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AzTrials

Breast CancerPhase 2NCT00464646

Therapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer

A Phase 2 study testing Epirubicin, Cyclophosphamide and Docetaxel in people with Breast Cancer, run by NSABP Foundation Inc at 36 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab to treat HER2-positive breast cancer will affect heart function. This study will evaluate: How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab after surgery, will affect breast tumors Side… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Epirubicin, Cyclophosphamide and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
36 sitesin 2 countries
Study dates
May 2007to May 2014
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Conditions for eligibility for patients with LABC (Cohort A):
  • The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.
  • Patients must have clinical Stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla that is greater than or equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.
  • Conditions for eligibility for patients with resected Stage III breast cancer (Cohort B)
  • Patients must have undergone either a total mastectomy or a lumpectomy.
  • Patients must have completed one of the following procedures for evaluation of pathologic nodal status.
Show all 34Show fewer
  • Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes, or
  • Axillary lymphadenectomy without SN isolation procedure.
  • The interval between the last surgery (for breast cancer treatment or staging) and study entry must be no more than 84 days.
  • By pathologic evaluation, ipsilateral nodes must be pN2 or pN3.
  • For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)
  • For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.
  • Conditions for patient eligibility (ALL patients)
  • The patient must have consented to participate and must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
  • Patients must be female.
  • The patient must be greater than or equal to 18 years old.
  • The patient's ECOG performance status must be 0 or 1.
  • The tumor must be invasive adenocarcinoma of the breast on histologic examination.
  • The breast cancer must be determined to be HER2-positive prior to study entry. Assays performed using FISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.
  • At the time of study entry, blood counts must meet the following criteria:
  • Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.
  • Platelet count must be greater than/equal to 100,000/mm3.
  • Hemoglobin must be greater than/equal to 10 g/dL.
  • The following criteria for evidence of adequate hepatic function must be met:
  • total bilirubin must be less than/equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
  • alkaline phosphatase must be less than 2.5 x ULN for the lab; and
  • AST must be less than/equal to 1.5 x ULN for the lab.
  • Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.
  • Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, or PET scan) does not demonstrate metastatic disease, and has adequate hepatic function.
  • Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than/equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan or PET scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are confirmed as benign by x-ray, MRI, or biopsy.
  • Serum creatinine less than/equal to ULN for the lab.
  • Urine protein/creatinine (UPC) ratio must be less than 1.0.
  • All patients must have their LVEF assessed by 2-D echocardiogram within 3 months prior to study entry. (MUGA scan may be substituted for 2-D echocardiogram based on institutional preferences.) The LVEF must be greater than/equal to 55% regardless of the institution's LLN.
  • Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if trastuzumab and bevacizumab therapy can be administered, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and to consider repeating the study if the accuracy is uncertain.

Who cannot join

  • Conditions for patient ineligibility (Cohort A)
  • FNA alone to diagnose the primary tumor.
  • Surgical axillary staging procedure prior to study entry. (Procedures that are permitted include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.
  • Condition for patient ineligibility (Cohort B)
  • Breast reconstruction using tissue expanders or implants at the time of mastectomy.
  • Conditions for patient ineligibility (ALL patients)
Show all 35Show fewer
  • Definitive clinical or radiologic evidence of metastatic disease.
  • Synchronous bilateral invasive breast cancer.
  • History of ipsilateral or contralateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.
  • History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  • Prior therapy with anthracyclines, taxanes, trastuzumab, or bevacizumab for any malignancy.
  • Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.
  • Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible if these medications are discontinued prior to study entry.)
  • Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. These patients are eligible if this therapy is discontinued prior to study entry. (Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy and for at least 6 months after completion of targeted therapy.)
  • Cardiac disease that would preclude the use of the drugs included in the FB-5 treatment regimen. This includes but is not confined to:
  • Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions controlled by medication; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; and clinically significant valvular disease.
  • History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; documented CHF; or documented cardiomyopathy.
  • Uncontrolled hypertension defined as systolic BP greater than 150 mmHg or diastolic BP greater han 90 mmHg, with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
  • History of hypertensive crisis or hypertensive encephalopathy.
  • History of TIA or CVA.
  • History of other arterial thrombotic event within 12 months before study entry.
  • Symptomatic peripheral vascular disease.
  • Any significant bleeding within 6 months before study entry, exclusive of menorrhagia in premenopausal women.
  • Serious or non-healing wound, skin ulcers, or bone fracture.
  • Gastroduodenal ulcer(s) determined by endoscopy to be active.
  • History of GI perforation, abdominal fistulae, or intra-abdominal abscess.
  • Anticipation of need for major surgical procedures (other than the breast surgery required for patients in Cohort A) during study therapy and for at least 3 months following completion of bevacizumab.
  • Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin.
  • Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
  • Sensory/motor neuropathy greater than/equal to grade 2, as defined by the NCI's CTCAE v3.0.
  • Conditions that would prohibit administration of corticosteroids.
  • History of hypersensitivity reaction to drugs formulated with polysorbate 80.
  • Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed according to institutional standards for women of child-bearing potential.)
  • Use of any investigational agent within 4 weeks prior to enrollment in the study.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States35 sites

  • Aultman Hospital

    Canton, Ohio, 44710

  • CCOP, Southeast Cancer Control Consortium

    Charlotte, North Carolina, 28203

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Case Western Reserve/University Hospitals-Ireland Cancer Cntr.

    Cleveland, Ohio, 44106

  • CCOP, Dayton, OH

    Dayton, Ohio, 45429

  • CCOP, Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80224

  • CCOP, Grand Rapids Clnical Oncology Program

    Grand Rapids, Michigan, 49503

  • East Carolina University

    Greenville, North Carolina, 27834

  • CCOP, Michigan Cancer Research Consortium

    Grosse Pointe Woods, Michigan, 48236

  • Clearview Cancer Institute- Huntsville

    Huntsville, Alabama, 35801

  • University of Iowa

    Iowa City, Iowa, 52242

  • Baptist Regional Cancer Institute

    Jacksonville, Florida, 32207

  • CCOP, Kalamazoo, MI

    Kalamazoo, Michigan, 49007

  • Michigan State University - Breslin Cancer Center

    Lansing, Michigan, 48910

  • NortonHealtcare Inc.

    Louisville, Kentucky, 40202

  • Joe Arrington Cancer Research & Treatment Center

    Lubbock, Texas, 79410

  • CCOP, Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • CCOP, Metro-Minnesota

    Minneapolis, Minnesota, 55416

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Kimmel Cancer Center at Jefferson

    Philadelphia, Pennsylvania, 19107

  • Albert Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141-3098

  • Allegheny General Hospital/Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • NSABP Foundation, Inc.

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • CCOP, Columbia River Oncology

    Portland, Oregon, 97225

  • MBCCOP, Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Kaiser Permanente-San Diego

    San Diego, California, 92120

  • Mercy Hospital

    Scranton, Pennsylvania, 18501

  • CCOP, Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • CCOP, Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP, Central Illinois

    Springfield, Illinois, 62526

  • CCOP, Cancer Research for the Ozarks

    Springfield, Missouri, 65804

  • University Hospital and Medical Center - SUNY

    Stony Brook, New York, 11794

  • CCOP, Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

Other trials in United States

Canada1 site

  • University of Montreal Hospital Group

    Montreal, Quebec

Other trials in Canada

About this study

Official title: A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Bevacizumab Given as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or Given as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer

The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab to treat HER2-positive breast cancer will affect heart function. This study will evaluate:

  • How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab after surgery, will affect breast tumors
  • Side effects from adding bevacizumab to chemotherapy and trastuzumab
  • Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect the heart
  • If receiving bevacizumab will have any effect on how patients recover from surgery
Read the detailed description

NSABP FB-5 is a Phase II study for women with HER2-positive invasive breast cancer evaluating a regimen of epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab and bevacizumab in two patient cohorts:

  • Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
  • Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer.

The primary aims of the study are to determine the rate of cardiac events for all patients and the pCR rate in the breast and axillary lymph nodes for Cohort A. Cardiac events will be defined as NYHA Class III/IV congestive heart failure and cardiac death. For Cohort A, secondary aims of the study include determining the rate of pCR in the breast and the cCR rate following the neoadjuvant therapy. The secondary aims also include determining the value of the regimen in improving 5-year RFS and 5-year OS and determining the non-cardiac toxicities of the regimen in all patients.

Patients in Cohort A will receive neoadjuvant therapy consisting of epirubicin plus cyclophosphamide (EC) every 21 days for 4 cycles plus bevacizumab given on Day 1 of Cycle 4 only, followed by docetaxel every 21 days for 4 cycles plus bevacizumab every 21 days for the initial 3 cycles. Patients will also receive weekly trastuzumab beginning with the first cycle of docetaxel and continuing until 1-7 days before surgery. Patients will then have breast surgery (lumpectomy or mastectomy) with axillary staging. Approximately 4-6 weeks following surgery, bevacizumab and trastuzumab will resume and continue every 3 weeks for 13 doses to complete one year of targeted therapy.

Patients in Cohort B will receive adjuvant therapy consisting of EC every 21 days for 4 cycles followed by docetaxel every 21 days for 4 cycles. Beginning with the first cycle of docetaxel, patients will also receive bevacizumab every 21 days for 4 cycles and weekly trastuzumab until 3 weeks after the last docetaxel dose. Beginning 3 weeks after the last dose of docetaxel, both bevacizumab and trastuzumab will then be given every 3 weeks for 13 doses to complete 1 year of targeted therapy.

Cardiac monitoring will be conducted for both cohorts. For Cohort A, LVEF assessments will be conducted at baseline, post-EC, 2-4 weeks following surgery (about 6 months from study entry), and 9, 12, 15, and 18 months from study entry. For Cohort B, LVEF assessments will be conducted at baseline, post-EC, and 6, 9, 12, 15, and 18 months from study entry. The preferred method for LVEF assessment is 2-D echocardiogram; however, LVEF assessment by MUGA scan is permitted.

Patient follow-up will continue for 5 years following study entry.

The FB-5 sample size is 105 patients.

Conditions
Breast Cancer
Keywords
NSABP, Epirubicin, Cyclophosphamide, Docetaxel, Trastuzumab, Bevacizumab, Neoadjuvant Therapy, HER2, Locally Advanced Breast Cancer, Adjuvant Therapy, Pathologic Stage III Breast Cancer, Inflammatory Breast Cancer
Medical subject headings
Breast Neoplasms, Inflammatory Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpirubicinDrug

    Also called Ellence

    Both Cohorts: Epirubicin 90 mg/m2 IV every 21 days x 4 cycles

  • CyclophosphamideDrug

    Both Cohorts: Cyclophosphamide 600 mg/m2 IV every 21 days x 4 cycles

  • DocetaxelDrug

    Also called Taxotere

    Both Cohorts: Docetaxel 100 mg/m2 IV on Day 1 every 21 days x 4 cycles

  • TrastuzumabDrug

    Also called Herceptin

    Cohort A: Pre-op therapy - 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly (16+ weeks) until 1-7 days prior to surgery. Post-operative therapy (beginning no sooner than 28 days after surgery and continuing every 3 weeks x 13 doses) - 8 mg/kg IV first post-op dose, then subsequent doses at 6 mg/kg IV

    Cohort B: 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly on days 1, 8, and 15. Three (3) weeks after last dose of docetaxel, 6 mg/kg IV and continuing every 3 weeks x 13 doses

  • BevacizumabDrug

    Also called Avastin

    Cohort A: Cycles 1-4, 15 mg/kg IV on day 1 of cycle 4 only; Cycles 5-7, 15 mg/kg IV on day 1 every 21 days x 3 cycles; post-operative therapy (beginning no sooner than 28 days after surgery), 15 mg/kg IV every 3 weeks x 13 doses

    Cohort B: Cycles 5-8, 15 mg/kg IV on day 1 every 21 days x 4 cycles; beginning 3 weeks after last dose of docetaxel, 15 mg/kg IV every 3 weeks x 13 doses

Study groups in NCT00464646
Study groupRoleWhat they receive
1Experimental* Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC) * Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Trastuzumab; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)

    The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.

    Measured: Assessed at time of surgery on average at 8 months

  2. Number of Participants With Cardiac Events

    The number of cardiac events defined as NYHA Class III/IV CHF and cardiac death.To determine the rate of cardiac events (NYHA Class III/IV CHF and cardiac death) of a regimen of EC followed by THA when administered to: Cohort A as neoadjuvant therapy for HER-2 positive locally advanced (clinical stage IIIA, IIIB or IIIC breast cancer or Cohort B as adjuvant therapy for resected HER2-positive pN2 or pN3 (pathologic stage III) breast cancer. The number of participants with one or more cardiac events are being reported.

    Measured: Cohort A: Baseline, post-treatment with EC, 2-4 weeks after surgery, and 9, 12, 15, and 18 months from study entry. Cohort B: Baseline, post-treatment with EC, 2-3 weeks after the last dose of docetaxel, and 6, 9, 12, 15, and 18 months from study entry.

Secondary outcomes (6)

  1. Number of Participants With no Histologic Evidence of Invasive Tumor Cells in the Surgical Breast Specimen.

    The determination of pCR will be performed by the local pathologist following examination of tissue (breast and nodes) removed at the time of surgery.

    Measured: Assessed at the time of surgery

  2. Clinical Complete Response (cCR)

    cCR following the last dose of docetaxel (Cohort A). cCR is detemined by tumor measurement by physical exam at baseline: target lesions greater than or equal to 2.0 cm; non-target lesions greater than or equal to 2.0 cm. cCR assessment at other timepoints: resolution of all target and non-target lesions identified at baseline, and no new lesions or other signs of disease progression.

    Measured: Determined at baseline, 2-3 weeks after the last EC dose, 2-4 weeks after last Docetaxel dose-before surgery.

  3. Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)

    Measured: Before each cycle of pre-op Rx; 2-4 wks after the last docetaxel dose; 2-4 wks post surgery (Cohort A); every 6 wks during post-op Rx (Cohort A); every 6 wks during targeted therapy alone (Cohort B); RT complications assessed at 12 mos from study entry

  4. Recurrence-free Survival

    To determine the five-year RFS.

    Measured: From the first dose of study therapy until the date of recurrence or for a maximum of five (5) years from study entry

  5. Overall Survival

    Death from any cause during the 5 years from study entry.

    Measured: From the first dose of study therapy until the date of death or for a maximum of five (5) years from study entry

  6. Percentage of Participants With Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)

    The percentage of patients with surgical complications (from mastectomy, lumpectomy, and axillary staging procedures).

    Measured: 2-4 weeks after surgery and at 9 and 12 months from study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2009
  4. Study completionMay 2014

Resources

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
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00464646
Sponsor's protocol ID
NSABP FB-5
Status last verified
Oct 2021
First submitted
19 Apr 2007
Last updated
25 Oct 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epirubicin, Cyclophosphamide and Docetaxel in people with Breast Cancer, run by NSABP Foundation Inc at 36 sites in 2 countries.

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 34 inclusion and 35 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 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Canada. 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 26 Sep 2012). 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?

Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A) (time frame: Assessed at time of surgery on average at 8 months). The study lists 2 primary outcomes in all. 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 NCT00464646.

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 25 Oct 2021.

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