NCT04576143 Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer
| NCT ID | NCT04576143 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | HER2-negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2020-09-20 |
| Primary Completion | 2023-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 260 participants in total. It began in 2020-09-20 with a primary completion date of 2023-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Female aged 18-70 years old; 2. Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable), clinical stage IIA-IIIA; 3. Definite reports on ER/PR/HER2 receptor showing all HER2 negative (HER2 is 0\~1+ or 2+ but determined negative via fluorescence in situ hybridization (FISH) or chemiluminescent in situ hybridization (CISH) detected (no amplification) is defined as HER2 negative); 4. According to RECIST 1.1, there is at least one measurable objective focus, tumor size \> 2cm; 5. Eastern Cooperative Oncology Group (ECOG) performance score is 0 or 1; 6. Cardiac function: left ventricular ejection fraction (LVEF)≥55%; 7. Normal bone marrow function: White blood cell count \> 4 × 10\^9/l, neutrophil count \> 1.5 × 10\^9/l, platelet count \> 100 × 10\^9/l and hemoglobin 9g/dl; 8. Normal liver and renal function: aspartate aminotransferase (AST) and ALT ≤2.5 folds of the upper limit of normal values, total bilirubin ≤1.5 folds of the upper limit of normal values; Serum creatinine ≤1.5 folds of the upper limit of normal value. 9. Informed consent form signed. Exclusion Criteria: 1. HER2 is positive; 2. Metastasis at any location; 3. Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy; 4. Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study; 5. Known allergic or intolerable to chemotherapeutic agents; 6. Previously suffering from malignant tumors within 5 years (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer; 7. Cardiovascular disease: LVEF \<50% (echocardiography) of New York Heart Association (NYHA) ≥ grade 2; 8. Pregnant and breast-feeding women; Pregnancy test showed positive results before drug administration after enrolling in to the study; Women at childbearing age refuse to take contraception measures during the treatment and 8 weeks after completion of treatment; 9. Already enrolled into other clinical trials; 10. The researchers judged the patients who were not suitable for this study.
Contact & Investigator
Yiding Chen
PRINCIPAL INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT04576143 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying HER2-negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04576143 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04576143 currently recruiting?
Yes, NCT04576143 is actively recruiting participants. Contact the research team at ydchen@zju.edu.cn for enrollment information.
Where is the NCT04576143 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04576143 clinical trial?
NCT04576143 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Yiding Chen at 2nd Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 260 participants.
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