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HD201 · 2 trials · 2 indications
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.
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin
| 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 |
| HD201 | EXPERIMENTAL | Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion |
| EU-licensed Herceptin | ACTIVE_COMPARATOR | Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion |
| US-licensed Herceptin | ACTIVE_COMPARATOR | Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous 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. |
| EU-Herceptin | DRUG | Single-dose 6mg/kg body weight by 90 minute intravenous infusion |
| US-Herceptin | DRUG | Single-dose 6mg/kg body weight by 90 minute intravenous infusion |
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 ...
HD201 is an investigational small molecule being studied for HER2 positive breast cancer. It is being developed as a potential treatment for patients with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.
HD201 is being studied in HER2 positive breast cancer, indicating it targets the HER2 pathway. The drug is designed to interfere with HER2 signaling, which is overexpressed in certain breast cancers. This targeted approach aims to inhibit tumor growth in patients whose tumors are HER2 positive.
HD201 is being developed by Prestige Consumer Healthcare Inc., a company publicly traded under the ticker symbol PBH. The company is conducting clinical trials to evaluate the safety and efficacy of HD201 in HER2 positive breast cancer and healthy volunteers.
HD201 is in Phase 3 clinical development for HER2 positive breast cancer. A Phase 3 trial has been completed, comparing HD201 to Herceptin in patients with early HER2 positive breast cancer. The drug remains investigational and is not yet approved for commercial use.
HD201 has been studied in two completed clinical trials. NCT03013504 was a Phase 3 trial in 503 female patients with HER2 positive breast cancer across multiple countries. NCT03776240 was a Phase 1 pharmacokinetic study in 105 healthy male subjects in Australia.
HD201 is not the same as Herceptin, but it is being studied as a potential biosimilar or alternative. A Phase 3 trial compared HD201 directly to Herceptin in HER2 positive breast cancer patients to evaluate efficacy, safety, and pharmacokinetics. The results of this comparison have not been disclosed.