NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd, Patients With HER2-low Advanced Breast Cancer Treated With T-DXd. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Detailed description
The observation period of this study is until the discontinuation after administration of T-Dxd or until 8 Cycle.
* Acute phase: 0 -24 hours after T-DXd administration * Delayed phase: \>24-120 hours after T-DXd administration * Overall phase: 0-120 hours after T-DXd administration * Long-delayed phase: \>120-504 hours * Extended overall phase: 0-504 hours
Primary objectives: to evaluate the efficacy and safety of NEPA for CINV prevention in advanced breast cancer patients receiving at least 2 cycles of T-DXd across all defined assessment periods (acute, delayed, overall, long-delayed, and extended overall phases).
Primary outcome measures
- Complete response (CR: no emesis and no rescue medication) [Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks]
Secondary outcome measures (12)
- Complete response (CR: no emesis and no rescue medication) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks]
- No nausea [Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks]
- CR rate [Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks]
- NSN rate [Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks]
- no nausea rate [Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks]
- Proportion of patients who receive rescue medications [Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks]
- Proportion of patients undergoing T-DXd dose delay [Time frame: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks]
- Proportion of patients requiring permanent discontinuation [Time frame: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks]
- Health-related quality of life (EQ-5D-5L) [Time frame: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07132749 · 2025-04-119