Metastatic Breast CancerPhase 2NCT00532623
Phase II Study of Gemcitabine/Vinorelbine vs Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer
A Phase 2 study testing Gemcitabine plus Vinorelbine and Sequential in people with Metastatic Breast Cancer, run by National Cancer Center, Korea.
Trial summary
To evaluate the overall response rate of gemcitabine and vinorelbine combination (GV) and gemcitabine followed by vinorelbine (G⇒V) when used as palliative therapy in patients with stage IV and recurrent breast cancer. 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?
- Gemcitabine plus Vinorelbine and Sequential
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Oct 2006
- 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
- Histologic or cytologic diagnosis of stage IV or recurrent breast cancer.
- Previous anthracycline and/or taxane and/or capecitabine chemotherapy in adjuvant and metastatic setting.
- Previous hormonal therapy in adjuvant and metastatic setting.
- Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
- No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study.
- Performance status of 0, 1, 2 on the ECOG criteria.
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- Clinically measurable disease, defined as unidimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at least 1cm by 1cm, as defined by x-ray, CT scan, MRI,or physical examination.
- Estimated life expectancy of at least 12 weeks.
- Patient compliance that allow adequate follow-up.
- Adequate hematologic (WBC count3,000/mm3, platelet count100,000/mm3), hepatic (bilirubin level1.5 mg/dL, AST, ALT3xULN), and renal (creatinine concentration 1.5 mg/dL) function.
- Informed consent from patient or patient's relative.
- Females at least 18 years of age.
- Childbearing women should use non-hormonal contraceptive method.
Who cannot join
- Previous chemotherapy > 3 for recurrent or stage IV disease Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
About this study
Official title: A Phase II Study of Gemcitabine in Combination With Vinorelbine vs. Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer
To evaluate the overall response rate of gemcitabine and vinorelbine combination (GV) and gemcitabine followed by vinorelbine (G⇒V) when used as palliative therapy in patients with stage IV and recurrent breast cancer.
Read the detailed description
This is an open-label, randomized, two-arm, parallel group phase II study. Eligible patients will be randomized to each of the two treatment regimens, one of which is gemcitabine and vinorelbine combination therapy (Group A) and the other is gemcitabine monotherapy followed by vinorelbine monotherapy (Group B). Patients In group A monotherapy will receive gemcitabine and vinorelbine in combination, while patients in group B will receive gemcitabine monotherapy until the evidence of disease progression followed by vinorelbine. A total of 82 patients will be enrolled in this study. Patients will be randomized after stratified according to the number of prior chemotherapy including adjuvant chemotherapy and visceral disease. No maximum number of cycles is pre-determined. Patients may continue on study therapy until documented treatment failure.
Patients in group A who discontinue study therapy will proceed to the post-therapy follow-up phase of the study. Patients in group B who discontinue study therapy while treated with gemcitabine will proceed to receive vinorelbine on disease progression. Patients on vinorelbine who discontinue study therapy will proceed to the post-therapy follow-up phase of the study. Further treatment upon discontinuation of study therapy is at the discretion of the investigator.
A two arm, open label phase II study without control is appropriate for exploring the efficacy of gemcitabine with concurrent or sequential vinorelbine in this patient population and for evaluating and characterizing toxicities of two treatment approaches, qualitatively and quantitatively. The purpose of randomization in this phase II study is to diminish the possible impact of selection bias on treatment outcome and thus on interpretation of efficacy and safety data.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Gemcitabine plus Vinorelbine, Sequential
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine plus VinorelbineDrug
Also called Gemzar, Navelbine
Gemcitabine, 1,000mg/m2 and Vinorelbine, 25mg/m2, on day 1 and day 8, every 3 week cycles
SequentialDrug
Also called Gemzar, Navelbine
Gemcitabine monotherapy followed by Vinorelbine monotherapy:
-Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles.
| Study group | Role | What they receive |
|---|---|---|
| Combination | Active comparator | Not described Receives: Drug: Gemcitabine plus Vinorelbine |
| Seqeuntial | Active comparator | Gemcitabine monotherapy followed by Vinorelbine monotherapy:
-Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles. Receives: Drug: Sequential |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startMay 2004
- Primary completionSep 2006
- Study completionOct 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Jungsil Ro, MD, PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532623
- Sponsor's protocol ID
- NCCCTS-04-092
- Status last verified
- Sep 2007
- First submitted
- 19 Sep 2007
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemcitabine in Combination With Vinorelbine vs. Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00532623
- Acronym / sponsor ID
- NCCCTS-04-092
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- May 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 20 Sep 2007 (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 the overall response rate of gemcitabine and vinorelbine combination (GV) and gemcitabine followed by vinorelbine (G⇒V) when used as palliative therapy in patients with stage IV and recurrent breast cancer.
Detailed description
This is an open-label, randomized, two-arm, parallel group phase II study. Eligible patients will be randomized to each of the two treatment regimens, one of which is gemcitabine and vinorelbine combination therapy (Group A) and the other is gemcitabine monotherapy followed by vinorelbine monotherapy (Group B). Patients In group A monotherapy will receive gemcitabine and vinorelbine in combination, while patients in group B will receive gemcitabine monotherapy until the evidence of disease progression followed by vinorelbine. A total of 82 patients will be enrolled in this study. Patients will be randomized after stratified according to the number of prior chemotherapy including adjuvant chemotherapy and visceral disease. No maximum number of cycles is pre-determined. Patients may continue on study therapy until documented treatment failure.
Patients in group A who discontinue study therapy will proceed to the post-therapy follow-up phase of the study. Patients in group B who discontinue study therapy while treated with gemcitabine will proceed to receive vinorelbine on disease progression. Patients on vinorelbine who discontinue study therapy will proceed to the post-therapy follow-up phase of the study. Further treatment upon discontinuation of study therapy is at the discretion of the investigator.
A two arm, open label phase II study without control is appropriate for exploring the efficacy of gemcitabine with concurrent or sequential vinorelbine in this patient population and for evaluating and characterizing toxicities of two treatment approaches, qualitatively and quantitatively. The purpose of randomization in this phase II study is to diminish the possible impact of selection bias on treatment outcome and thus on interpretation of efficacy and safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination | Active comparator | Drug: Gemcitabine plus Vinorelbine |
| Seqeuntial | Active comparator | Drug: SequentialGemcitabine monotherapy followed by Vinorelbine monotherapy: -Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologic or cytologic diagnosis of stage IV or recurrent breast cancer.
- Previous anthracycline and/or taxane and/or capecitabine chemotherapy in adjuvant and metastatic setting.
- Previous hormonal therapy in adjuvant and metastatic setting.
- Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
- No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study.
Key exclusion criteria (2 listed)
- Previous chemotherapy > 3 for recurrent or stage IV disease Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
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 |
|---|---|---|
| Gemcitabine plus VinorelbineAlso: Gemzar, NavelbineGemcitabine, 1,000mg/m2 and Vinorelbine, 25mg/m2, on day 1 and day 8, every 3 week cycles | Drug | Combination |
| SequentialAlso: Gemzar, NavelbineGemcitabine monotherapy followed by Vinorelbine monotherapy: -Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles. | Drug | Seqeuntial |
Primary outcome
overall response rate
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
Jungsil Ro, MD, PhD principal investigator
National Cancer Center, Korea
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine plus Vinorelbine and Sequential in people with Metastatic Breast Cancer, run by National Cancer Center, 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 13 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
overall response rate (time frame: 3 years). 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 27 Jun 2011.