 175 mg/m² intravenously on day 1 or four 3-week cycles.

Placebo, epirubicin or doxorubicin, cyclophosphamide, paclitaxel

Chang Gong, Prof

This is a multi-center, double blind, prospective, placebo controlled, 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) early breast cancer

Neoadjuvant Pyrotinib Versus Placebo Combined With Chemotherapy in HR-positive and HER2-low Early Breast Cancer

Neoadjuvant Pyrotinib Versus Placebo Combined With Chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) Early Breast Cancer: a Double Blind, Multi-center, Randomized Phase III Trial

Individual participant data that underlie the results reported in future research article after de-identification and the study protocol will be shared beginning 3 months and ending 5 years following publication. Proposals should be directed to gchang@mail.sysu.edu.cn and data will be shared by email

The proportion of patients with RCB 0/I after neoadjuvant therapy according to the online Residual Cancer Burden Calculator provided by the MD Anderson Cancer Center as assessed by independent central review

The proportion of patients with RCB 0/I after neoadjuvant therapy according to the online Residual Cancer Burden Calculator provided by the MD Anderson Cancer Center as assessed by local pathology review

The proportion of patients with no residual invasive tumor cells in the breast and axillary nodes, regardless of ductal carcinoma in situ

The percentage of patients who achieved a complete or partial response in breast according to the RECIST, version 1.1, based on MRI, at the end of cycle 2 neoadjuvant therapy and at the end of cycle 8 neoadjuvant therapy

The proportion of patients who had successful breast conservation surgery after neoadjuvant therapy

The score of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (version 3)

The score of Breast Cancer-Specific Module (QLQ-BR23)

the time from random assignment until any relapse, unequivocal tumor progression, or any-cause death

the time from random assignment until any-cause death

General safety will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0). Ovarian toxicity will be evaluated by menstrual status and FSH and E2

The association between immune cell subpopulations quantities and RCB

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Pyrotinib Versus Placebo Combined With Chemotherapy in HR-positive and HER2-low Early Breast Cancer	NCT06144944	Breast Cancer I... Hormone-recepto... HER2 Low Breast... Early-stage Bre...	Pyrotinib, epir... Placebo, epirub...	17 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Neoadjuvant Pyrotinib Versus Placebo Combined With Chemotherapy in HR-positive and HER2-low Early Breast Cancer	NCT06144944	Breast Cancer I... Hormone-recepto... HER2 Low Breast... Early-stage Bre...	Pyrotinib, epir... Placebo, epirub...	17 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Neoadjuvant Pyrotinib Versus Placebo Combined With Chemotherapy in HR-positive and HER2-low Early Breast Cancer	NCT06144944	Breast Cancer I... Hormone-recepto... HER2 Low Breast... Early-stage Bre...	Pyrotinib, epir... Placebo, epirub...	17 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel