Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer
Recruiting
Phase 2
Phase 3
Interventional Study
HER2-negative Breast Cancer
Neoadjuvant Chemotherapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Female
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 260 (estimated)
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial
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 determin…
Trial Locations
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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 fl…
Contacts