Brain MetastasesPhase 2NCT00538343
RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases
A Phase 2 study testing berubicin hydrochloride (RTA 744) in people with Brain Metastases, run by Biogen at 7 sites in United States.
Trial summary
The purpose of this study is to determine whether RTA 744 is effective in the treatment of breast cancer that has metastasized to the brain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Brain Metastases
- What is being tested?
- berubicin hydrochloride (RTA 744)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Oct 2007to 1 Jan 2009
- 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
- Histologically-confirmed adenocarcinoma of the breast with at least one evaluable brain lesion ( ≥ 1 cm in one dimension) on contrast-enhanced MRI after WBRT and documented intracranial failure/progression i. Presence of any new lesion(s); or ii. ≥ 25% increase in bi-dimensional measurement of existing tumor
- Definitive radiotherapy ≥ 3000 cGy for documented CNS disease completed ≥ 4 weeks prior to initiation of protocol therapy
- ≥ 2 weeks since stereotactic radiosurgery or gamma knife therapy
- ≥ 4 weeks since neurosurgery (open brain or stereotactic brain biopsy). Patients must have completely recovered from the side effects of surgical procedure.
- ≥ 2 weeks since major surgery (other than neurosurgical procedure) and complete recovery from this surgical procedure.
- Most recent chemotherapeutic treatment regimen completed ≥ 2 weeks prior to study entry provided toxicities have resolved.
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- Hormone receptor positive patients must have progressed on one prior hormonal AND at least one prior chemotherapy course in the metastatic setting.
- Hormone receptor negative patients must have progressed on at least one prior chemotherapy course in the metastatic setting.
- Her2 positive patients must have progressed on at least one prior chemotherapeutic and one Her2-targeted combination course in the metastatic setting.
- Life expectancy ≥ 12 weeks.
- Patients receiving corticosteroids must have been on a stable dose for 2 weeks prior to study enrollment.
- LVEF ≥ 50% on MUGA or ECHO
- ECOG performance status of 0-2.
- Laboratory values confirmed within 14 days of initiation of study therapy: Granulocytes ≥ 1,500/μL; Lymphocytes ≥ 1,000/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 9 gm/dL; Total Bilirubin < 1.5 times upper limit of normal (ULN); ALT and AST < 1.5 times ULN (< 5 times ULN in patients with liver metastases); Creatinine < 1.5 times ULN
- Women of childbearing potential must have negative serum pregnancy test, and must agree to use adequate contraceptive method during administration of study treatment and for three months after completing treatment.
- Cognitive ability to provide written informed consent and comply with study requirements including follow-up procedures.
Who cannot join
- Evidence of new or progressive metastatic disease in the brainstem or intramedullary upper spinal cord. (Metastases in the thalamus are allowed).
- Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology. (Discrete dural metastases are permitted.)
- Evidence of impending herniation on baseline MRI.
- Evidence of CNS hemorrhage on baseline MRI (within 14 days of study enrollment).
- Grade 3 or 4 motor, sensory, or cranial neuropathy symptoms; Grade 3 or 4 seizures, headache or nausea/vomiting.
- Evidence of bleeding diathesis, coagulopathy or requirement for therapeutic anticoagulation.
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- Total lifetime, cumulative anthracycline dose > 350 mg/m2.
- Impaired cardiac function or other significant cardiac disease or arrhythmia of any type including: Complete left bundle branch block; Severe aortic stenosis iii. Obligate use of a cardiac pacemaker; ST depression of > 1mm in ≥ 2 leads and/or T wave inversions in ≥ 2 contiguous leads; Congenital long QT syndrome; History or presence of ventricular or atrial arrhythmia; Clinically significant bradycardia; QTc > 480 msec on EKG; Uncontrolled hypertension, history of labile hypertension or history of poor compliance with anti-hypertensive regimen; New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF); History of myocardial infarction within the past 6 months within the past 6 months
- Concurrent or recent (within 4 weeks prior to randomization) medication(s) that may interfere with study treatment or results, i.e., immunosuppressants other than corticosteroids, enzyme-inducing anti-epileptics and agents that prolong the QTc.
- Concurrent or planned hormonal, chemotherapeutic, experimental, or targeted biologic therapy.
- Any of the following concurrent severe or uncontrolled medical condition which could compromise participation in the study: Uncontrolled diabetes; Active or uncontrolled infection; Acute or chronic liver disease (i.e. hepatitis, cirrhosis); Patients having a contraindication to MRI imaging
- Pregnant
- Inability to comply with study and/or follow-up procedures.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Presbyterian Health Care
Charlotte, North Carolina, 28204
Texas Oncology, PA
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 25184
Moses Cone Regional Cancer Center
Greensboro, North Carolina, 27403
Virginia Oncology Associates
Newport News, Virginia, 23606
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
Forsyth Regional Cancer Center
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase II Efficacy and Tolerability Study of RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases
The purpose of this study is to determine whether RTA 744 is effective in the treatment of breast cancer that has metastasized to the brain.
Read the detailed description
RTA 744 is a novel, anthracycline that has shown the ability to circumvent ATP-binding cassette transporters (Multidrug Resistance Protein 1, Breast Cancer Resistance Protein, P-glycoprotein) in vitro. This action enables RTA 744 to penetrate across the blood brain barrier. In a Phase I safety study, RTA 744 was shown to be generally well tolerated in patients with recurrent glioblastoma multiforme (GBM). Additionally, anti-tumor activity was observed. Breast cancer is known to be sensitive to anthracycline therapy. Based on the preliminary Phase I clinical results and the sensitivity of breast cancer to anthracycline therapy, this Phase II study will investigate the safety and efficacy of RTA 744 in patients with breast cancer and metastatic disease to the brain which has progressed following whole brain irradiation.
- Conditions
- Brain Metastases
- Being tested
- berubicin hydrochloride (RTA 744)
- Keywords
- brain metastases, breast cancer
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
berubicin hydrochloride (RTA 744)Drug
| Study group | Role | What they receive |
|---|---|---|
| RTA 744 | Experimental | Not described Receives: Drug: berubicin hydrochloride (RTA 744) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of RTA 744 in reducing intracranial tumor on contrast-enhanced MRI of breast cancer patients with progression of brain metastases following whole brain radiotherapy (WBRT).
Measured: 21 Days
Secondary outcomes (7)
To evaluate the efficacy of RTA 744 on intracranial tumor as measured by intracranial objective response rate (Intracranial ORR) determined by modified RECIST criteria and by volumetric analysis.
Measured: 18 weeks
To evaluate overall objective response rate after administration of RTA 744.
Measured: 18 weeks
To evaluate the efficacy of RTA 744 on intracranial tumor as measured by intracranial Time To Progression.
Measured: 18 weeks
To evaluate progression free survival (PFS) after administration of RTA 744.
Measured: 18 weeks
To evaluate overall survival (OS) after administration of RTA 744.
Measured: 18 weeks
To evaluate the safety and tolerability of RTA 744 administered at 7.5 mg/m2/day for 3 consecutive days on a 21-day cycle.
Measured: 18 weeks
To evaluate the impact of RTA 744 on quality of life through the FACT-B and modified FACT-Br questionnaires.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study start31 Oct 2007
- Primary completion1 Dec 2008
- Study completion1 Jan 2009
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538343
- Sponsor's protocol ID
- RTA 744-C-0703
- Status last verified
- May 2025
- First submitted
- 28 Sep 2007
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Efficacy and Tolerability Study of RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases
- ClinicalTrials.gov ID
- NCT00538343
- Acronym / sponsor ID
- RTA 744-C-0703
- Conditions
- Brain Metastases
- Keywords
- brain metastases, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2007 (actual)
- Primary completion
- 1 Dec 2008 (actual)
- Study completion
- 1 Jan 2009 (actual)
- First posted
- 2 Oct 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.
The purpose of this study is to determine whether RTA 744 is effective in the treatment of breast cancer that has metastasized to the brain.
Detailed description
RTA 744 is a novel, anthracycline that has shown the ability to circumvent ATP-binding cassette transporters (Multidrug Resistance Protein 1, Breast Cancer Resistance Protein, P-glycoprotein) in vitro. This action enables RTA 744 to penetrate across the blood brain barrier. In a Phase I safety study, RTA 744 was shown to be generally well tolerated in patients with recurrent glioblastoma multiforme (GBM). Additionally, anti-tumor activity was observed. Breast cancer is known to be sensitive to anthracycline therapy. Based on the preliminary Phase I clinical results and the sensitivity of breast cancer to anthracycline therapy, this Phase II study will investigate the safety and efficacy of RTA 744 in patients with breast cancer and metastatic disease to the brain which has progressed following whole brain irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RTA 744 | Experimental | Drug: berubicin hydrochloride (RTA 744) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically-confirmed adenocarcinoma of the breast with at least one evaluable brain lesion ( ≥ 1 cm in one dimension) on contrast-enhanced MRI after WBRT and documented intracranial failure/progression i. Presence of any new lesion(s); or ii. ≥ 25% increase in bi-dimensional measurement of existing tumor
- Definitive radiotherapy ≥ 3000 cGy for documented CNS disease completed ≥ 4 weeks prior to initiation of protocol therapy
- ≥ 2 weeks since stereotactic radiosurgery or gamma knife therapy
- ≥ 4 weeks since neurosurgery (open brain or stereotactic brain biopsy). Patients must have completely recovered from the side effects of surgical procedure.
- ≥ 2 weeks since major surgery (other than neurosurgical procedure) and complete recovery from this surgical procedure.
Key exclusion criteria (13 listed)
- Evidence of new or progressive metastatic disease in the brainstem or intramedullary upper spinal cord. (Metastases in the thalamus are allowed).
- Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology. (Discrete dural metastases are permitted.)
- Evidence of impending herniation on baseline MRI.
- Evidence of CNS hemorrhage on baseline MRI (within 14 days of study enrollment).
- Grade 3 or 4 motor, sensory, or cranial neuropathy symptoms; Grade 3 or 4 seizures, headache or nausea/vomiting.
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 |
|---|---|---|
| berubicin hydrochloride (RTA 744) | Drug | RTA 744 |
Primary outcome
To evaluate the efficacy of RTA 744 in reducing intracranial tumor on contrast-enhanced MRI of breast cancer patients with progression of brain metastases following whole brain radiotherapy (WBRT).
Time frame: 21 Days
7 secondary outcomes
To evaluate the efficacy of RTA 744 on intracranial tumor as measured by intracranial objective response rate (Intracranial ORR) determined by modified RECIST criteria and by volumetric analysis.
Time frame: 18 weeks
To evaluate overall objective response rate after administration of RTA 744.
Time frame: 18 weeks
To evaluate the efficacy of RTA 744 on intracranial tumor as measured by intracranial Time To Progression.
Time frame: 18 weeks
To evaluate progression free survival (PFS) after administration of RTA 744.
Time frame: 18 weeks
To evaluate overall survival (OS) after administration of RTA 744.
Time frame: 18 weeks
To evaluate the safety and tolerability of RTA 744 administered at 7.5 mg/m2/day for 3 consecutive days on a 21-day cycle.
Time frame: 18 weeks
To evaluate the impact of RTA 744 on quality of life through the FACT-B and modified FACT-Br questionnaires.
Time frame: 18 weeks
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing berubicin hydrochloride (RTA 744) in people with Brain Metastases, run by Biogen at 7 sites in United States.
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 13 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 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 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 was stopped early (reason given: Business Decision). 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?
To evaluate the efficacy of RTA 744 in reducing intracranial tumor on contrast-enhanced MRI of breast cancer patients with progression of brain metastases following whole brain radiotherapy (WBRT). (time frame: 21 Days). 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 29 May 2025.