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Brief Title: AT Versus TP as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer
Official Title: A Randomized Phase 2 Trial to Assess the Efficacy of AT in Comparison to TP as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer : Evaluating the Homologous Recombination Deficiency(HRD) Biomarker
Study ID: NCT04499118
Brief Summary: This is a prospective, randomized and open-label phase II study, evaluating the efficacy and safety of AT vs TP regimen as neoadjuvant treatment for early HER2-negative breast cancer. Participants will undergo/receive HRD testing after enrollment. HRD-positive patients will be randomly assigned in a ratio of 1:1 to receive AT(Doxorubicin or Epirubicin+docetaxel)or TP(Albumin paclitaxel + Cisplatin or Carboplatin)regimen respectively, followed by surgery. HRD-negative patients will be assigned to receive TP(Albumin paclitaxel + Cisplatin or Carboplatin)regimen if TNBC, or AT(Doxorubicin or Epirubicin+docetaxel)rigemen, followed by surgery.
Detailed Description: This study intends to adopt Simon's two-stage optimal design. In stage 1, 15 HRD-positive and 15 HRD-negative patients will be recruited to receive AT or TP regimen as neoadjuvant therapy. If more than 5 patients in the HRD-positive group achieve pCR(pathological complete response) , the trial expands to stage 2, otherwise the trial terminates. In stage 2, another 31 HRD- positive and 31 HRD-negative patients will be enrolled.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of breast surgery, Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
Name: Prof. Luojing
Affiliation: Sichuan Provincial People's Hospital
Role: PRINCIPAL_INVESTIGATOR