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

NCT ID: NCT04767828

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-06-30

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.

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 natural course of the disease is extremely short. At present, the main treatment of brain metastases from breast cancer is radiotherapy, combined with chemotherapy and targeted therapy drugs. On the basis of previous clinical studies, the aim of this study was to explore the efficacy and safety of combined brachytherapy with Pyrrotidine and Capecitabine in patients with brain metastases from HER2-positive breast cancer, in order to provide a new, safer and more effective treatment for patients with brain metastases from breast cancer.

Conditions

TTP

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One arm exploratory research

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)

Group Type: EXPERIMENTAL

PYRROTINI

Intervention Type: 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) .

Brain radiation therapy

Intervention Type: RADIATION

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

Interventions

PYRROTINI

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) .

Intervention Type: DRUG

Brain radiation therapy

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

Intervention Type: RADIATION

Other Intervention Names

CAPECITABINE

Eligibility Criteria

Inclusion Criteria

1. Signed written informed consent prior to enrollment.

2. Age 18-75 years, female.

3. 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).

4. The presence of CNS lesions as confirmed by cranial CT or MRI.

5. ECOG score: 0 to 2.

6. Expected survival of not less than 12 weeks.

7. having received no previous brain radiotherapy or having received brain radiotherapy at the dose specified in the trial protocol.

8. Patients who have been on pyrrolizidine for ≤ 3 months after diagnosis of brain metastases and whose disease has not progressed.

9. 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%

10. 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.

11. Subjects are voluntarily enrolled in the study, are compliant, and cooperate with safety and survival follow-up.

Exclusion Criteria

1. Presence of third interstitial fluid that cannot be controlled by drainage or other methods, such as massive pleural and ascites fluid.

2. 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).

3. have a proven allergy to the drug components of this regimen.

4. 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.

5. Patients with severe concomitant disease or who, in the opinion of the investigator, are not suitable for inclusion.

6. Patients with the presence of meningeal metastases.

7. having participated in a clinical trial of another drug within 4 weeks prior to enrollment.

8. 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).

9. Concurrently receiving other antitumor therapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Wang, MD

Role: PRINCIPAL_INVESTIGATOR

研究者

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Wang, MD

Role: CONTACT

wj62182@126.com

13920762182

Xuejing Liu, MD

Role: CONTACT

lxj8109@126.com

13920762182

Facility Contacts

Jing Wang, MD

Role: primary

wj62182@126.com

13920762182

Other Identifiers

E2019316

Identifier Type: -

Identifier Source: org_study_id