SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates

degree of hair loss

percentage increase in SALT score relative to baseline The SALT score is calculated as follows: 1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital. 2. For each quadrant, visually estimate the extent of hair loss, expressed as a percentage. These percentages are recorded as whole numbers (e.g., 0%, 10%, 25%, 50%, etc.). 3. Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4. A SALT score of 0 indicates no hair loss. A SALT score of 100 indicates complete hair loss across the scalp. A score of 50 or greater is generally considered indicative of severe hair loss. assessed by blinded central dermatological review.

Time frame: 3 months

Change from baseline in quality of life

Body Image Scale (BIS) questionnaire The BIS questionnaire consists of 10 items; each rated on a four-point scale from "not at all (=0) " to "very much (=3)." Items include : Feeling self-conscious about appearance Feeling less physically attractive due to disease or treatment Dissatisfaction with appearance when dressed Feeling less feminine/masculine Difficulty looking at oneself naked Feeling less sexually attractive Avoiding people because of appearance Feeling the body is less whole General dissatisfaction with the body High scores indicate higher body image.

Time frame: at each cycle of treatment + 28 days following end of treatment

Change from baseline in quality of life

Chemotherapy-Induced Alopecia Distress Scale (CADS) The CADS is a validated psychometric scale used to assess the distress experienced by patients as a result of chemotherapy-induced alopecia. It consists of 25 items divided into five domains: physical, emotional, activities, relationships, and treatment. Each item is rated by the patient on a four-point Likert scale, ranging from "not at all" (1) to "very much" (4). Higher scores indicate greater distress related to body image.

Time frame: at each cycle of treatment + 28 days after the end of treatment

Frequency, and severity of adverse events related to scalp cooling

National Cancer Institute Patient Reported Outcome-Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE).

Time frame: all along study : from first day of treatment until 6 months follow up after the last administration of study treatment or before starting any new anticancer treatment, whichever comes first

compare scalp hair loss assessment across three methods

concordance and absolute differences in SALT scores between * AI-driven analysis leveraging Belle-AI to generate precise SALT score evaluations * Local investigator assessment * Central dermatologist assessment The SALT score is calculated as follows: 1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital. 2. For each quadrant, visually estimate the extent of hair loss, expressed as a percentage. These percentages are recorded as whole numbers (e.g., 0%, 10%, 25%, 50%, etc.). 3. Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4. A SALT score of 0 indicates no hair loss. A SALT score of 100 indicates complete hair loss across the scalp. A score of 50 or greater is generally considered indicative of severe hair loss. assessed by blinded central dermatological review.

Time frame: 3 months