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Trial Title:
A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer
NCT ID:
NCT06362096
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Diarrhea
Trastuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab+pyrotinib+taxene
Description:
Trastuzumab (first cycle 8mg/Kg, subsequent 6mg/Kg, iv, q3w) Pyrrotinib * po, qd, q3w The
first cycle 240mg+ montmorillonite powder, the second cycle 320mg+ montmorillonite powder
prevention Subsequent cycle 400mg+* montmorillonite powder used when necessary taxenes
Arm group label:
ARM1
Summary:
To explore a reasonable and effective way to reduce the incidence of grade 3 or above
diarrhea caused by pyrotinib
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. aged ≥ 18 years, ≤75 years
2. Her2-positive recurrent or metastatic breast cancer; Patients with local recurrence
need to be confirmed by the investigator that radical surgical resection is not
possible.
3. Did not receive any systemic antitumor therapy in the advanced stage;
4. At least one measurable lesion was present according to RECIST1.1 criteria.
5. The ECOG score is 0 to 1
6. The functional major organs must be normal
7. Volunteer to participate in this study, sign informed consent, have good compliance
and willing to cooperate with follow-up
Exclusion Criteria:
1. Have received any systematic antitumor therapy at the recurrence/metastasis stage;
2. Tyrosine kinase inhibitor (TKI) formulations targeting HER have been used at any
stage of breast cancer
3. Patients judged by the investigators to be unsuitable for systematic chemotherapy.
4. Patients with active brain metastases (meaning those requiring mannitol treatment or
with symptomatic brain metastases);
5. Had undergone major surgical procedures or significant trauma within 4 weeks prior
to randomization, or were expected to undergo major surgical treatment.
6. Serious heart disease or discomfort
7. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors
that affect the use and absorption of medications.
Gender:
All
Minimum age:
17 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Huihua Xiong
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06362096
