Stage IIIB, IV, Recurrent, and Metastatic Breast CancerNCT02188693
Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer
An observational study of Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer and Gemcitabine, run by Xijing Hospital at 1 site in China.
Trial summary
The primary purpose of our study is to evaluate whether gemcitabine as a single agent is superior to observation in improving progression-free survival (PFS) in patients with metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG as their first-line treatment Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer, Gemcitabine, Maintenance Chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 267 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2017
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
Study population: Patients with MBC exhibited disease control (complete response + partial response + stable disease) with first-line PG and were randomly assigned to maintenance chemotherapy or observation.
Who may be able to join
- Histologically Confirmed Metastatic, or Recurrent Breast Cancer
- Age over 18 Years
- ECOG Performance Status 0-2
- Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
- Life Expectancy ≥ 3 Months
- Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
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- Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
- Prior Hormonal Therapy as a Treatment of Metastatic Disease is Allowed. But Antitumoral Hormonal Therapy Must be Terminated Prior to Enrollment(up to the Date of Randomization)
- Prior Radiation Therapy Allowed as Long as < 25% of the Bone Marrow Has Been Treated,and the Patients Must Have Recovered From the Acute Toxic Effects of the Treatment Prior to Study Enrollment.Prior Radiation to the Whole Pelvis is Not Allowed. Prior Radiotherapy Must be Completed 4 Weeks Before Study Entry.
- Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)
- Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
- No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
- Written Informed consent
Who cannot join
- Serious Uncontrolled Intercurrent Infections
- Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
- Pregnancy or Breast Feeding
- Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
- Documented Parenchymal or Leptomeningeal Brain Metastasis
- Peripheral Neuropathy ≥ Grade 2
- Prior Treatment With Gemcitabine Will Not be Allowed.
- HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital ， Fourth Military Medical University
Xi'an, Shaanxi, 710032
Li Nanlin, Ph.D, +86-137-0911-3279, nanlin-74@163.com
Chen Cong, Master, +86-136-4929-4730, congcongfeiyang@126.com
About this study
Official title: Maintenance Versus Observation With 6 Cycles of Gemcitabine Plus Taxol Sequential Gemcitabine Single Agent in Patients With Metastatic Breast Cancer
The primary purpose of our study is to evaluate whether gemcitabine as a single agent is superior to observation in improving progression-free survival (PFS) in patients with metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG as their first-line treatment
- Conditions
- Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer, Gemcitabine, Maintenance Chemotherapy
- Medical subject headings
- Recurrence, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Experimental | Gemcitabine 1250 mg/m2, IV on day 1 of 21 day cycle,with a follow up for every 12 weeks until disease progression or the date of first documented death from any cause | |
| Observational | Observation for every 12 weeks until disease progression or the date of first documented death from any cause |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Measured: From randomization to disease progression
PFS(progression free survival)
Measured: time from the date of randomization until the date of disease progression，assessed up to 3 years
PFS(progression free survival)
PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death,assessed up to 3 years
Measured: the time from the date of randomization until the date of disease progression,assessed up to 3 years
Secondary outcomes (1)
OS(overall survival)
the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years
Measured: the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIB, IV, Recurrent, and Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 267 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital
- Investigators
- Li Nanlin, Ph.D, Study director, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188693
- Sponsor's protocol ID
- NLLY-01
- Status last verified
- Jul 2014
- First submitted
- 9 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Versus Observation With 6 Cycles of Gemcitabine Plus Taxol Sequential Gemcitabine Single Agent in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02188693
- Acronym / sponsor ID
- NLLY-01
- Conditions
- Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer, Gemcitabine, Maintenance Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Jul 2014 (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.
The primary purpose of our study is to evaluate whether gemcitabine as a single agent is superior to observation in improving progression-free survival (PFS) in patients with metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG as their first-line treatment
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Experimental | – | –Gemcitabine 1250 mg/m2, IV on day 1 of 21 day cycle,with a follow up for every 12 weeks until disease progression or the date of first documented death from any cause |
| Observational | – | –Observation for every 12 weeks until disease progression or the date of first documented death from any cause |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MBC exhibited disease control (complete response + partial response + stable disease) with first-line PG and were randomly assigned to maintenance chemotherapy or observation.
Key inclusion criteria (14 listed)
- Histologically Confirmed Metastatic, or Recurrent Breast Cancer
- Age over 18 Years
- ECOG Performance Status 0-2
- Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
- Life Expectancy ≥ 3 Months
Key exclusion criteria (8 listed)
- Serious Uncontrolled Intercurrent Infections
- Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
- Pregnancy or Breast Feeding
- Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
- Documented Parenchymal or Leptomeningeal Brain Metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS
Time frame: From randomization to disease progression
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
PFS(progression free survival)
Time frame: time from the date of randomization until the date of disease progression，assessed up to 3 years
PFS(progression free survival)
Time frame: the time from the date of randomization until the date of disease progression,assessed up to 3 years
PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death,assessed up to 3 years
1 secondary outcome
OS(overall survival)
Time frame: the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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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.
Li Nanlin, Ph.D study director
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer and Gemcitabine, run by Xijing Hospital 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 14 inclusion and 8 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 14 Jul 2014. 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.
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 Li Nanlin, Ph.D (+86-137-0911-3279, nanlin-74@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From randomization to disease progression). The study lists 3 primary outcomes in all. 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 14 Jul 2014.