CompletedPhase 1/2

Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

South Korea28 participantsStarted 2017-10-30

Plain-language summary

To assess the safety and establish the dose to assess the pharmacokinetic activity following administration of EC-18 in patients with advanced breast cancer receiving low febrile neutropenia risk chemotherapy who are the candidates for second-line or higher combination therapy with doxorubicin and cyclophosphamide.

Who can participate

Age range

19 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Women ≥19 years of age
. Subjects who have voluntarily signed the informed consent prior to the screening tests to participate in the study
. Subjects who have been diagnosed as adenocarcinoma of the breast and relapsed after adjuvant or primary (neoadjuvant) chemotherapy, and was confirmed based on documented medical history to be candidates for second-line or higher combination chemotherapy with doxorubicin and cyclophosphamide to treat relapsed or metastatic disease.
. Subjects with adequate function of major organs based on the following clinical laboratory values in the latest test performed within 28 days prior to IP dosing:
. Subjects whose Eastern Cooperative Oncology Group (ECOG) performance score is 0-1.
. For women of child bearing potential, subjects should have willingness to use acceptable contraceptive methods during the entire clinical study period.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of Grade 4 neutropenia

Timeframe: 15 days after starting chemotherapy

Trial details

NCT IDNCT03104595

SponsorEnzychem Lifesciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-26

View on ClinicalTrials.gov More Febrile Neutropenia trials

Plain-language summary

Who can participate

Age range

19 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Women ≥19 years of age
. Subjects who have voluntarily signed the informed consent prior to the screening tests to participate in the study
. Subjects who have been diagnosed as adenocarcinoma of the breast and relapsed after adjuvant or primary (neoadjuvant) chemotherapy, and was confirmed based on documented medical history to be candidates for second-line or higher combination chemotherapy with doxorubicin and cyclophosphamide to treat relapsed or metastatic disease.
. Subjects with adequate function of major organs based on the following clinical laboratory values in the latest test performed within 28 days prior to IP dosing:
. Subjects whose Eastern Cooperative Oncology Group (ECOG) performance score is 0-1.
. For women of child bearing potential, subjects should have willingness to use acceptable contraceptive methods during the entire clinical study period.

Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria