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

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ClinicalTrials.gov Identifier: NCT04767828
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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.

Condition or disease Intervention/treatment Phase
TTP Drug: PYRROTINI Radiation: Brain radiation therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm Study of Brain Metastasis in Patients With HER2-positive Breast Cancer Treated With Pyrrolidine Maleate and Capecitabine Combined With Brain Radiotherapy
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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)
Drug: 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) .
Other Name: CAPECITABINE

Radiation: 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.




Primary Outcome Measures :
  1. Time of intracranial tumor progression [ Time Frame: through study completion, an average of 1 year ]
    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


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: through study completion, an average of 1 year ]
    Objective to evaluate the progression free survival (PFS) of pirotinib and capecitabine combined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis.

  2. Objective remission rate [ Time Frame: through study completion, an average of 1 year ]
    objective response rate (ORR) of pirotinib and capecitabine combined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis.

  3. Duration of treatment effect [ Time Frame: throughout studythrough study completion, an average of 1 year ]
    Duration of treatment effect (DCR) of pirotinib and capecitabine It refers to the time between the first assessment of CR or PR and the first assessment of PD (Progressive Disease) or death from any causecombined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis.

  4. Disease control rate [ Time Frame: throughout studythrough study completion, an average of 1 year ]
    Objective to evaluate the disease control rate of pirotinib and capecitabine combined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis

  5. Clinical Benefit Rate [ Time Frame: throughout studythrough study completion, an average of 1 year ]
    Objective to evaluate the clinical benefit rate of pirotinib and capecitabine combined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis

  6. Overall survival [ Time Frame: through study completion, an average of 1 year ]
    Objective to evaluate the overall survival of piratinib and capecitabine combined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis

  7. Graded healing assessment [ Time Frame: through study completion, an average of 1 year ]
    Objective to evaluate the effect of pyrrolotinib and capecitabine combined with brain radiotherapy in patients with HER2 positive breast cancer with brain metastasis,The score of graded healing assessment was 0-4. The higher the score, the better the result



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04767828


Contacts
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Contact: Jing Wang, MD 13920762182 wj62182@126.com
Contact: Xuejing Liu, MD 13920762182 lxj8109@126.com

Locations
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China
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, China, 300060
Contact: Jing Wang, MD    13920762182    wj62182@126.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Principal Investigator: Jing Wang, MD 研究者
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT04767828    
Other Study ID Numbers: E2019316
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents