Breast NeoplasmsPhase 2NCT00446030
Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer
A Phase 2 study testing Docetaxel, Doxorubicin and Carboplatin in people with Breast Neoplasms, run by Sanofi at 1 site in United States.
Trial summary
This is a phase II, open-label, multicenter, pilot study of the safety and efficacy of two Docetaxel-based regimens plus bevacizumab for the adjuvant treatment of participants with node positive or high risk node negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Docetaxel, Doxorubicin and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants who met the following criteria were eligible for this study:
- Woman aged 18 to 70 years, inclusive
- Had histologically proven breast cancer with the most recent surgery done for breast cancer up to 60 days prior to study registration
- Had definitive surgical treatment - either mastectomy, or breast conserving surgery with axillary lymph node dissection (or sentinel lymph node biopsy) for operable breast cancer (T1-3, clinical N0-1, and M0)
- Must have been either "lymph node positive" or "high risk lymph node negative"
- Were lymph node positive participants who had at least 1 axillary lymph node involved by breast cancer. (with lymph node metastasis >0.2 mm)
Show all 26Show fewer
- Were high risk lymph node negative participants had no lymph node involvement and at least 1 of the following factors:
- tumor size >2 cm
- estrogen receptor (ER) and progesterone receptor (PR) status negative
- histologic and/or nuclear Grade 2/3
- age <35 years
- Were participants with the Human Epidermal growth factor Receptor 2 (HER2/neu) status (positive or negative) known at the time of signing the informed consent
- Had the estrogen and progesterone receptor status known prior to study registration
- Had Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Had normal cardiac function, confirmed by left ventricular ejection fraction (LVEF) or shortening fraction (echocardiography [ECHO] or multiple-gated acquisition [MUGA] scan respectively)
- Had the following hematology criteria confirmed within 2 weeks prior to study registration:
- Absolute neutrophil count (ANC) >1,500/microL
- Platelets >100,000/microL
- Hemoglobin ≥ 9 g/dL
- Met hepatic function evaluation criteria for bilirubin and AST levels within 2 weeks prior to study registration
- Had completed staging work-up within 35 days (within 1 year for mammography or breast magnetic resonance imaging (MRI) prior to study registration
- May have had MammoSite® brachytherapy radiation when performed immediately following surgery and prior to receiving chemotherapy. The balloon catheter must have been removed at least 28 days prior to the start of study treatment
- May have had bilateral, synchronous breast cancer provided one primary tumor met the staging criteria
- Women of child bearing potential must have had a negative pregnancy test within 14 days prior to day 1 cycle 1
- Had consented to using an effective, non-hormonal method of contraception while receiving study treatment and for at least six (6) months following the last dose of bevacizumab, and must have been advised not to breast feed for at least six (6) months following the last dose of bevacizumab.
- Signed an informed consent prior to beginning any protocol-specific procedures, and had documented expected cooperation during the study treatment and follow-up periods
Who cannot join
- Participants with the following criteria were excluded from this study:
- Had prior systemic anticancer therapy for invasive breast cancer (immunotherapy,hormonotherapy, chemotherapy)
- Had prior anthracycline therapy, taxoids, or platinum salts for any malignancy
- Had prior radiation therapy for breast cancer or any radiotherapy to the chest wall for any other malignancy
- Was pregnant or lactating
- Had pre-existing motor or sensory neurotoxicity of a severity >Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 3.0
Show all 46Show fewer
- Had cardiac disease or risk for same as follows:
- Any documented myocardial infarction
- Angina pectoris that required the use of anti-anginal medication
- Any history of documented congestive heart failure
- Grade 3 or Grade 4 cardiac arrhythmia (NCI CTCAE, version 3.0)
- Clinically significant valvular heart disease
- Had cardiomegaly
- Had poorly controlled hypertension, i.e., diastolic greater than 100 mmHg. (Participants who were well controlled on medication were eligible)
- Were currently receiving medications administered for cardiac arrhythmia, angina or congestive heart failure (e.g., digitalis, beta-blockers, calcium channel-blockers), that alter cardiac conduction, unless the medications were administered for other reasons (e.g., hypertension)
- Had other serious illness or medical conditions including
- History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that prohibited the understanding and giving of informed consent
- Active uncontrolled infection
- Active peptic ulcer
- Unstable diabetes mellitus
- with symptomatic, intrinsic lung disease resulting in dyspnoea at rest
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Urine protein:creatinine ratio >1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, inflammatory bowel disease or other gastrointestinal condition increasing the risk of perforation within 6 months of beginning chemotherapy
- Serious, non-healing wound, ulcer, or bone fracture
- Known central nervous system (CNS) disease
- History of stroke or transient ischemic attack (TIA)
- Known hepatic cirrhosis
- Had past or current history of neoplasm other than breast carcinoma, except for:
- Curatively treated non-melanoma skin cancer
- In situ carcinoma of the cervix
- Other cancer curatively treated and with no evidence of disease for at least 10 years
- Ductal carcinoma in-situ (DCIS) of the breast
- Lobular carcinoma in-situ (LCIS) of the breast
- Was currently on therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention of breast cancer
- Had chronic treatment with corticosteroids unless initiated >6 months prior to study registration and at low dose (<20 mg methylprednisolone or equivalent)
- Had concurrent treatment with ovarian hormonal replacement therapy
- Had concurrent treatment with other experimental drugs
- Had concurrent treatment with any other anticancer therapy
- Was male
- Had known hypersensitivity to Chinese hamster ovary products or other recombinant human or humanized antibodies and/or hypersensitivity to any of the study drugs or their ingredients (e.g., polysorbate 80 in docetaxel)
- Had minor surgical procedures within 7 days prior to day 1 of study treatment; or major surgical procedures within 28 days prior to day 1 of study treatment or had any anticipated a surgical procedure during the chemotherapy portion of this study
- Was directly (or was a relative of the study staff) involved in the conduct of the protocol
- Had a mental condition or psychiatric disorder rendering her unable to understand the nature, scope, and possible consequences of the study
- Was unlikely to comply with protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Phase II, Open-Label, Multicenter, Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer
This is a phase II, open-label, multicenter, pilot study of the safety and efficacy of two Docetaxel-based regimens plus bevacizumab for the adjuvant treatment of participants with node positive or high risk node negative breast cancer.
The primary objective of this study was to evaluate the cardiac safety, and the secondary objectives were to evaluate safety and toxicity of participants treated with bevacizumab ± trastuzumab administered with 2 different docetaxel-based combination regimens.
This study was originally designed to also evaluate disease-free survival (DFS) and overall survival (OS); however, based on a protocol amendment, follow-up was shortened from 10 years to 2 years, and the efficacy endpoints of disease free survival and overall survival were deleted from the protocol.
- Conditions
- Breast Neoplasms
- Being tested
- Docetaxel, Doxorubicin, Carboplatin, Cyclophosphamide, Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere®
75 mg/m^2 administered IV on Day 1 for Cycles 1-6
All participants received a prophylactic steroid regimen prior to each dose of docetaxel - Dexamethasone 8 mg orally 12 hours prior to docetaxel, dexamethasone 10 mg IV just prior the docetaxel infusion and 8 mg orally 12 hours after docetaxel administration. If a participant had not taken their oral dexamethasone the evening prior to receiving docetaxel, the dose of the pre-docetaxel infusion of dexamethasone was increased from 10 mg IV to 15 mg IV. A Dexamethasone 8 mg equivalent may have been used (dexamethasone 8 mg = methylprednisolone 40 mg = prednisone 50 mg = prednisolone 50 mg).
DoxorubicinDrug
50 mg/m^2 administered IV on Day 1 for Cycles 1-6
CarboplatinDrug
Also called Gemzar®
6 mg/mL/min (target area under the curve [AUC] dose) administered IV on Day 1 for Cycles 1-6
CyclophosphamideDrug
500 mg/m^2 administered IV on Day 1 for Cycles 1-6
TrastuzumabDrug
A single loading dose of 8 mg/kg administered IV on Day 2 for Cycle 1, and 6 mg/kg administered IV on Day 1 for Cycles 2-6 and for maintenance therapy
BevacizumabDrug
15 mg/kg administered IV on Day 1 for Cycles 1-6, and for maintenance therapy
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1: TAC + Bevacizumab | Experimental | Human epidermal growth factor receptor-2 (HER2) negative participants stratified at registration, were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
All participants were administered prophylactic recombinant Granulocyte Colony Stimulating Factor (G-CSF) during chemotherapy, based on a dose recommended by the manufacturer. For participants with estrogen receptor (ER) or progesterone receptor (PR) positive tumors, anti-estrogen therapy was recommended. Participants could receive radiation therapy at the discretion of the treating medical and radiation oncologist. Receives: Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Bevacizumab |
| Stratum 2: TCH + Bevacizumab | Experimental | HER2 positive participants stratified at registration, were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
All participants were administered prophylactic recombinant Granulocyte Colony Stimulating Factor (G-CSF) during chemotherapy, based on a dose recommended by the manufacturer. For participants with estrogen receptor (ER) or progesterone receptor (PR) positive tumors, anti-estrogen therapy was recommended. Participants could receive radiation therapy at the discretion of the treating medical and radiation oncologist. Receives: Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF)
The percentage of participants with Grade 3/4 clinical CHF was calculated. Grade 3/4 CHF symptoms included cardiac failure congestive, cardiomyopathy, and left ventricular dysfunction (LVEF). Echocardiography (ECG) or multiple-gated acquisition (MUGA) scans were scheduled after Cycles 3 and 6 of chemotherapy, after every 3rd cycle of trastuzumab alone, at end of therapy and every 6 months at follow-up to measure changes in LVEF. Clinical symptoms e.g., shortness of breath, tachycardia, cough, neck vein distention, cardiomegaly, hepatomegaly were further investigated for CHF.
Measured: up to 2 years
Secondary outcomes (1)
Disease-free Survival (DFS) & Overall Survival (OS) of Participants
DFS is the time from study registration until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. For participants who are removed from the study follow-up prior to documentation of the tumor recurrence, DFS will be censored at the last date the participant was known to be disease-free.
OS is the time from date of registration to date of death. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicki Erickson, MSN, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446030
- Sponsor's protocol ID
- DOCET_L_00713
- Status last verified
- Jun 2012
- First submitted
- 8 Mar 2007
- Last updated
- 26 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hurvitz SA, Bosserman LD, Chan D, Hagenstad CT, Kass FC, Smith FP, Rodriguez GI, Childs BH, Slamon DJ. Cardiac safety results from a phase II, open-label, multicenter, pilot study of two docetaxel-based regimens plus bevacizumab for the adjuvant treatment of subjects with node-positive or high-risk node-negative breast cancer. Springerplus. 2014 May 12;3:244. doi: 10.1186/2193-1801-3-244. eCollection 2014.
PubMed 24860718
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicenter, Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT00446030
- Acronym / sponsor ID
- DOCET_L_00713
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Mar 2007 (estimated)
- Results
- Posted 4 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, open-label, multicenter, pilot study of the safety and efficacy of two Docetaxel-based regimens plus bevacizumab for the adjuvant treatment of participants with node positive or high risk node negative breast cancer.
The primary objective of this study was to evaluate the cardiac safety, and the secondary objectives were to evaluate safety and toxicity of participants treated with bevacizumab ± trastuzumab administered with 2 different docetaxel-based combination regimens.
This study was originally designed to also evaluate disease-free survival (DFS) and overall survival (OS); however, based on a protocol amendment, follow-up was shortened from 10 years to 2 years, and the efficacy endpoints of disease free survival and overall survival were deleted from the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratum 1: TAC + Bevacizumab | Experimental | Drug: Docetaxel, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: BevacizumabHuman epidermal growth factor receptor-2 (HER2) negative participants stratified at registration, were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks. All participants were administered prophylactic recombinant Granulocyte Colony Stimulating Factor (G-CSF) during chemotherapy, based on a dose recommended by the manufacturer. For participants with estrogen receptor (ER) or progesterone receptor (PR) positive tumors, anti-estrogen therapy was recommended. Participants could receive radiation therapy at the discretion of the treating medical and radiation oncologist. |
| Stratum 2: TCH + Bevacizumab | Experimental | Drug: Docetaxel, Drug: Carboplatin, Drug: Trastuzumab, Drug: BevacizumabHER2 positive participants stratified at registration, were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks. All participants were administered prophylactic recombinant Granulocyte Colony Stimulating Factor (G-CSF) during chemotherapy, based on a dose recommended by the manufacturer. For participants with estrogen receptor (ER) or progesterone receptor (PR) positive tumors, anti-estrogen therapy was recommended. Participants could receive radiation therapy at the discretion of the treating medical and radiation oncologist. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Woman aged 18 to 70 years, inclusive
- Had histologically proven breast cancer with the most recent surgery done for breast cancer up to 60 days prior to study registration
- Had definitive surgical treatment - either mastectomy, or breast conserving surgery with axillary lymph node dissection (or sentinel lymph node biopsy) for operable breast cancer (T1-3, clinical N0-1, and M0)
- Must have been either "lymph node positive" or "high risk lymph node negative"
- Were participants with the Human Epidermal growth factor Receptor 2 (HER2/neu) status (positive or negative) known at the time of signing the informed consent
Key exclusion criteria (46 listed)
- Had prior systemic anticancer therapy for invasive breast cancer (immunotherapy,hormonotherapy, chemotherapy)
- Had prior anthracycline therapy, taxoids, or platinum salts for any malignancy
- Had prior radiation therapy for breast cancer or any radiotherapy to the chest wall for any other malignancy
- Was pregnant or lactating
- Had pre-existing motor or sensory neurotoxicity of a severity >Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 3.0
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 |
|---|---|---|
| DocetaxelAlso: Taxotere®75 mg/m^2 administered IV on Day 1 for Cycles 1-6 All participants received a prophylactic steroid regimen prior to each dose of docetaxel - Dexamethasone 8 mg orally 12 hours prior to docetaxel, dexamethasone 10 mg IV just prior the docetaxel infusion and 8 mg orally 12 hours after docetaxel administration. If a participant had not taken their oral dexamethasone the evening prior to receiving docetaxel, the dose of the pre-docetaxel infusion of dexamethasone was increased from 10 mg IV to 15 mg IV. A Dexamethasone 8 mg equivalent may have been used (dexamethasone 8 mg = methylprednisolone 40 mg = prednisone 50 mg = prednisolone 50 mg). | Drug | Stratum 1: TAC + Bevacizumab, Stratum 2: TCH + Bevacizumab |
| Doxorubicin50 mg/m^2 administered IV on Day 1 for Cycles 1-6 | Drug | Stratum 1: TAC + Bevacizumab |
| CarboplatinAlso: Gemzar®6 mg/mL/min (target area under the curve [AUC] dose) administered IV on Day 1 for Cycles 1-6 | Drug | Stratum 2: TCH + Bevacizumab |
| Cyclophosphamide500 mg/m^2 administered IV on Day 1 for Cycles 1-6 | Drug | Stratum 1: TAC + Bevacizumab |
| TrastuzumabA single loading dose of 8 mg/kg administered IV on Day 2 for Cycle 1, and 6 mg/kg administered IV on Day 1 for Cycles 2-6 and for maintenance therapy | Drug | Stratum 2: TCH + Bevacizumab |
| Bevacizumab15 mg/kg administered IV on Day 1 for Cycles 1-6, and for maintenance therapy | Drug | Stratum 1: TAC + Bevacizumab, Stratum 2: TCH + Bevacizumab |
Primary outcome
Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF)
Time frame: up to 2 years
The percentage of participants with Grade 3/4 clinical CHF was calculated. Grade 3/4 CHF symptoms included cardiac failure congestive, cardiomyopathy, and left ventricular dysfunction (LVEF). Echocardiography (ECG) or multiple-gated acquisition (MUGA) scans were scheduled after Cycles 3 and 6 of chemotherapy, after every 3rd cycle of trastuzumab alone, at end of therapy and every 6 months at follow-up to measure changes in LVEF. Clinical symptoms e.g., shortness of breath, tachycardia, cough, neck vein distention, cardiomegaly, hepatomegaly were further investigated for CHF.
1 secondary outcome
Disease-free Survival (DFS) & Overall Survival (OS) of Participants
Time frame: up to 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24860718Hurvitz SA, Bosserman LD, Chan D, Hagenstad CT, Kass FC, Smith FP, Rodriguez GI, Childs BH, Slamon DJ. Cardiac safety results from a phase II, open-label, multicenter, pilot study of two docetaxel-based regimens plus bevacizumab for the adjuvant treatment of subjects with node-positive or high-risk node-negative breast cancer. Springerplus. 2014 May 12;3:244. doi: 10.1186/2193-1801-3-244. eCollection 2014.
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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.
Vicki Erickson, MSN study director
Sanofi
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 Docetaxel, Doxorubicin and Carboplatin in people with Breast Neoplasms, run by Sanofi at 1 site 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 26 inclusion and 46 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 26 Jun 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 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?
Yes. Results are posted in the registry (first posted 4 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00446030, which also lists 1 linked publication.
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 26 Jun 2012.