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Irinotecan for Advanced and Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Irinotecan
Sponsored by
Liaoning Tumor Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age of 18-70 years;
  • Female patients with histologically or cytologically confirmed breast cancer;
  • Patients with locally recurrent or metastatic breast cancer who have been treated with at least two chemotherapy regimens;
  • Measurable lesions (based on computed tomography or magnetic resonance imaging) that have a longest diameter of ≥ 10 mm based on the RECIST v1.1 criteria and a shortest lymph node diameter of ≥ 15 mm;
  • Eastern Cooperative Oncology Group (ECOG) grade 0-2;
  • Life expectancy of ≥ 12 weeks;
  • Adequate bone marrow capacity, hepatic functional reserve, and renal functional reserve within 7 days before screening:

Absolute neutrophils count: 1.5 × 109/L Hemoglobin: ≥ 9.0 g/dL;

  • Platelet count: ≥ 80 × 109/L Total bilirubin: < 1.5 times the ULN Aspartate and alanine transaminases: ≤ 2.5 times the ULN (≤ 5 times the ULN for liver metastases) Alkaline phosphatase:< 4 times the ULN Serum creatinine: ≤ 1.5 times the ULN
  • Women of childbearing age requiring effective contraception;
  • Provision of informed consent.

Exclusion Criteria:

  • Receiving chemotherapy, radiotherapy, HER2/neu-targeted drugs (including trastuzumab), or hormonal therapy within 3 weeks;
  • Breast cancer patients who do not receive local treatment and develop brain and dural metastasis. However, patients will be eligible if corticosteroids for brain and dural metastasis have been withdrawn for at least 4 weeks, if the signs and/or symptoms of brain metastasis have been stable for ≥ 4 weeks, and if imaging findings confirm that the disease is stable between the screening and 4 weeks earlier;
  • Severe cardiovascular injury (congestive heart failure of class II or worse based on the New York Heart Association classification), unstable angina, myocardial infarction, or severe arrhythmia during the past 6 months;
  • A history of human immunodeficiency virus infection, chronic hepatitis B, or hepatitis C (high viral DNA copyl DNA ti) at the active phase;
  • Clinical evidence of other severe active infection;
  • Patients with homozygous mutations in UGT1A1*6 and/or UGT1A1*28 (these patients are susceptible to irinotecan-induced diarrhea);
  • Patients with allogeneic organ transplants that require immunosuppressive therapy;
  • A history of other malignancies within 5 years, except for cured cervical carcinoma in situ or basal cell skin cancer. Women who are pregnant, lactating, or within their childbearing age but not using adequate contraception;
  • Drug abuse and medical, psychological, or social conditions that could interfere with the patient's ability to consent or that might affect the study's results;
  • Known or suspected being allergy to the studied drug or any other drug administered in the study;
  • Any unstable condition that might jeopardize the patient's safety and compliance.

Sites / Locations

  • Cancer Hospital of China Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

124 women with locally recurrent or metastatic breast cancer who will receive treatment at 17 research centers in Liaoning Province and Heilongjiang Province of China. Irinotecan is administered intravenously on days 1 and 8 of each 3-week cycle.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
The ORR will be calculated based on the number of patients who achieve a complete or partial response divided by the total sample size.

Secondary Outcome Measures

Progression-free survival(PFS)
The PFS interval will be calculated from the start of irinotecan treatment to the first instance of tumor progression, treatment failure, or death from any cause. Overall survival will be calculated from the start of irinotecan treatment to death from any cause.

Full Information

First Posted
June 8, 2018
Last Updated
June 8, 2018
Sponsor
Liaoning Tumor Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03562390
Brief Title
Irinotecan for Advanced and Metastatic Breast Cancer
Official Title
Irinotecan for Advanced and Metastatic Breast Cancer Previously Treated Using Anthracyclines- and Taxanes-containing Regimens: Protocol for a Phase II, Open-label, Single-arm Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaoning Tumor Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial aims to evaluate the safety and efficacy of third-line or later irinotecan treatment for locally recurrent or metastatic breast cancer among Chinese patients who have received at least two regimens containing anthracyclines and taxanes.
Detailed Description
Anthracyclines and taxanes are the most effective first-line and second-line treatments for breast cancer, although increased usage in early treatment lines can make it difficult to select a third-line or later treatment. This issue is further complicated by the fact that patients with metastatic breast cancer can become resistant to anthracyclines and taxanes. Thus, there are no consistent international guidelines regarding treatment in this setting. In China, the treatment procedures for metastatic breast cancer follow the National Comprehensive Cancer Network guidelines, which recommend single-drug treatments for recurrent or metastatic disease, which typically involve anthracyclines, taxanes, vinorelbine, gemcitabine, capecitabine, and eribulin. However, there is no standard international recommendation for patients with metastatic breast cancer who have developed resistance to anthracyclines and taxanes, and there are limited options for third-line or later treatment in this setting. This trial aims to evaluate the safety and efficacy of third-line or later irinotecan treatment for locally recurrent or metastatic breast cancer among Chinese patients who have received at least two regimens containing anthracyclines and taxanes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
124 women with locally recurrent or metastatic breast cancer who will receive treatment at 17 research centers in Liaoning Province and Heilongjiang Province of China. Irinotecan is administered intravenously on days 1 and 8 of each 3-week cycle.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
The patients will receive treatment using intravenous irinotecan hydrochloride until the patient develops disease progression or fulfills a withdrawal criterion.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The ORR will be calculated based on the number of patients who achieve a complete or partial response divided by the total sample size.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression-free survival(PFS)
Description
The PFS interval will be calculated from the start of irinotecan treatment to the first instance of tumor progression, treatment failure, or death from any cause. Overall survival will be calculated from the start of irinotecan treatment to death from any cause.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18-70 years; Female patients with histologically or cytologically confirmed breast cancer; Patients with locally recurrent or metastatic breast cancer who have been treated with at least two chemotherapy regimens; Measurable lesions (based on computed tomography or magnetic resonance imaging) that have a longest diameter of ≥ 10 mm based on the RECIST v1.1 criteria and a shortest lymph node diameter of ≥ 15 mm; Eastern Cooperative Oncology Group (ECOG) grade 0-2; Life expectancy of ≥ 12 weeks; Adequate bone marrow capacity, hepatic functional reserve, and renal functional reserve within 7 days before screening: Absolute neutrophils count: 1.5 × 109/L Hemoglobin: ≥ 9.0 g/dL; Platelet count: ≥ 80 × 109/L Total bilirubin: < 1.5 times the ULN Aspartate and alanine transaminases: ≤ 2.5 times the ULN (≤ 5 times the ULN for liver metastases) Alkaline phosphatase:< 4 times the ULN Serum creatinine: ≤ 1.5 times the ULN Women of childbearing age requiring effective contraception; Provision of informed consent. Exclusion Criteria: Receiving chemotherapy, radiotherapy, HER2/neu-targeted drugs (including trastuzumab), or hormonal therapy within 3 weeks; Breast cancer patients who do not receive local treatment and develop brain and dural metastasis. However, patients will be eligible if corticosteroids for brain and dural metastasis have been withdrawn for at least 4 weeks, if the signs and/or symptoms of brain metastasis have been stable for ≥ 4 weeks, and if imaging findings confirm that the disease is stable between the screening and 4 weeks earlier; Severe cardiovascular injury (congestive heart failure of class II or worse based on the New York Heart Association classification), unstable angina, myocardial infarction, or severe arrhythmia during the past 6 months; A history of human immunodeficiency virus infection, chronic hepatitis B, or hepatitis C (high viral DNA copyl DNA ti) at the active phase; Clinical evidence of other severe active infection; Patients with homozygous mutations in UGT1A1*6 and/or UGT1A1*28 (these patients are susceptible to irinotecan-induced diarrhea); Patients with allogeneic organ transplants that require immunosuppressive therapy; A history of other malignancies within 5 years, except for cured cervical carcinoma in situ or basal cell skin cancer. Women who are pregnant, lactating, or within their childbearing age but not using adequate contraception; Drug abuse and medical, psychological, or social conditions that could interfere with the patient's ability to consent or that might affect the study's results; Known or suspected being allergy to the studied drug or any other drug administered in the study; Any unstable condition that might jeopardize the patient's safety and compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Sun
Organizational Affiliation
Cancer Hospital of China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China

12. IPD Sharing Statement

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Irinotecan for Advanced and Metastatic Breast Cancer

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