Breast CancerPhase 2cardioprotecNCT00955890
Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer
A Phase 2 study testing Dexrazoxane hydrochloride in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dexrazoxane hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Feb 2012
- 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
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary infiltrating adenocarcinoma of the breast
- Confirmed by core needle biopsy or incisional biopsy or surgery
- Experienced grade 1 cardiac toxicity during prior anthracycline-based chemotherapy
- At least 2 cycles same anthracycline based chemotherapy are needed
Who cannot join
- Accumulated dose of EPI ≥1000mg/m2,ADM≥550mg/m2
- With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); Prior or Concurrent radiation to heart
- Pregnant or nursing
- Other currently active malignancy except nonmelanoma skin cancer
- Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
- Grade 2 or more Cardiac Toxicity (CTC AE3.0)
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Randomized Phase II Trial Of Interventional Therapy Investigate Cardiac Protection of Dexrazoxane In Women With Breast Cancer Having Experienced Grade 1 Cardiotoxicity During Prior Anthracycline-based Chemotherapy.
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. CTnT/cTnI/ANP/BNP were proved to be used as a biomarker of drug related cardiotoxicity. There are excellent correlations between the total cumulative dose of doxorubicin, the severity of the resulting cardiomyopathy, and the level of serum troponin-T.
Read the detailed description
Patients with breast cancer receiving anthracycline chemotherapy randomized to 3 groups:chemotherapy plus low dose dexrazoxane,chemotherapy plus middle dose dexrazoxane, chemotherapy only.Every patient receive at least 2 cycles anthracycline chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Dexrazoxane hydrochloride
- Keywords
- cardioprotection, anthracycline chemotherapy, 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.
Dexrazoxane hydrochlorideDrug
Also called Dexrazoxane for Injection
pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
Dexrazoxane hydrochlorideDrug
Also called dexrazoxane injection
pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| control arm | No intervention | anthracycline chemotherapy only |
| low dose dexrazoxane group | Experimental | anthracycline chemotherapy plus low dose dexrazoxane(10:1) Receives: Drug: Dexrazoxane hydrochloride |
| middle dose dexrazoxane group | Experimental | anthracycline chemotherapy plus middle dose dexrazoxane(15:1) Receives: Drug: Dexrazoxane hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy
Measured: 1 year
Secondary outcomes (1)
Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Enrolled too slow
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.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- xichun Hu, MD, Principal investigator, member of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955890
- Sponsor's protocol ID
- MBC0901 FUCH
- Acronym
- cardioprotec
- Status last verified
- Feb 2012
- First submitted
- 7 Aug 2009
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial Of Interventional Therapy Investigate Cardiac Protection of Dexrazoxane In Women With Breast Cancer Having Experienced Grade 1 Cardiotoxicity During Prior Anthracycline-based Chemotherapy.
- ClinicalTrials.gov ID
- NCT00955890
- Acronym / sponsor ID
- cardioprotec / MBC0901 FUCH
- Conditions
- Breast Cancer
- Keywords
- cardioprotection, anthracycline chemotherapy, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolled too slow
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Aug 2009 (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.
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. CTnT/cTnI/ANP/BNP were proved to be used as a biomarker of drug related cardiotoxicity. There are excellent correlations between the total cumulative dose of doxorubicin, the severity of the resulting cardiomyopathy, and the level of serum troponin-T.
Detailed description
Patients with breast cancer receiving anthracycline chemotherapy randomized to 3 groups:chemotherapy plus low dose dexrazoxane,chemotherapy plus middle dose dexrazoxane, chemotherapy only.Every patient receive at least 2 cycles anthracycline chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control arm | No intervention | –anthracycline chemotherapy only |
| low dose dexrazoxane group | Experimental | Drug: Dexrazoxane hydrochlorideanthracycline chemotherapy plus low dose dexrazoxane(10:1) |
| middle dose dexrazoxane group | Experimental | Drug: Dexrazoxane hydrochlorideanthracycline chemotherapy plus middle dose dexrazoxane(15:1) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed primary infiltrating adenocarcinoma of the breast
Key exclusion criteria (6 listed)
- Accumulated dose of EPI ≥1000mg/m2,ADM≥550mg/m2
- With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); Prior or Concurrent radiation to heart
- Pregnant or nursing
- Other currently active malignancy except nonmelanoma skin cancer
- Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
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 |
|---|---|---|
| Dexrazoxane hydrochlorideAlso: Dexrazoxane for Injectionpink power 250mg/bottle DEX:EPI,10:1 every 3 weeks | Drug | low dose dexrazoxane group, middle dose dexrazoxane group |
| Dexrazoxane hydrochlorideAlso: dexrazoxane injectionpink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks | Drug | middle dose dexrazoxane group |
Primary outcome
Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy
Time frame: 1 year
1 secondary outcome
Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Enrolled too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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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.
xichun Hu, MD principal investigator
member of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexrazoxane hydrochloride in people with Breast Cancer, run by Fudan University at 1 site in China.
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 5 inclusion and 6 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 28 Feb 2012. 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 China. 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: Enrolled too slow). 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?
Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy (time frame: 1 year). 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 28 Feb 2012.