Metastatic Breast CancerPhase 2NCT00480597
Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer
A Phase 2 study testing gemcitabine, cisplatin and vinorelbine in people with Metastatic Breast Cancer, run by Ludwig-Maximilians - University of Munich.
Trial summary
Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings. For each randomisation arm, 47 patients will be included. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- gemcitabine, cisplatin and vinorelbine
- How many people
- 141 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to not given
- 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
- Histologically confirmed metastatic breast cancer
- All patients were required to give written informed consent
- Only one prior chemotherapy for metastatic breast cancer was allowed. This clinical trial was designed to test the efficacy of a second-line chemotherapy.
- Antracycline-pretreatment during aduvant or palliative first line therapy
- Bidimensionally measurable lesion outside a previous radiation field.
- Age >= 18 years
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- Karnofsky Performance status >= 70%
- Adequate heamatological, renal, cardiac and hepatic function
- No radiation of the measurable lesion during the study was allowed.
Who cannot join
- Only bone metastases
- Active infection
- Previous treatment with one of the study drugs
- Application of other cytotoxic chemotherapy
- Insufficent renal function (creatinine clearance < 60ml/min)
- Known DPD deficiency
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- clinically unstable brain metastasis
- pregancy or lactation
- other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin).
About this study
Official title: Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine
Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.
For each randomisation arm, 47 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.
Study Design:
Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks
Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks
Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks
- Conditions
- Metastatic Breast Cancer
- Being tested
- gemcitabine, cisplatin, vinorelbine, capecitabine
- Keywords
- gemcitabine, vinorelbine, cisplatin, capecitabine, pretreated metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
cisplatinDrug
vinorelbineDrug
capecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: one year after last patient in
Secondary outcomes (3)
Time to progression
Measured: one year after last patient in
Overall Survival
Measured: one year after last patient in
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Volker Heinemann, PhD, MD, Principal investigator, University of Munich - Klinikum Grosshadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480597
- Sponsor's protocol ID
- Gemcitabin 02 MC
- Status last verified
- May 2007
- First submitted
- 30 May 2007
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PubMed 34037241
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine
- ClinicalTrials.gov ID
- NCT00480597
- Acronym / sponsor ID
- Gemcitabin 02 MC
- Conditions
- Metastatic Breast Cancer
- Keywords
- gemcitabine, vinorelbine, cisplatin, capecitabine, pretreated metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Oct 2002
- First posted
- 31 May 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.
Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.
For each randomisation arm, 47 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.
Study Design:
Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks
Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks
Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed metastatic breast cancer
- All patients were required to give written informed consent
- Only one prior chemotherapy for metastatic breast cancer was allowed. This clinical trial was designed to test the efficacy of a second-line chemotherapy.
- Antracycline-pretreatment during aduvant or palliative first line therapy
- Bidimensionally measurable lesion outside a previous radiation field.
Key exclusion criteria (9 listed)
- Only bone metastases
- Active infection
- Previous treatment with one of the study drugs
- Application of other cytotoxic chemotherapy
- Insufficent renal function (creatinine clearance < 60ml/min)
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 | Drug | – |
| cisplatin | Drug | – |
| vinorelbine | Drug | – |
| capecitabine | Drug | – |
Primary outcome
Response rate
Time frame: one year after last patient in
3 secondary outcomes
Time to progression
Time frame: one year after last patient in
Overall Survival
Time frame: one year after last patient in
Toxicity
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 28 Oct 2010.
- Derived from this study: PubMed 34037241Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
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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.
Volker Heinemann, PhD, MD principal investigator
University of Munich - Klinikum Grosshadern
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine, cisplatin and vinorelbine in people with Metastatic Breast Cancer, run by Ludwig-Maximilians - University of Munich.
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 9 inclusion and 9 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 28 Oct 2010. 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?
Response rate (time frame: one year after last patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00480597, which also lists 1 linked publication.
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 28 Oct 2010.