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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT04576143
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • HER2-negative Breast Cancer
  • Neoadjuvant Chemotherapy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Epirubicin — DRUG
    i.v. 90 mg/m2
  • Cyclophosphamid — DRUG
    i.v. 600 mg/m2
  • Docetaxel — DRUG
    i.v. 100 mg/m2
  • Paclitaxel — DRUG
    i.v. 175 mg/m2

Study Details

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.

Key Dates

First listed
Oct 6, 2020
Start date
Sep 20, 2020
Status verified
Jan 2021
Primary completion
Jun 20, 2023
Completion
Sep 20, 2027

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: epirubicin/CTX × 4 - docetaxel × 4, every 3 weeks a cycle
    Cycle 1-4: Epirubicin i.v. 90 mg/m2, Cyclophosphamide i.v. 600 mg/m2 (One cycle = 21 days); Cycle 5-8: Docetaxel i.v. 100mg/m2 (One cycle = 21 days) .
  • Experimental: epirubicin/CTX × 4 - paclitaxel × 4, every 2 weeks a cycle
    Cycle 1-4: Epirubicin i.v. 90 mg/m2, Cyclophosphamide i.v. 600 mg/m2 (One cycle = 14 days); Cycle 5-8:Paclitaxel i.v. 175mg/m2 (One cycle = 14 days) .

Primary Outcome Measure

pathological complete response (pCR) [ Time Frame: Following the completion of 16 weeks or 24 weeks of neoadjuvant chemotherapy Treatment. ]

Central Contacts

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