Breast CancerPhase 3TABEANCT01200212
A Randomized Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer
A Phase 3 study testing Taxane, Avastin and Taxane, Avastin, Xeloda in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent results of the AVADO study report a similar result for the combination of docetaxel and bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Taxane, Avastin and Taxane, Avastin, Xeloda
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Oct 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status 0-2
- Histological confirmed carcinoma of the breast with no over expression of HER2
- Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone
- Patients must have either measurable or non-measurable target lesions according to RECIST criteria (phase III). Complete staging work-up within 4 weeks prior to registration. All patients must have chest X-ray (PA and lateral), abdominal ultrasound or CT scan or MRI, and bone scan. In case of positive bone scan, bone X-ray is mandatory. Other tests may be per- formed as clinically indicated
- The following previous systemic treatment are eligible:
- (neo)adjuvant chemotherapy (except if capecitabine was included) However if (neo)adjuvant chemotherapy was anthracycline based, the maximum cumulative dose of prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin. If taxanes or capecitabine were part of (neo)adjuvant treatment, a treatment-free interval of > 6 months is requested
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- adjuvant endocrine therapy.
- palliative endocrine treatments
- treatment with bisphosphonates
- treatment with immunotherapies
- Patient has to be fully recovered from previous radiotherapy. At least one measurable lesion must be completely outside the radiation field or there must be pathologic proof of progressive disease
- Absolute neutrophil count ≥ 2000 cells/ul, platelet count ≥ 100,000 cells/ul.
- Bilirubin ≤ 1.5x 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 ≤ 1,25x ULN or creatinin-clearance > 50 ml/min (according to Cockroft Gault). Urine dipstick for proteinuria <2+. Patients discovered to have ≥2+ proteinuria on dipstick urinalysis should undergo a 24 hour urine collection and must demonstrate ≤1 g of protein in 24 hours
- Negative pregnancy test (urine or serum) within 14 days prior to registration for all women of childbearing potential
- Patients must be available and compliant for treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating or a cooperating site
Who cannot join
- Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency
- Previous chemotherapy for metastatic disease, concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued
- Life expectancy of less than 3 months
- Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection).
- Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension (i.e. BP >150/100 mmHg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease-
- Currently active infection
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- Active peptic ulcer, incomplete wound healing or unhealed bone fracture
- Previous thromboembolic events, known hemorrhagic diathesis, coagulopathy with increased bleeding risk, or treatment with anticoagulants Current or recent (within 10 days of first dose of bevacizumab) use of acetylic acid (>325mg/day) or clopidogrel (> 75mg/day)
- Disease significantly affecting gastrointestinal function, e.g. mal- absorption syndrome, resection of the stomach or small bowel, ulcerative colitis; abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
- Major surgery within the last 28 days or anticipation of the need for major surgery during study treatment with bevacizumab. No minor surgeries including insertion of an indwelling catheter within 24 h prior to randomization
- Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and discontinuation of all steroids
- History of other malignancy within the last 5 years which could affect the diagnosis or assessment or outcome of metastatic breast cancer
- Concurrent treatment with other experimental drugs; participation in another clinical trial with any investigational drug within 30 days prior to study entry
- Treatment with sorivudine or derivates e.g. brivudine
- Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intra uterine contraceptive devices, sterilization) during study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase III Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer
The purpose of this study is to determine whether
- Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent results of the AVADO study report a similar result for the combination of docetaxel and bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of bevacizumab.
- As in metastatic breast cancer (MBC) poly-chemotherapies are frequently used, regimens with bevacizumab and at least 2 cytotoxic agents should be investigated.
- Docetaxel and capecitabine showed a benefit in PFS and survival. This combi- nation is therefore a reasonable choice.
- Dose of capecitabine and docetaxel should be reduced to 1800 mg/m2 and 75 mg/m2 to improve tolerability without compromising efficacy.
- Paclitaxel and capecitabine is well tolerated and showed a PFS of 10.3 months.
- Docetaxel 100 mg/m2 as monotherapy in MBC not very often used b/o toxicity. 75 mg/m2 much more accepted in daily practice. Better comparability with DBX, if both arms have 75mg/m2 docetaxel as assumed.
Read the detailed description
Primary Objective:
- To determine the Progression Free Survival (PFS) in patients with metastatic breast cancer after treatment with taxane plus bevacizumab with (TXB) or without capecitabine (TB).
Secondary Objective(s):
- To determine the objective response rate in both arms.
- To determine the duration of response in both arms.
- To determine the Time to Progression (TTP) in both arms.
- To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks in both arms.
- To determine the overall survival rate 3 years after "Last Patient In".
- To determine PFS and TTP response rates in patient's ≥ age 65.
- To determine the toxicity and compliance in both arms.
- To determine the predictive value of serum markers such as VEGF.
- Conditions
- Breast Cancer
- Being tested
- Taxane, Avastin, Taxane, Avastin, Xeloda
- Keywords
- Palliative Therapy, bevacizimab, Avastin, Xeloda, metastatic breast cancer, Progression Free Survival, Time to Progression, Overall survival
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxane, AvastinDrug
Taxane (Investigator can choose between Paclitaxel (80 mg/m2 weekly or Docetaxel 75 mg/m2 day 1 q 22) + Bevacizumab (15mg/kg) i.v. day 1 q 22 Given until progression, unacceptable toxicity, patient's request or withdrawal from study
Taxane, Avastin, XelodaDrug
Taxane (Investigator can choose between Paclitaxel (80 mg/m2 weekly or Docetaxel 75 mg/m2 day 1 q 22) + Bevacizumab (15mg/kg) i.v. day 1 q 22 + Capecitabine 1800 mg/m2 day 1-14 q22 Given until progression, unacceptable toxicity, patient's request or withdrawal from study
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | A Taxane (80mg/m2 Paclitaxel weekly or 75mg/m2 Docetaxel day1 q22) + 15mg/kg Bevacizumab day1 q22 + 1800 mg/m2 Capecitabine day 1-14 q22 Receives: Drug: Taxane, Avastin, Xeloda |
| B | Active comparator | A Taxane (80mg/m2 Paclitaxel weekly or 75mg/m2 Docetaxel day1 q22) + 15mg/kg Bevacizumab day1 q22 Receives: Drug: Taxane, Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log"
Measured: 10 month
Secondary outcomes (8)
To determine the objective response rate in both arms
Measured: End of Study
To determine the duration of response in both arms.
Measured: End of Study
To determine the Time to Progression (TTP) in both arms.
Measured: End of Study
To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks in both arms.
Measured: End of Study
To determine the overall survival rate 3 years after "Last Patient In".
Measured: End of Study
To determine PFS and TTP response rates in patient's ≥ age 65.
Measured: End of Study
To determine the toxicity and compliance in both arms.
Measured: End of Study
To determine the predictive value of serum markers such as VEGF
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startJul 2009
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: A planed interim analysis shows no benefits, but higher adverse event rates for the experimental arm.
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
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GBG Forschungs GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans-Joachim Lück, Prof. Dr., Principal investigator, GBG Forschungs GmbHKristina Lübbe, Dr., Study chair, GBG Forschungs GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200212
- Sponsor's protocol ID
- GBG 43
- Other IDs
- 2008-003997-17, 2008
- Acronym
- TABEA
- Status last verified
- May 2013
- First submitted
- 10 Sep 2010
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01200212
- Acronym / sponsor ID
- TABEA / GBG 43
- Conditions
- Breast Cancer
- Keywords
- Palliative Therapy, bevacizimab, Avastin, Xeloda, metastatic breast cancer, Progression Free Survival, Time to Progression, Overall survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A planed interim analysis shows no benefits, but higher adverse event rates for the experimental arm.
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- GBG Forschungs GmbHUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Sep 2010 (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 purpose of this study is to determine whether
- Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent results of the AVADO study report a similar result for the combination of docetaxel and bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of bevacizumab.
- As in metastatic breast cancer (MBC) poly-chemotherapies are frequently used, regimens with bevacizumab and at least 2 cytotoxic agents should be investigated.
- Docetaxel and capecitabine showed a benefit in PFS and survival. This combi- nation is therefore a reasonable choice.
- Dose of capecitabine and docetaxel should be reduced to 1800 mg/m2 and 75 mg/m2 to improve tolerability without compromising efficacy.
- Paclitaxel and capecitabine is well tolerated and showed a PFS of 10.3 months.
- Docetaxel 100 mg/m2 as monotherapy in MBC not very often used b/o toxicity. 75 mg/m2 much more accepted in daily practice. Better comparability with DBX, if both arms have 75mg/m2 docetaxel as assumed.
Detailed description
Primary Objective:
- To determine the Progression Free Survival (PFS) in patients with metastatic breast cancer after treatment with taxane plus bevacizumab with (TXB) or without capecitabine (TB).
Secondary Objective(s):
- To determine the objective response rate in both arms.
- To determine the duration of response in both arms.
- To determine the Time to Progression (TTP) in both arms.
- To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks in both arms.
- To determine the overall survival rate 3 years after "Last Patient In".
- To determine PFS and TTP response rates in patient's ≥ age 65.
- To determine the toxicity and compliance in both arms.
- To determine the predictive value of serum markers such as VEGF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Taxane, Avastin, XelodaA Taxane (80mg/m2 Paclitaxel weekly or 75mg/m2 Docetaxel day1 q22) + 15mg/kg Bevacizumab day1 q22 + 1800 mg/m2 Capecitabine day 1-14 q22 |
| B | Active comparator | Drug: Taxane, AvastinA Taxane (80mg/m2 Paclitaxel weekly or 75mg/m2 Docetaxel day1 q22) + 15mg/kg Bevacizumab day1 q22 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- ECOG performance status 0-2
- Histological confirmed carcinoma of the breast with no over expression of HER2
- Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone
- Patients must have either measurable or non-measurable target lesions according to RECIST criteria (phase III). Complete staging work-up within 4 weeks prior to registration. All patients must have chest X-ray (PA and lateral), abdominal ultrasound or CT scan or MRI, and bone scan. In case of positive bone scan, bone X-ray is mandatory. Other tests may be per- formed as clinically indicated
- The following previous systemic treatment are eligible:
Key exclusion criteria (15 listed)
- Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency
- Previous chemotherapy for metastatic disease, concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued
- Life expectancy of less than 3 months
- Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection).
- Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension (i.e. BP >150/100 mmHg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease-
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 |
|---|---|---|
| Taxane, AvastinTaxane (Investigator can choose between Paclitaxel (80 mg/m2 weekly or Docetaxel 75 mg/m2 day 1 q 22) + Bevacizumab (15mg/kg) i.v. day 1 q 22 Given until progression, unacceptable toxicity, patient's request or withdrawal from study | Drug | B |
| Taxane, Avastin, XelodaTaxane (Investigator can choose between Paclitaxel (80 mg/m2 weekly or Docetaxel 75 mg/m2 day 1 q 22) + Bevacizumab (15mg/kg) i.v. day 1 q 22 + Capecitabine 1800 mg/m2 day 1-14 q22 Given until progression, unacceptable toxicity, patient's request or withdrawal from study | Drug | A |
Primary outcome
Progression free survival (PFS)
Time frame: 10 month
The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log"
8 secondary outcomes
To determine the objective response rate in both arms
Time frame: End of Study
To determine the duration of response in both arms.
Time frame: End of Study
To determine the Time to Progression (TTP) in both arms.
Time frame: End of Study
To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks in both arms.
Time frame: End of Study
To determine the overall survival rate 3 years after "Last Patient In".
Time frame: End of Study
To determine PFS and TTP response rates in patient's ≥ age 65.
Time frame: End of Study
To determine the toxicity and compliance in both arms.
Time frame: End of Study
To determine the predictive value of serum markers such as VEGF
Time frame: End of Study
Results and safety
The study was stopped early (reason given: A planed interim analysis shows no benefits, but higher adverse event rates for the experimental arm.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
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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.
Hans-Joachim Lück, Prof. Dr. principal investigator
GBG Forschungs GmbH
Kristina Lübbe, Dr. study chair
GBG 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 Taxane, Avastin and Taxane, Avastin, Xeloda 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 16 inclusion and 15 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: stopped early, as of the sponsor's last update on 22 May 2013. 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 was stopped early (reason given: A planed interim analysis shows no benefits, but higher adverse event rates for the experimental arm.). Results are not available in the source record.
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?
Progression free survival (PFS) (time frame: 10 month). 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 22 May 2013; AzTrials last refreshed its copy on 6 Nov 2026.