Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eribulin · 1 trial · 2 indications
Hair loss rate defined as CTCAE v5.0 alopecia grade 1 or higher compared in the scalp cooling group using the Paxman Hair Loss Prevention System (PSCS) and group not using scalp cooling.
| Arm | Type | Description |
|---|---|---|
| ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) | EXPERIMENTAL | Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with Eribulin. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years. |
| ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS) | ACTIVE_COMPARATOR | Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with Eribulin. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years. |
| SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) | EXPERIMENTAL | Participants will use Paxman Scalp Cooling System (PSCS) on days 1 and 21 of each of their standard of care (SOC) treatment cycles with SACITUZUMAB GOVITECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years. |
| SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS) | ACTIVE_COMPARATOR | Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with SACITUZUMAB GOVITECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years. |
| TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) | EXPERIMENTAL | Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with TRASTUZUMAB DERUXTECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years. |
| TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM | ACTIVE_COMPARATOR | Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with TRASTUZUMAB DERUXTECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years. |
| Name | Type | Description |
|---|---|---|
| Paxman Scalp Cooling System | DEVICE | Cap attached to coolant lines connected to a refrigeration unit placed on scalp |
| Eribulin | DRUG | Intravenous Infusion |
| Sacituzumab govitecan | DRUG | Intravenous Infusion |
| Trastuzumab deruxtecan | DRUG | Intravenous Infusion |
Inclusion Criteria: * Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2 * Participant is ≥ 18 years old. * Hair present at baseline. * One of the following full dose chemotherapy regimens must be planned for at least 4 cycles: * Sacituzumab govitecan (IMMU-132)...
Top 20 of 97 competitors