Status:
UNKNOWN
A Single Arm Study of Brain Metastasis in Patients With HER2-positive Breast Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
TTP
Eligibility:
FEMALE
18-75 years
Phase:
PHASE4
Brief Summary
The aim of this study was to evaluate the progression time and efficacy of brain tumors in patients with brain metastases from HER2-positive breast cancer treated with Pyrrolidine and Capecitabine com...
Detailed Description
Brain metastases are very common in HER2-positive breast cancer patients. The vast majority of patients with metastatic brain tumors are in advanced stages of the disease. If not treated in time, the ...
Eligibility Criteria
Inclusion
- Signed written informed consent prior to enrollment.
- Age 18-75 years, female.
- Patients with pathologically confirmed HER2 expression-positive breast cancer brain metastases; HER2 expression-positive refers to those with a standard immunohistochemical staining (IHC) test showing HER2 as 3+ and/or fluorescence in situ hybridization technique (FISH) positive (confirmed by investigator review at their trial center).
- The presence of CNS lesions as confirmed by cranial CT or MRI.
- ECOG score: 0 to 2.
- Expected survival of not less than 12 weeks.
- having received no previous brain radiotherapy or having received brain radiotherapy at the dose specified in the trial protocol.
- Patients who have been on pyrrolizidine for ≤ 3 months after diagnosis of brain metastases and whose disease has not progressed.
- The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days).
- A) Routine blood examination criteria need to be met: Hb ≥ 100 g/L; ANC ≥ 1.5×109 /L; PLT ≥ 75×109 /L B) Biochemical examination should meet the following criteria: TBIL≤1.5×ULN (upper limit of normal); ALT and AST≤2.5×ULN; ALT and AST≤5×ULN if liver metastasis; serum creatinine≤1.5×ULN, creatinine clearance≥50ml/min (based on Cockroft and Gault formula) C) Cardiac ultrasound; left ventricular ejection fraction (LVEF) ≥ 50%
- Female patients who are non-surgically sterilized or of childbearing age are required to use a medically approved form of contraception (e.g., IUD, pill, or condom) during and for 3 months after the end of the study treatment period; female patients of childbearing age who are non-surgically sterilized must have a negative serum or urine HCG test within 7 days prior to study enrollment; and must be non-lactating.
- Subjects are voluntarily enrolled in the study, are compliant, and cooperate with safety and survival follow-up.
Exclusion
- Presence of third interstitial fluid that cannot be controlled by drainage or other methods, such as massive pleural and ascites fluid.
- the presence of multiple factors that interfere with oral administration and absorption of the drug (e.g., inability to swallow, post-gastrectomy, chronic diarrhea, and intestinal obstruction).
- have a proven allergy to the drug components of this regimen.
- Patients who are known to be pregnant or planning to become pregnant, or patients of gestational age who are unwilling to use effective contraception throughout the trial period.
- Patients with severe concomitant disease or who, in the opinion of the investigator, are not suitable for inclusion.
- Patients with the presence of meningeal metastases.
- having participated in a clinical trial of another drug within 4 weeks prior to enrollment.
- Patients who have used capecitabine during the neoadjuvant/adjuvant phase of therapy are allowed to be enrolled, but those who are ineffective or cannot tolerate capecitabine during the neoadjuvant/adjuvant phase of therapy need to be excluded; patients who have used capecitabine for ≤ 3 months after brain metastasis and whose disease has not progressed can be enrolled; other drugs for which the active ingredient is 5-fluorouracil are treated as capecitabine (Note: " used capecitabine" refers to continuous standardized use of capecitabine for ≥ 2 cycles).
- Concurrently receiving other antitumor therapy.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04767828
Start Date
May 1 2020
End Date
June 1 2022
Last Update
February 23 2021
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China, 300060