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Spots Global Cancer Trial Database for AT Versus TP as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of breast surgery, Sichuan Provincial People's Hospital, Chengdu, Sichuan, China

Contact Details

Name: Prof. Luojing

Affiliation: Sichuan Provincial People's Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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