Irinotecan for Advanced and Metastatic Breast Cancer

NCT03562390 | Unknown Phase 2 DMC

• 1 other identifier: STao-002
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Progression-free survival(PFS)

  1 year

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Drug: Irinotecan

Interventions

Irinotecan DRUG

The patients will receive treatment using intravenous irinotecan hydrochloride until the patient develops disease progression or fulfills a withdrawal criterion.

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaoning Cancer Hospital & Institute: lead

Study Sites (1)

Cancer Hospital of China Medical University

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Tao Sun

  Cancer Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 19, 2018
• Study Start: April 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2021
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

CN (1)