A Single Arm Study of Brain Metastasis in Patients With HER2-positive Breast Cancer

NCT04767828 | Unknown Phase 4

• 1 other identifier: E2019316
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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 combined with brain radiotherapy.

Conditions

TTP

Outcome Measures

Primary Outcomes (1)

• Time of intracranial tumor progression

  Objective to evaluate the intracranial tumor progression time of piratinib and capecitabine combined with brain radiotherapy for HER2 positive breast cancer patients with brain metastasis

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Progression-free survival

  through study completion, an average of 1 year

• Objective remission rate

  through study completion, an average of 1 year

• Duration of treatment effect

  throughout studythrough study completion, an average of 1 year

• Disease control rate

  throughout studythrough study completion, an average of 1 year

• Clinical Benefit Rate

  throughout studythrough study completion, an average of 1 year

Study Arms (1)

One arm exploratory research

EXPERIMENTAL

Brain radiation therapy: the dose and frequency of brain radiation therapy are determined by the doctor according to the patient's condition. Pyrrotini: 400 mg once a day, oral within 30 minutes after breakfast for 21 days. Cassitabine: twice a day, 800 mg / m2 orally within 30 minutes after each meal (one morning and one night, 12 hours apart, equivalent to a daily dose of 1600 mg / m2, one dose in the morning and one dose in the morning)

Drug: PYRROTINI; Radiation: Brain radiation therapy

Interventions

PYRROTINI DRUG

CAPECITABINE: 800 mg/m2 twice daily, taken orally within 30 minutes after meal (one in the morning and one in the evening, 12 hours apart, equal to a daily dose of 1600 mg/m2, with one dose in the morning and one dose in the morning) .

Also known as: CAPECITABINE

One arm exploratory research

Brain radiation therapy RADIATION

Brain radiation therapy: the dose and frequency of brain radiation therapy are determined by the doctor according to the patient's condition.

One arm exploratory research

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jing Wang, MD

  研究者

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Wang, MD

CONTACT

13920762182; wj62182@126.com

Xuejing Liu, MD

CONTACT

13920762182; lxj8109@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 23, 2021
• Study Start: May 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

CN (1)