Metastatic Breast CancerPhase 2NCT01784120
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
A Phase 2 study testing Doxorubicin/Genexol-PM in people with Metastatic Breast Cancer, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer 1. Primary Purpose: response rate 2. Secondary purpose: toxicity, progression-free survival, overall survival Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Doxorubicin/Genexol-PM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Dec 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older adult women
- Instrumentation measurable lesions with histologically confirmed advanced (recurrent or metastatic) breast cancer
- ECOG 0-2
- Advanced breast cancer in the past, patients who did not receive chemotherapy
- Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more than 6 months until the patient
- life expectancy more than 3 months
- Agree in writing before the party to participate in a clinical trial to patients
Who cannot join
- immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients
- Severe infections requiring antibiotic therapy
- Clinically significant heart disease
- Pregnant or lactating woman
- Uncontrolled symptoms in the central nervous system (CNS) metastases
- Patients diagnosed with malignant tumors of other organs
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon
Hee Kyung Ahn, +82-32-460-3229
About this study
To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer
- Primary Purpose: response rate
- Secondary purpose: toxicity, progression-free survival, overall survival
- Conditions
- Metastatic Breast Cancer
- Being tested
- Doxorubicin/Genexol-PM
- Keywords
- breast cancer, doxorubicin, genexol-PM, paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxorubicin/Genexol-PMDrug
| Study group | Role | What they receive |
|---|---|---|
| doxotubicin/Genexol-PM | Experimental | Not described Receives: Drug: Doxorubicin/Genexol-PM |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: one year
Secondary outcomes (1)
number of participants with adverse events
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Kyung Cho, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784120
- Sponsor's protocol ID
- 2011-GIRBA-2566
- Status last verified
- Feb 2016
- First submitted
- 30 Jan 2013
- Last updated
- 10 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01784120
- Acronym / sponsor ID
- 2011-GIRBA-2566
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, doxorubicin, genexol-PM, paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Feb 2013 (estimated)
- 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.
To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer
- Primary Purpose: response rate
- Secondary purpose: toxicity, progression-free survival, overall survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| doxotubicin/Genexol-PM | Experimental | Drug: Doxorubicin/Genexol-PM |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older adult women
- Instrumentation measurable lesions with histologically confirmed advanced (recurrent or metastatic) breast cancer
- ECOG 0-2
- Advanced breast cancer in the past, patients who did not receive chemotherapy
- Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more than 6 months until the patient
Key exclusion criteria (6 listed)
- immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients
- Severe infections requiring antibiotic therapy
- Clinically significant heart disease
- Pregnant or lactating woman
- Uncontrolled symptoms in the central nervous system (CNS) metastases
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 |
|---|---|---|
| Doxorubicin/Genexol-PM | Drug | doxotubicin/Genexol-PM |
Primary outcome
response rate
Time frame: one year
1 secondary outcome
number of participants with adverse events
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
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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.
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 Doxorubicin/Genexol-PM in people with Metastatic Breast Cancer, run by Gachon University Gil Medical Center at 1 site in South Korea.
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 7 inclusion and 6 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 10 Feb 2016. 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 South Korea. 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?
Contact Hee Kyung Ahn (+82-32-460-3229, hkahn@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: one 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 10 Feb 2016.