NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd

NCT07132749 | Enrolling By Invitation

• 1 other identifier: 2025-04-119
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a prospective, observational, multicenter cohort study evaluating the efficacy and safety of NEPA (netupitant/palonosetron) in patients with HER2-positive or HER2-low advanced breast cancer treated with T-DXd

Conditions

Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd; Patients With HER2-low Advanced Breast Cancer Treated With T-DXd

Keywords

HER2-positive; HER2-low; advanced breast cancer; T-DXd; NEPA; netupitant/palonosetron

Outcome Measures

Primary Outcomes (1)

• Complete response (CR: no emesis and no rescue medication)

  CR during the long-delayed phase(\>120-504 hours)

  At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks

Secondary Outcomes (16)

• Complete response (CR: no emesis and no rescue medication)

  At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks

• Complete control (CC: no emesis, no rescue medication and no or mild nausea)

  At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks

• Total control (TC: no emesis, no rescue medication and no nausea)

  At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks

• No significant nausea (NSN: defined as no or mild nausea)

  At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks

• No nausea

  At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks

Study Arms (1)

Group 1

advanced breast cancer patients receiving at least 2 cycles of T-DXd.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who had not been previously treated with T-DXd and are scheduled to receive their first cycle of T-DXd with NEPA

You may qualify if:

• Age \>19 years
• Histologically confirmed breast cancer with metastatic or locally advanced breast cancer not amenable to definitive surgery, with or without measurable disease
• Stage IV breast cancer at initial diagnosis (de novo) or progression at distant metastatic sites following curative surgery
• HER2-positive breast cancer (HER2 IHC 3+ or IHC 2+/ISH-positive) or HER2-low breast cancer (HER2 IHC 2+/ISH-negative or HER2 IHC 1+), as defined by the ASCO/CAP guidelines
• ECOG performance status 0-2
• Patients who are scheduled to initiate their first cycle of T-DXd therapy
• Patients who are scheduled to receive netupitant/palonosetron (NEPA) for the prevention of acute and delayed CINV according to the approved indications and dosage instructions
• Patients who agree to use highly effective contraception methods or not of childbearing potential. Highly effective contraception methods include:
• A. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• B. Total hysterectomy (surgical removal of the uterus and cervix) or tubal ligation (getting your "tubes tied") at least six weeks before taking study treatment.
• C. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
• D. Combination of the following:
• I. Placement of an intrauterine device (IUD) or intrauterine system (IUS) II. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
• Written informed consent

You may not qualify if:

• Patients who experienced nausea and/or vomiting within 7 days prior to the first cycle of T-DXd treatment
• Leptomeningeal metastasis and/or brain metastasis
• Patients with hypersensitivity to any components of the drug or 5-HT3 receptor antagonists.
• Pregnant women or those suspected of being pregnant, as well as breastfeeding mothers.
• Any illness or condition that, in the opinion of the Investigator, may pose unwarranted risks in administering T-DXd or NEPA to the patient.
• Patients requiring treatment with steroids, antiemetics, benzodiazepines, antipsychotics, or other contraindicated drugs, including but not limited to pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, fluvoxamine, SSRIs, SNRIs, ritonavir, or nelfinavir.

Sponsors & Collaborators

• Yeon Hee Park: lead
• Helsinn Healthcare SA: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06355, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 20, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

KR (1)