Breast CancerPhase 2NCT03562390
Irinotecan for Advanced and Metastatic Breast Cancer
A Phase 2 study testing Irinotecan in people with Breast Cancer, run by Liaoning Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Irinotecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
The patients will receive treatment using intravenous irinotecan hydrochloride until the patient develops disease progression or fulfills a withdrawal criterion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Apr 2017
- Primary completionJan 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Tao, Liaoning Cancer Hospital & Institute
- Investigators
- Tao Sun, Principal investigator, Cancer Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562390
- Sponsor's protocol ID
- STao-002
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03562390
- Acronym / sponsor ID
- STao-002
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Irinotecan124 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrinotecanThe patients will receive treatment using intravenous irinotecan hydrochloride until the patient develops disease progression or fulfills a withdrawal criterion. | Drug | Experimental group |
Primary outcome
Objective response rate (ORR)
Time frame: 1 year
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 secondary outcome
Progression-free survival(PFS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Sun principal investigator
Cancer Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan in people with Breast Cancer, run by Liaoning Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.