Clinical trial NCT04986579: Scalp Cooling in MBC
Official title: Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Chemotherapy-induced Alopecia
Keywords: Metastatic Breast Cancer
Chemotherapy-induced Alopecia
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Paxman Coolers Limited
name: AstraZeneca
name: Eisai Inc.
name: Daiichi Sankyo
name: Gilead Sciences
First posted: 2021-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Hair Loss Rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Change in Patient Reported Quality of Life
timeFrame: 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
measure: Change in Patient Reported Quality of Life
timeFrame: 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.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Elahe Salehi, DNP, ANP-BC
role: PRINCIPAL_INVESTIGATOR
References: