RecruitingPhase 2Phase 3NCT04576143

Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer

Efficacy and Safety of Dose-dense Epirubicin and Cyclophosphamide Plus Paclitaxel as Neoadjuvant Chemotherapy for HER2-negative Early Breast Cancer：a Multicenter Randomized Controlled Trial

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

260 participants

Start Date

Sep 20, 2020

Study Type

INTERVENTIONAL

Conditions

HER2-negative Breast Cancer Neoadjuvant Chemotherapy

Summary

Recent clinical studies showed that breast cancer patients especially for those with lymph node metastasis may benefit from dose-dense chemotherapy, like adriamycin and cyclophosphamide (AC) q2w×4→ paclitaxel (P) q2w×4. However, the studies on dose-dense (dd) regimen chemotherapy is mostly based on postoperative adjuvant chemotherapy and the optimum of dose-dense chemotherapy has not been determined for Chinese population with HER2-negative breast cancer patients. In our study, a prospective, randomized, open-label, multi-center clinical study was conducted to compare the efficacy and safety of dose-dense chemotherapy regimen (dd epirubicin/cyclophosphamide (EC) followed by dd paclitaxel (P)) and conventional chemotherapy (epirubicin/cyclophosphamide (EC) followed by docetaxel (T)) as preoperative neoadjuvant chemotherapy in the treatment of HER2-negative breast cancer in Chinese population.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a dose-dense chemotherapy regimen (ddEC-ddP — meaning drugs are given more frequently than usual) as pre-surgical treatment for women with HER2-negative breast cancer. Researchers want to see if this approach can shrink tumors more effectively before surgery. **You may be eligible if...** - You are a woman aged 18–70 - You have been diagnosed with invasive HER2-negative breast cancer (stage IIA–IIIA) confirmed by biopsy - Your tumor is at least 2 cm in size - You are in good general health (ECOG score 0 or 1) - Your heart, bone marrow, liver, and kidney function are all within acceptable ranges **You may NOT be eligible if...** - Your tumor is HER2-positive - Your cancer has spread to other organs - You have already received any chemotherapy, radiation, or hormone therapy for this cancer - You have a severe infection or uncontrolled medical condition - You are pregnant or breastfeeding - You have heart failure or poor heart function (LVEF below 50%) - You have had another cancer in the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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