Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03013504 | A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients | PHASE3 | COMPLETED | 503 | — | — | Feb 19, 2018 | Jan 13, 2022 | Nov 6, 2024 | 15 | Belarus, Bulgaria +11 |
To compare the total pathological complete response rate (tpCR) in patients treated with HD201 plus chemotherapy to that in patients treated with Herceptin® plus chemotherapy.
| Arm | Type | Description |
|---|---|---|
| HD201 in combination with docetaxel | EXPERIMENTAL | 8 mg/kg i.v. loading dose over 90 mins in Cycle 1 and 6 mg/kg i.v. dose every 3 weeks over 60 mins then 30 mins for subsequent cycles (cycles 2-8), followed by surgery, then adjuvant period of 8mg/kg i.v. loading dose over 90 mins in cycle 9, and subsequent 6mg/kg (if therapy is missed by \>1 week, a re-loading dose of 8mg/kg should be given) over 30 mins for subsequent 9 cycles (cycles 10-18), disease progression, unacceptable toxicity, non-compliance, or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever occurs first. Neoadjuvant chemotherapy: Cycles 1-4: Docetaxel 75 mg/m² on day 1 of each 3-weeks cycle via 1h i.v. Infusion Cycles 5-8: EC on day 1 of each 3-weeks cycle: Epirubicin 75 mg/m² via 3-30 mins i.v. Infusion, Cyclophosphamide 500 mg/m² via 3-30 mins i.v. Infusion |
| Herceptin® in combination with docetaxel | ACTIVE_COMPARATOR | 8 mg/kg i.v. loading dose over 90 mins in Cycle 1 and 6 mg/kg i.v. dose every 3 weeks over 60 mins then 30 mins for subsequent cycles (cycles 2 -8) for cycles 2-8, followed by surgery, and subsequent adjuvant period of 8mg/kg i.v. loading dose over 90 mins in cycle 9, then 6mg/kg (if therapy is missed by \>1 week, a re-loading dose of 8mg/kg should be given) over 30 mins for subsequent 9 cycles (cycles 10-18), disease progression, unacceptable toxicity, non-compliance, or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever occurs first. Neoadjuvant chemotherapy: Cycles 1-4: Docetaxel 75 mg/m² on day 1 of each 3-weeks cycle via 1h i.v. Infusion Cycles 5-8: EC on day 1 of each 3-weeks cycle: Epirubicin 75 mg/m² via 3-30 mins i.v. Infusion, Cyclophosphamide 500 mg/m² via 3-30 mins i.v. Infusion |
| Name | Type | Description |
|---|---|---|
| HD201 | DRUG | Loading dose of 8mg/kg in Cycle 1 and 6mg/kg in subsequent cycles. |
| Herceptin | DRUG | Loading dose of 8mg/kg in Cycle 1 and 6mg/kg in subsequent cycles. |
| Docetaxel | DRUG | 75mg/m2 via i.v. infusion during cycles 1 to 4. |
| Epirubicin | DRUG | 75 mg/m2 via i.v. infusion during cycles 5-8. |
| Cyclophosphamide | DRUG | 500 mg/m2 via i.v. infusion during cycles 5-8. |
Inclusion Criteria: 1. Able and willing to give written informed consent. 2. Females ≥ 18 years of Age 3. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) \< 2. 4. Known Hormone receptor (oestrogen receptor and progesterone receptor) status. 5. HER2 overexpressed as assessed by ...