Metastatic Breast CancerPhase 1RiTaNCT00661739
A Multicentre Phase I-II Study to Investigate the Combination of Bendamustine With Weekly Paclitaxel as First or Second Line Therapy in Patients With Metastatic Breast Cancer
A Phase 1 study testing Bendamustine in people with Metastatic Breast Cancer, run by GBG Forschungs GmbH.
Trial summary
The aim of the study is to establish a feasible combination of bendamustine and paclitaxel in a weekly schedule. The two agents have different toxicity profiles and are well tolerated when given in a weekly fashion. The combination might be of special interest for elderly patients with hormone insensitive 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?
- Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to May 2011
- Phase
- Phase 1
- 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 must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
- Pathological confirmed primary carcinoma of the breast.
- Locally advanced or metastatic disease
- Up to one previous palliative chemotherapy that did not contain docetaxel or paclitaxel. Previous adjuvant treatment with taxanes is allowed when the last application of the taxane was given at least 1 year before entering the trial.
- Patients must have either measurable or non-measurable lesions according to the WHO criteria
- At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease.
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- Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated
- Karnofsky-Index ≥ 60 %
- Age ≥ 18 years
- Absolute neutrophil count ≥ 1,500 cells/µl, platelets ≥ 100,000/µl, and hemoglobin ≥ 9 g/dl
- Bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase ≤ 5x upper normal limit
- Serum creatinine ≤ 2.0 mg/dl
- Normal left ventricular ejection fraction (LVEF) by echocardiogramme
- Patients of childbearing potential, pregnancy test must be negative
- If fertile effective contraception must be used throughout the study
Who cannot join
- Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances;
- Concurrent immunotherapy or hormonal treatment for cancer (Bisphosphonates may be continued)
- Symptomatic parenchymal brain metastases not responding to treatment
- Life expectancy less than 3 months
- Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
- Concurrent treatment with other experimental drugs or any other anti-cancer therapy within the last 28 days;
- History of congestive heart failure or other significant uncontrolled cardiac disease
- Pregnant or nursing women
About this study
The aim of the study is to establish a feasible combination of bendamustine and paclitaxel in a weekly schedule. The two agents have different toxicity profiles and are well tolerated when given in a weekly fashion. The combination might be of special interest for elderly patients with hormone insensitive breast cancer
- Conditions
- Metastatic Breast Cancer
- Being tested
- Bendamustine
- Keywords
- palliative, Breast cancer, metastatic, Bendamustine, phase I
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Ribomustine
Dose-level Bendamustine(mg/m²): I:50; II:60; III:60; IV:70; V:70 Dose-level Paclitaxel (mg/m²): I:60; II:60; III:80; IV:80; V:90 Treatment will be given on day 1,8,15 and repeated on day 29. When the recommended dose has been determined a total of 48 pts will be treated at this dose level.
| Study group | Role | What they receive |
|---|---|---|
| Singular Arm | Experimental | Bendamustine treatment Receives: Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel.
Measured: end of cycle 2 of the 6th patient of the assumed highest dose level
Secondary outcomes (1)
To determine the objective response rate (phase II part)
Measured: EOT last patient (phase II part)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startJul 2005
- Primary completionSep 2010
- Study completionMay 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- GBG Forschungs GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661739
- Sponsor's protocol ID
- GBG 38
- Acronym
- RiTa
- Status last verified
- Sep 2010
- First submitted
- 15 Apr 2008
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Phase I-II Study to Investigate the Combination of Bendamustine With Weekly Paclitaxel as First or Second Line Therapy in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00661739
- Acronym / sponsor ID
- RiTa / GBG 38
- Conditions
- Metastatic Breast Cancer
- Keywords
- palliative, Breast cancer, metastatic, Bendamustine, phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- GBG Forschungs GmbHUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Apr 2008 (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 aim of the study is to establish a feasible combination of bendamustine and paclitaxel in a weekly schedule. The two agents have different toxicity profiles and are well tolerated when given in a weekly fashion. The combination might be of special interest for elderly patients with hormone insensitive breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Singular Arm | Experimental | Drug: BendamustineBendamustine treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
- Pathological confirmed primary carcinoma of the breast.
- Locally advanced or metastatic disease
- Up to one previous palliative chemotherapy that did not contain docetaxel or paclitaxel. Previous adjuvant treatment with taxanes is allowed when the last application of the taxane was given at least 1 year before entering the trial.
- Patients must have either measurable or non-measurable lesions according to the WHO criteria
Key exclusion criteria (8 listed)
- Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances;
- Concurrent immunotherapy or hormonal treatment for cancer (Bisphosphonates may be continued)
- Symptomatic parenchymal brain metastases not responding to treatment
- Life expectancy less than 3 months
- Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
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 |
|---|---|---|
| BendamustineAlso: RibomustineDose-level Bendamustine(mg/m²): I:50; II:60; III:60; IV:70; V:70 Dose-level Paclitaxel (mg/m²): I:60; II:60; III:80; IV:80; V:90 Treatment will be given on day 1,8,15 and repeated on day 29. When the recommended dose has been determined a total of 48 pts will be treated at this dose level. | Drug | Singular Arm |
Primary outcome
The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel.
Time frame: end of cycle 2 of the 6th patient of the assumed highest dose level
1 secondary outcome
To determine the objective response rate (phase II part)
Time frame: EOT last patient (phase II part)
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 2 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bendamustine in people with Metastatic Breast Cancer, run by GBG Forschungs GmbH.
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 15 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: finished, as of the sponsor's last update on 2 Sep 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel. (time frame: end of cycle 2 of the 6th patient of the assumed highest dose level). 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 2 Sep 2011.