Health TrialsbyHealthPanel

Neratinib Combined With Fulvestrant and Eribulin in the Treatment ofHR+/HER2+ Advanced Breast Cancer

ConditionBrest Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorXijing Hospital

About this trial

This study aims to explore the efficacy and safety of neratinib combined with fulvestrant and eribulin in the treatment of HR+/HER2+ advanced breast cancer after trastuzumab deruxtecan resistance. The treatment regimen of neratinib + fulvestrant + eribulin in this study is expected to provide a new and effective therapeutic strategy for patients with triple-positive breast cancer who develop resistance to trastuzumab deruxtecan, and offer novel therapeutic insights for advanced triple-positive breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged ≥18 years and ≤75 years;

ECOG performance status of 0-2;

Definition of HER2 positivity: IHC 3+ or IHC 2+/ISH positive prior to T-DXd treatment;

Definition of HR positivity: ER or PR ≥1%;

Disqualifiers

Severe allergic reactions to neratinib, eribulin, fulvestrant, or any of their excipients;

Prior treatment with neratinib, other small-molecule anti-HER2 TKIs, or eribulin;

Patients with inflammatory breast cancer;

A history of other malignant tumors within the past 5 years or concurrent malignant tumors (including cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma);

Trial design

Design model

Single group

Treatments tested in this trial

  • Neratinib Combined with Fulvestrant and Eribulin

    Drug

    neratinib combined with fulvestrant and eribulin in the treatment of HR+/HER2+ advanced breast cancer after trastuzumab deruxtecan resistance

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Neratinib Combined with Fulvestrant and EribulinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate(ORR)

The proportion of patients whose tumor lesions achieve "Partial Response (PR)" or "Complete Response (CR)" after treatment

Time frame
From treatment initiation to disease progression, intolerable toxicity, or study completion, whichever occurs first，assessed up to 10 months

Secondary outcomes

1

progression free survival

the length of time from a patient's enrollment to the first occurrence of either "disease progression (PD)" or "death from any cause".

Time frame
From first treatment initiation to the first occurrence of disease progression (per RECIST v1.1) or death from any cause, or study completion (whichever occurs first)，assessed up to 60 months
2

overall survival

the length of time from a patient's enrollment to death from any cause

Time frame
From first treatment initiation to death from any cause or study completion, whichever occurs first, with a minimum follow-up of 12 months for surviving patients，assessed up to 100 months
3

Disease control rate

Time frame
From first treatment initiation to disease progression, intolerable toxicity, or study completion (whichever occurs first), with disease control status confirmed for ≥4 weeks per RECIST v1.1
4

duration of response

Time frame
From the first confirmed Complete Response (CR) or Partial Response (PR) (per RECIST v1.1, maintained for ≥4 weeks) to the first documented disease progression (PD) or death from any cause, or study completion，assessed up to 10 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xijing Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: