Patients With HER2-positive Advanced Breast Cancer Treated With T-DXdPRO-NEPANCT07132749
NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd
An observational study of Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd and Patients With HER2-low Advanced Breast Cancer Treated With T-DXd, run by Yeon Hee Park at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd, Patients With HER2-low Advanced Breast Cancer Treated With T-DXd
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2025to 30 Sep 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 14Show fewer
- 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:
- 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.
- Total hysterectomy (surgical removal of the uterus and cervix) or tubal ligation (getting your "tubes tied") at least six weeks before taking study treatment.
- 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.
- Combination of the following:
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
Read the 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).
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | advanced breast cancer patients receiving at least 2 cycles of T-DXd. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR: no emesis and no rescue medication)
CR during the long-delayed phase(>120-504 hours)
Measured: 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)
CR during the acute phase (0-24 hours), delayed phase (>24-120 hours), overall phase (0-120 hours), extended overall phase (0-504 hours)
Measured: 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)
CC during the acute phase (0-24 hours), delayed phase (>24-120 hours), overall phase (0-120 hours), long-delayed phase (>120-504 hours), and extended overall phase (0-504 hours)
Measured: 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)
TC during the acute phase (0-24 hours), delayed phase (>24-120 hours), overall phase (0-120 hours), long-delayed phase (>120-504 hours), and extended overall phase (0-504 hours)
Measured: 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)
NSN during the acute phase (0-24 hours), delayed phase (>24-120 hours), overall phase (0-120 hours), long-delayed phase (>120-504 hours), and extended overall phase (0-504 hours
Measured: At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks
No nausea
No nausea during the acute phase (0-24 hours), delayed phase (>24-120 hours), overall phase (0-120 hours), long-delayed phase (>120-504 hours), and extended overall phase (0-504 hours)
Measured: At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks
CR rate
Daily CR rate
Measured: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
NSN rate
Daily NSN rate
Measured: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
no nausea rate
Daily no nausea rate
Measured: 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
Proportion of patients who receive rescue medications
Measured: 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
Proportion of patients undergoing T-DXd dose delay due to nausea and/or vomiting
Measured: 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
Proportion of patients requiring permanent discontinuation of T-DXd due to nausea and/or vomiting
Measured: 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)
- Range of EQ-5D index Minimum-Maximum Range: approx.-0.28 to -0/17 ~ 1,000
- Range of EQ VASMinimum-Maximum Range: 0~100 *The higher to score, the better the health status.
Measured: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks
FACIT Fatigue
Proportion of patients experiencing fatigue and severity of fatigue (FACIT Fatigue) (1) Range of FACIT Fatigue scale Minimum-Maximum Range 0~52
*Higher score indicate less fatigue and better health status.
Measured: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks
CTCAE v5.0
Safety evaluated according to CTCAE v5.0, higher scores mean a worse outcome
Measured: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks
Daily rescue medication rate
Daily rescue medication rate
Measured: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
Duration of rescue medication
Duration of rescue medication
Measured: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start12 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With HER2-positive Advanced Breast Cancer Treated With T-DXdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Yeon Hee Park
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinn Healthcare SA
- Responsible party
- Sponsor-investigator, Yeon Hee Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132749
- Sponsor's protocol ID
- 2025-04-119
- Acronym
- PRO-NEPA
- Status last verified
- Jan 2026
- First submitted
- 4 Aug 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be decided later.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07132749
- Acronym / sponsor ID
- PRO-NEPA / 2025-04-119
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yeon Hee ParkUniversity, hospital or other
- Collaborators
- Helsinn Healthcare SA
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –advanced breast cancer patients receiving at least 2 cycles of T-DXd. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
CR during the long-delayed phase(>120-504 hours)
16 secondary outcomes
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
FACIT Fatigue
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
CTCAE v5.0
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
Daily rescue medication rate
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
Duration of rescue medication
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided. It will be decided later.
Related trials for Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd and Patients With HER2-low Advanced Breast Cancer Treated With T-DXd, run by Yeon Hee Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.