Scalp Cooling in MBC

Study Overview
=================
Brief Summary
-----------------
This research is being done to compare rates of hair loss of people with metastatic breast who use scalp cooling versus those who do not use scalp cooling after receiving standard of care treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin. The name of the study intervention involved in this study is: Paxman Scalp Cooling System

Detailed Description
-----------------
This study is a prospective, controlled, pivotal clinical investigation to assess the efficacy of the Paxman Scalp Cooling System (PSCS) at preventing hair loss in people undergoing treatment for metastatic breast cancer with either Sacituzumab govitecan (IMMU-132 or Trodelvy™), trastuzumab deruxtecan (DS-8201a or Enhertu®), or Eribulin (Halaven®). The U.S. Food and Drug Administration (FDA) has approved the Paxman Scalp Cooling System as a treatment option for preventing hair loss while patients are undergoing chemotherapy. This system has however not been specifically studied to look at its ability to prevent hair loss in patients specifically receiving sacituzumab govitecan, trastuzumab deruxtecan, or eribulin. The research study procedures include: screening for eligibility, photographs, hair loss assessments, questionnaires and study treatment including evaluations and follow up visits. Participants will receive study treatment with scalp cooling with standard of care chemotherapy treatment and will be followed for 2-4 weeks after completion of treatment with chemotherapy. It is expected that about 120 people will take part in this research study. Paxman Coolers Limited is a medical device company and is supporting this research study by providing access to the investigational device, Paxman Scalp Cooling System.

Official Title
-----------------
Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

Conditions
-----------------
Chemotherapy-induced Alopecia, Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Device: Paxman Scalp Cooling System
* Drug: Eribulin
* Drug: Sacituzumab govitecan
* Drug: Trastuzumab deruxtecan


Participation Criteria
=================
Eligibility Criteria
-----------------
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) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle Trastuzumab deruxtecan 5.4 mg/kg administered intravenously once every 3 weeks Eribulin 1.4 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle The Paxman Scalp Cooling System must be initiated with the first dose of therapy in participants that elect to participate in the scalp cooling group. Exclusion Criteria: Known hematological malignancies (i.e. leukemia or lymphoma) Known scalp metastases. Baseline alopecia (defined CTCAE 5.0 grade > 0, see Appendix B) Subjects with cold agglutinin disease or cold urticaria. Subjects who are scheduled for bone marrow ablation chemotherapy. Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/ or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, the subject may go on study at the discretion of the Principal Investigator. Subjects who have lichen planus or lupus. Participants who are receiving any additional anti-cancer agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)<br>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. | Device: Paxman Scalp Cooling System<br>* Cap attached to coolant lines connected to a refrigeration unit placed on scalp<br>* Other names: Scalp Cooling Cap;Drug: Eribulin<br>* Intravenous Infusion<br>* Other names: Halaven;|
| Active Comparator: ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)<br>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. | Drug: Eribulin<br>* Intravenous Infusion<br>* Other names: Halaven;|
| Experimental: SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)<br>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. | Device: Paxman Scalp Cooling System<br>* Cap attached to coolant lines connected to a refrigeration unit placed on scalp<br>* Other names: Scalp Cooling Cap;Drug: Sacituzumab govitecan<br>* Intravenous Infusion<br>* Other names: IMMU-132;|
| Active Comparator: SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)<br>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. | Drug: Sacituzumab govitecan<br>* Intravenous Infusion<br>* Other names: IMMU-132;|
| Experimental: TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)<br>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. | Device: Paxman Scalp Cooling System<br>* Cap attached to coolant lines connected to a refrigeration unit placed on scalp<br>* Other names: Scalp Cooling Cap;Drug: Trastuzumab deruxtecan<br>* Intravenous Infusion<br>* Other names: DS-8201a;|
| Active Comparator: TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM<br>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. | Drug: Trastuzumab deruxtecan<br>* Intravenous Infusion<br>* Other names: DS-8201a;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Loss Rate | 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. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Reported Quality of Life | The Chemotherapy-Induced Alopecia Distress Scale (CADS) [25] will be used to assess patient reported positive quality of life changes using Paxman Hair Loss Prevention System (PSCS). | Baseline, Day 1 of cycle 3, day 1 of cycle 5, and after completing therapy or at the time of disease progression whichever occurs first up to 2 years. Cycle is 21 days | 
| Change in Patient Reported Quality of Life | Body image scale (BIS) will be used to assess patient reported positive quality of life changes using Paxman Hair Loss Prevention System (PSCS). | Baseline, Day 1 of cycle 3, day 1 of cycle 5, and after completing therapy or at the time of disease progression whichever occurs first up to 2 years. Cycle is 21 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Breast Cancer, Chemotherapy-induced Alopecia