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Scalp Cooling in MBC

Primary Purpose

Metastatic Breast Cancer, Chemotherapy-induced Alopecia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paxman Scalp Cooling System
Eribulin
Sacituzumab govitecan
Trastuzumab deruxtecan
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Breast Cancer focused on measuring Metastatic Breast Cancer, Chemotherapy-induced Alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)

ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)

SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)

SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)

TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)

TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
July 20, 2021
Last Updated
May 22, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Paxman Coolers Limited, AstraZeneca, Eisai Inc., Daiichi Sankyo, Inc., Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04986579
Brief Title
Scalp Cooling in MBC
Official Title
Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Paxman Coolers Limited, AstraZeneca, Eisai Inc., Daiichi Sankyo, Inc., Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, Chemotherapy-induced Alopecia
Keywords
Metastatic Breast Cancer, Chemotherapy-induced Alopecia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
Arm Type
Experimental
Arm Description
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.
Arm Title
ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
Arm Type
Experimental
Arm Description
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.
Arm Title
SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
Arm Type
Experimental
Arm Description
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.
Arm Title
TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Paxman Scalp Cooling System
Other Intervention Name(s)
Scalp Cooling Cap
Intervention Description
Cap attached to coolant lines connected to a refrigeration unit placed on scalp
Intervention Type
Drug
Intervention Name(s)
Eribulin
Other Intervention Name(s)
Halaven
Intervention Description
Intravenous Infusion
Intervention Type
Drug
Intervention Name(s)
Sacituzumab govitecan
Other Intervention Name(s)
Trodelvy, IMMU-132
Intervention Description
Intravenous Infusion
Intervention Type
Drug
Intervention Name(s)
Trastuzumab deruxtecan
Other Intervention Name(s)
Enhertu, DS-8201a
Intervention Description
Intravenous Infusion
Primary Outcome Measure Information:
Title
Hair Loss Rate
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Change in Patient Reported Quality of Life
Description
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).
Time Frame
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
Title
Change in Patient Reported Quality of Life
Description
Body image scale (BIS) will be used to assess patient reported positive quality of life changes using Paxman Hair Loss Prevention System (PSCS).
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elahe Salehi, DNP, ANP-BC
Phone
617-632-3800
Email
elahe_salehi@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elahe Salehi, DNP, ANP-BC
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elahe Salehi, DNP, ANP-BC
Phone
617-632-3800
Email
elahe_salehi@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Elahe Salehi, DNP, ANP-BC
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elahe Salehi, DNP, ANP-BC
Phone
617-632-3800
Email
elahe_salehi@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Elahe Salehi, DNP, ANP-BC

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Scalp Cooling in MBC

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