Actively Recruiting
Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2021-08-12
260
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
W
Women's Hospital School Of Medicine Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18-70 years old
- Histologically confirmed unilateral invasive breast carcinoma, clinical stage IIA-IIIA
- HER2-negative status confirmed by immunohistochemistry or in situ hybridization
- At least one measurable tumor focus larger than 2 cm according to RECIST 1.1
- ECOG performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) of 55% or higher
- Normal bone marrow function: white blood cell count > 4 x 10^9/l, neutrophil count > 1.5 x 10^9/l, platelet count > 100 x 10^9/l, hemoglobin ≥ 9 g/dl
- Normal liver and kidney function: AST and ALT ≤ 2.5 times upper limit, total bilirubin ≤ 1.5 times upper limit, serum creatinine ≤ 1.5 times upper limit
- Signed informed consent form
You will not qualify if you...
- HER2-positive breast cancer
- Presence of metastasis at any location
- Previous neoadjuvant therapy including chemotherapy, radiotherapy, or hormone therapy
- Severe systemic disease or uncontrollable infection preventing study participation
- Known allergy or intolerance to chemotherapy drugs used in the study
- History of malignant tumors in the past 5 years except basal cell carcinoma and cervical carcinoma in situ, including contralateral breast cancer
- Cardiovascular disease with LVEF below 50% or New York Heart Association grade 2 or higher
- Pregnant or breastfeeding women; positive pregnancy test before treatment; women of childbearing age refusing contraception during treatment and 8 weeks after
- Participation in other clinical trials
- Investigator judgment deeming participant unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yiding Chen
CONTACT
H
Huihui Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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