Breast CancerPhase 3NCT00148876
TBP Study With Capecitabine Plus Minus Trastuzumab
A Phase 3 study testing Capecitabine and Trastuzumab in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.
Trial summary
This study is done in patients having Breast Cancer with metastasis (patients with positive receptor HER2) whose disease progressed after receiving Trastuzumab. The primary objective of this study is to compare the time until disease progression between the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Capecitabine and Trastuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2003to Jan 2011
- Phase
- Phase 3
- 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
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
- Pathologically confirmed carcinoma of the breast.
- Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
- HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (DAKO) 3+ or gene namplification detected by FISH. HER2-positive primary tumours with HER2-negative metastasis can be included.
- Disease progression during or after previous chemotherapy and trastuzumab treatment as follows (Trastuzumab has to be given previously for at least 12 weeks, treatment free interval of trastuzumab for a maximum of 6 weeks):
- Taxanes + trastuzumab given as adjuvant therapy
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- Taxanes + trastuzumab given as first line therapy for palliation
- Trastuzumab given as first line therapy for palliation alone or in combination with chemotherapeutic agents other than capecitabine or taxanes
- No more than 1 chemotherapy for palliation (max. Adriamycin dose < or = 400 mg/m²; Epirubicin < or = 600 mg/m²)
- Patients must have either measurable or nonmeasurable target lesions according to the RECIST criteria (see Appendix 6)
- At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease
- At least 4 weeks since major surgery with full recovery.
- Complete radiology and tumor measurement work up within 4 weeks prior to registration:
- Karnofsky performance status evaluation > or = 60%
- Age >18 years.
- Absolute neutrophil count > or =1,500 cells/microL, platelet count > or =100,000 cells/microL.
- Bilirubin < or = 2x the upper limit of normal for the institution (ULN); elevation of transaminases and alkaline phosphatase < 2.5x ULN or <5x ULN for patients with liver metastases.
- Creatinine < or = 2.0 mg/dl.
- Left ventricular ejection fraction (LVEF) by cardiac ultrasound of > or = 50%.
- If of childbearing potential, pregnancy test is negative. In addition the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
Who cannot join
- Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
- Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and of all steroids.
- Life expectancy of less than 3 months.
- Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including severe pulmonary conditions, AIDS and serious active infection).
- History of congestive heart failure or other significant uncontrolled cardiac disease.
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- History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
- Treatment with sorivudine or derivates e.g. brivudin
- Pregnant or nursing women.
- Male patients.
- The patient must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre which could be the Principal or Co- investigator's site.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johann Wolfgang Goethe Universität, Universitätsfrauenklinik
Frankfurt am Main, Hesse, 60590
About this study
Official title: A Multicenter Randomized Phase III Study to Compare Capecitabine Alone or in Combination With Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer and Progression After Previous Treatment With Trastuzumab
This study is done in patients having Breast Cancer with metastasis (patients with positive receptor HER2) whose disease progressed after receiving Trastuzumab.
The primary objective of this study is to compare the time until disease progression between the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE + TRASTUZUMAB
The study has also other secondary and tertiary objectives.
Read the detailed description
Trial design:
Prospective, multi-center, controlled, non blinded, randomized phase III Study
Treatment:
Patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab are being randomized to either:
- Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression * and discontinuation of Trastuzumab
- Capecitabine and Trastuzumab:
Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression * Trastuzumab 6 mg/kg body weight every 3 weeks i.v. as a 90 min infusion until progression *
Objectives:
Primary objective:
To compare the time to disease progression in patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab randomized to capecitabine alone or in combination with trastuzumab.
Secondary objectives:
To compare the objective response rate between the two arms To compare the duration of response To compare the clinical benefit defined as CR, PR, or stable disease > 24 weeks between the two arms To evaluate the safety of the capecitabine + trastuzumab combination To compare overall survival between the two arms
Tertiary objective:
To determine the HER2 status in tissue collected directly before study entry
- Conditions
- Breast Cancer
- Being tested
- Capecitabine, Trastuzumab
- Keywords
- Progression after treatment with Trastuzumab, Metastatic Breast Cancer, Palliative Study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Capecitabine 2500 mg/m² orally day 1-14 q day 22
TrastuzumabDrug
Trastuzumab 6 mg/kg body weight every 3 weeks i.v.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Active comparator | Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression and discontinuation of Trastuzumab. Receives: Drug: Capecitabine |
| Capecitabine and Trastuzumab | Experimental | Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression + Trastuzumab 6 mg/kg body weight every 3 weeks i.v. as a 90 min infusion until progression Receives: Drug: Capecitabine; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any progression of disease or disease related death of a patient
Secondary outcomes (5)
Any response documented according to the RECIST Criteria
Time from CR or PR until progression of disease or death due to any cause
Any response and stable disease of >24 weeks duration documented according to the RECIST Criteria
Any grade III/IV toxicity (NCI-CTC version2.0).Premature treatment discontinuation
Any death of a patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GBG Forschungs GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Gunter von Minckwitz, Prof. Dr., Principal investigator, German Breast Group Forschungs GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148876
- Sponsor's protocol ID
- GBG 26
- Other IDs
- BIG3-05
- Status last verified
- Feb 2011
- First submitted
- 7 Sep 2005
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase III Study to Compare Capecitabine Alone or in Combination With Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer and Progression After Previous Treatment With Trastuzumab
- ClinicalTrials.gov ID
- NCT00148876
- Acronym / sponsor ID
- GBG 26
- Conditions
- Breast Cancer
- Keywords
- Progression after treatment with Trastuzumab, Metastatic Breast Cancer, Palliative Study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- GBG Forschungs GmbHUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Sep 2003
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Sep 2005 (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.
This study is done in patients having Breast Cancer with metastasis (patients with positive receptor HER2) whose disease progressed after receiving Trastuzumab.
The primary objective of this study is to compare the time until disease progression between the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE + TRASTUZUMAB
The study has also other secondary and tertiary objectives.
Detailed description
Trial design:
Prospective, multi-center, controlled, non blinded, randomized phase III Study
Treatment:
Patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab are being randomized to either:
- Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression * and discontinuation of Trastuzumab
- Capecitabine and Trastuzumab:
Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression * Trastuzumab 6 mg/kg body weight every 3 weeks i.v. as a 90 min infusion until progression *
Objectives:
Primary objective:
To compare the time to disease progression in patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab randomized to capecitabine alone or in combination with trastuzumab.
Secondary objectives:
To compare the objective response rate between the two arms To compare the duration of response To compare the clinical benefit defined as CR, PR, or stable disease > 24 weeks between the two arms To evaluate the safety of the capecitabine + trastuzumab combination To compare overall survival between the two arms
Tertiary objective:
To determine the HER2 status in tissue collected directly before study entry
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Active comparator | Drug: CapecitabineCapecitabine 2500 mg/m² orally day 1-14 q day 22 until progression and discontinuation of Trastuzumab. |
| Capecitabine and Trastuzumab | Experimental | Drug: Capecitabine, Drug: TrastuzumabCapecitabine 2500 mg/m² orally day 1-14 q day 22 until progression + Trastuzumab 6 mg/kg body weight every 3 weeks i.v. as a 90 min infusion until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
- Pathologically confirmed carcinoma of the breast.
- Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
- HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (DAKO) 3+ or gene namplification detected by FISH. HER2-positive primary tumours with HER2-negative metastasis can be included.
- Disease progression during or after previous chemotherapy and trastuzumab treatment as follows (Trastuzumab has to be given previously for at least 12 weeks, treatment free interval of trastuzumab for a maximum of 6 weeks):
Key exclusion criteria (12 listed)
- Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
- Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and of all steroids.
- Life expectancy of less than 3 months.
- Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including severe pulmonary conditions, AIDS and serious active infection).
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 |
|---|---|---|
| CapecitabineCapecitabine 2500 mg/m² orally day 1-14 q day 22 | Drug | Capecitabine, Capecitabine and Trastuzumab |
| TrastuzumabTrastuzumab 6 mg/kg body weight every 3 weeks i.v. | Drug | Capecitabine and Trastuzumab |
Primary outcome
Any progression of disease or disease related death of a patient
5 secondary outcomes
Any response documented according to the RECIST Criteria
Time from CR or PR until progression of disease or death due to any cause
Any response and stable disease of >24 weeks duration documented according to the RECIST Criteria
Any grade III/IV toxicity (NCI-CTC version2.0).Premature treatment discontinuation
Any death of a patient
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 23 Feb 2011.
- Click here for more information about this study: TBP StudyLink provided by the sponsor.
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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.
Gunter von Minckwitz, Prof. Dr. principal investigator
German Breast Group Forschungs GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine and Trastuzumab in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.
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 20 inclusion and 12 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 23 Feb 2011. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Any progression of disease or disease related death of a patient. 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 23 Feb 2011.