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Breast AdenocarcinomaPhase 3NCT02037529

Eribulin Mesylate or Paclitaxel as First- or Second-Line Therapy in Treating Patients With Recurrent Stage IIIC-IV Breast Cancer

A Phase 3 study testing Eribulin Mesylate, Laboratory Biomarker Analysis and Paclitaxel in people with Breast Adenocarcinoma and HER2/Neu Negative, run by Academic and Community Cancer Research United at 39 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This randomized phase III trial studies how well eribulin mesylate or paclitaxel work as first- or second-line therapy in treating patients with stage IIIC-IV breast cancer that has come back. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Eribulin Mesylate, Laboratory Biomarker Analysis and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
39 sitesUnited States
Study dates
17 Jan 2014to 31 Oct 2024
Phase
Phase 3
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent document signed and dated by patient
  • Histologic confirmation of invasive adenocarcinoma originating in the breast
  • Stage IV disease or stage IIIC disease (using the 7th edition American Joint Committee on Cancer [AJCC] criteria) not amenable to local therapy
  • Clinical or radiographic evidence of disease progression
  • Documentation of HER2 negative breast cancer at the time of protocol registration; (Note: HER2 negativity is defined as 0 or 1+ by immunohistochemistry OR nonamplified or equivocal by fluorescence in situ hybridization [FISH]; status may be defined on the basis of historic results on the breast primary or a metastatic site, whichever is most recent; repeat biopsies are not required for participation in this protocol)
  • Known hormone receptor status at the time of protocol registration; (Note: estrogen receptor [ER] and/or progesterone receptor [PgR] status are considered positive with a cut-off of >= 1% invasive tumor cells; status may be defined on the basis of historic results on the breast primary or a metastatic site, whichever is most recent; repeat biopsies are not required for participation in this protocol)
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  • Patients must demonstrate resolution of all toxicities related to prior chemotherapy, endocrine therapy, targeted therapy, or biologic therapy to grade =< 1, including peripheral neuropathy, with the exception of alopecia (any grade permissible)
  • No more than one prior chemotherapy regimen for advanced or metastatic breast cancer is allowed; prior chemotherapy for metastatic disease must have been completed >= 14 days prior to randomization
  • Any single agent therapy, and any combination of cytotoxic, endocrine, biological targeted agents, and/or humanized antibodies, scheduled to be administered as a preplanned treatment, given concomitantly, sequentially or both, is considered one regimen
  • Planned neoadjuvant chemotherapy and postoperative adjuvant chemotherapy is considered one regimen
  • If the dosing of one or more of the chemotherapy components of a regimen must be reduced for toxicity, the modified version of the original regimen is not considered a new regimen
  • If one or more of the chemotherapy components of a regimen must be omitted for toxicity, the modified version of the original regimen is not considered a new regimen
  • If one of the chemotherapy components of a regimen must be replaced with another similar drug of the same therapeutic class, the modified version of the original regimen is not considered a new regimen; however, if a new component, dissimilar to any of the original components, is added to the regimen, the modified version is considered a new regimen
  • If chemotherapy is interrupted for surgery or radiotherapy and then continues with an unchanged schedule and components, treatment is considered as one regimen despite the interruption
  • Prior treatment may include a taxane as per the following criteria:
  • Prior taxane (including paclitaxel) in the adjuvant or neoadjuvant setting is allowed, provided that the interval between the completion of (neo)adjuvant therapy and disease recurrence is > 12 months
  • Prior taxane in the metastatic setting is allowed, provided that the agent administered in the metastatic setting was not standard paclitaxel
  • Any number of prior endocrine therapies is allowed and must be discontinued prior to randomization
  • Any number of biologic therapies (e.g., bevacizumab) or immunotherapies is allowed in the absence of co-administered chemotherapy and must have been completed >= 28 days prior to randomization
  • Prior treatment with an investigational agent is allowed but must have been completed >= 28 days prior to randomization with resolution of all treatment-related toxicities to grade =< 1.
  • Minor surgical procedures must be completed >= 7 days prior to randomization with documentation of adequate recovery from associated complications to grade =< 1; these include (but are not limited to) laparoscopy, thoracoscopy, bronchoscopy, mediastinoscopy, endoscopic ultrasonography, skin biopsy, percutaneous needle biopsy, and routine dental procedures; as a precautionary measure, it is recommended, but not strictly required, that placement of a central venous access device, thoracentesis, or paracentesis be done 7 days before the initiation of protocol directed chemotherapy with documentation of adequate recovery from associated complications to grade =< 1
  • Major surgical procedures and open biopsies must be completed >= 28 days prior to randomization with documentation of adequate recovery from associated complications to grade =< 1
  • Prior radiotherapy must be completed >= 14 days prior to randomization with documentation of adequate recovery from associated toxicities to grade =< 1
  • Treatment with bisphosphonates or denosumab is allowed and recommended per the standard of care
  • Therapeutic anticoagulation is allowed for patients on a stable dose of warfarin or low molecular weight heparin
  • Measurable disease is defined as at least one lesion that can be accurately measured with the longest diameter as >= 1.0 cm by computed tomography (CT) scan or >= 1.0 cm with calipers by clinical examination; the exceptions to these criteria are pathologic lymph nodes, which must be >= 1.5 cm in the short axis when assessed by CT scans with slice thickness =< 0.5 cm
  • Non-measurable lesions include the following: small lesions (longest diameter < 1.0 cm for all lesions other than pathologic lymph nodes, which are >= 1.0 cm and < 1.5 cm in the short axis), bone metastases, pleural effusions, pericardial effusions, ascites, inflammatory breast disease, leptomeningeal disease, lymphangitis pulmonis, lymphangitis cutis, and abdominal masses not followed by CT or magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Life expectancy of > 12 weeks
  • Patients with a history of resected brain metastases are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including =< 28 days of study registration
  • Patients who receive stereotactic radiosurgery or whole brain radiation for brain metastases are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including =< 28 days of study registration
  • Obtained =< 7 days prior to registration: Absolute neutrophil count >= 1500/uL
  • Obtained =< 7 days prior to registration: Platelet count >= 100,000/uL
  • Obtained =< 7 days prior to registration: Hemoglobin >= 9 g/dL
  • Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert?s syndrome
  • Obtained =< 7 days prior to registration: Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferases [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN except in the case of liver metastases, where =< 5 x ULN is allowed
  • Obtained =< 7 days prior to registration: Creatinine =< 2.0 mg/dL or creatinine clearance > 50 mL/min
  • Obtained =< 7 days prior to registration: Corrected QT (QTc) interval =< 500 msec on the baseline electrocardiogram
  • Negative pregnancy test done =< 72 hours prior to registration for women of childbearing potential only; Note: all female subjects will be considered to be of child-bearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation >= 1 menstrual cycle prior to randomization, or have undergone a hysterectomy and/or bilateral oophorectomy)
  • Female subjects of child-bearing potential must agree to use highly effective contraception during the study treatment and for 3 months after the final dose of study treatment; female subjects exempt from this requirement are subjects who practice total abstinence; if currently abstinent, the subject must agree to use a double barrier method of contraception (i.e., condom and occlusive cap [diaphragm or cervical/vault caps]) with spermicide or until they are established on highly effective contraception for at least one menstrual cycle if they become sexually active during the study treatment and for 3 months after the final dose of study treatment
  • Highly effective contraception includes:
  • Placement of intrauterine device or system
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault cap) with spermicide
  • Vasectomized partner with confirmed azoospermia
  • Male subjects and their female partner who are of child-bearing potential (as defined above), and are not practicing total abstinence, must agree to use highly effective contraception during study treatment and for 3 months after the final dose of study treatment; if currently abstinent, the subject must agree to use a double barrier method of contraception if they become sexually active, or until they are established on highly effective contraception as described above
  • Ability to complete questionnaire(s) independently or with assistance
  • Willingness to provide blood and tissue samples for correlative research purposes; (Note: these tissue samples are from archived tissue, if available; new biopsies are not required)
  • Ability to comprehend and respond to questions using a telephone keypad

Who cannot join

  • Prior malignancy, other than carcinoma in situ of the cervix and non-melanoma skin cancers, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously, there is no subsequent evidence of recurrence, and the patient is considered by a physician to be at < 30% risk of relapse
  • Any of the following:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Presence of a serious nonhealing wound, ulcer, or bone fracture
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  • History of Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 hypersensitivity to paclitaxel or Cremophor EL
  • Pre-existing peripheral neuropathy grade ?= 2 at registration
  • Significant cardiovascular impairment (e.g., New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia)
  • Subjects with known positive human immunodeficiency virus (HIV) status
  • History of stroke or transient ischemic attack =< 6 months prior to registration
  • History of uncontrolled seizures; (Note: patients are eligible for the study if the seizures are well controlled with standard medications)
  • Severe or uncontrolled intercurrent illness/infection
  • Concurrent administration of any other investigational agent considered to have potential efficacy in the treatment of breast cancer
  • Prior exposure to eribulin mesylate

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Mission Hospital-Saint Joseph Campus

    Asheville, North Carolina, 28801

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Essentia Health NCI Community Oncology Research Program

    Duluth, Minnesota, 55805

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • New Hampshire Oncology Hematology PA-Hooksett

    Hooksett, New Hampshire, 03106

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Ochsner NCI Community Oncology Research Program

    New Orleans, Louisiana, 70121

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Cancer Alliance of Nebraska

    Omaha, Nebraska, 68106

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64507

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Heartland Cancer Research CCOP

    St Louis, Missouri, 63131

  • Carle Cancer Center NCI Community Oncology Research Program

    Urbana, Illinois, 61801

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

This randomized phase III trial studies how well eribulin mesylate or paclitaxel work as first- or second-line therapy in treating patients with stage IIIC-IV breast cancer that has come back. Drugs used in chemotherapy, such as eribulin mesylate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To demonstrate that patient-reported Patient-Report Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) data will be able to detect differences in symptoms between participants treated witheribulin mesylate (eribulin) and standard weekly paclitaxel at 12 weeks.

II. To validate rs7349683 in EPHA5 as a predictor of peripheral neuropathy from treatment with a microtubule targeting agent (i.e., eribulin or paclitaxel).

SECONDARY OBJECTIVES:

  1. To compare overall survival, progression free survival (PFS), objective response rate (ORR), duration of response (DOR), and time to treatment failure (TTF) in patients receiving eribulin versus standard weekly paclitaxel.

II. To compare the 12 month rate of disease progression in patients receiving eribulin versus standard weekly paclitaxel.

III. To evaluate the clinical value and feasibility of collecting patient-reported symptom toxicity information via the Patient-Report Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

IV. To further validate the PRO-CTCAE sensory neuropathy items. V. To compare patient reported neurotoxicity between arms using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) instrument.

VI. To assess the toxicities in patients receiving eribulin versus standard weekly paclitaxel.

CORRELATIVE OBJECTIVES:

  1. To compare new metastasis free survival in patients receiving eribulin versus standard weekly paclitaxel.

II. To explore the relationship between common single nucleotide polymorphisms in FGD4, FZD3, and VAC14 as predictors of peripheral neuropathy from treatment with a microtubule targeting agent (i.e., eribulin or paclitaxel).

III. To evaluate circulating nucleosomes and the apoptosis associated M30 neo-epitope as potential biomarkers associated with clinical benefit from treatment with eribulin specifically or the microtubule dynamics inhibitors in general.

VI. To evaluate tubulin isotype expression, mutations, and signaling pathway modifications in tumor tissue as potential biomarkers associated with clinical benefit from treatment with eribulin specifically or the microtubule dynamics inhibitors in general.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks.

Being tested
Eribulin Mesylate, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Eribulin MesylateDrug

    Also called B1939 Mesylate, E7389, ER-086526, Halaven

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT02037529
Study groupRoleWhat they receive
Arm A (eribulin mesylate)ExperimentalPatients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Eribulin Mesylate; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment
Arm B (paclitaxel)ExperimentalPatients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Quality-of-Life Assessment

What is being measured

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

  1. Cumulative Dose Level Triggering a Grade 2 or Higher Neuropathy Event.

    To validate rs7349683 in EPHA5 as a predictor of peripheral neuropathy from treatment with a microtubule targeting agent (i.e., eribulin or paclitaxel) over the first 6 months of treatment we will compare the median cumulative dose level triggering a grade 2 or higher neuropathy event.

    Measured: 6 months

  2. Mean Change in Patient Reported PRO-CTCAE

    To demonstrate that patient-reported PRO-CTCAE data will be able to detect differences in symptoms between participants treated with eribulin and standard weekly paclitaxel at 12 weeks we will compare the mean change of overall Pro-CTCAE score by treatment arm. The overall Pro-CTCAE score is a normalized score scaled from 20 questions, each with a possible 1-5 patient selection, creating an overall score (0-100) where 0 represents the best outcome and 100 represents the worst possible outcome. The mean change from baseline to week 12 is reported.

    Measured: 12 weeks

Secondary outcomes (9)

  1. Overall Survival (OS)

    The primary analysis will use the stratified log-rank tests, as described for overall survival. As a secondary analysis we will use a multivariable Cox proportional hazard model to estimate adjusted hazard ratios for eribulin mesylate over standard weekly paclitaxel, study stratification factors, and covariates for known prognostic factors, including disease free interval and visceral versus non-visceral metastases. Survival functions will be summarized using the Kaplan-Meier method according to treatment group.

    Measured: 81 months

  2. Objective Tumor Response Rate

    Objective tumor response rate is assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Measured: 64 months

  3. Duration of Response

    Will be summarized using the Kaplan-Meier method. Will use a two-sided type I alpha of 0.05, and point estimates will be reported with 95% confidence intervals. Duration of response is the time between a tumor response and progression.

    Measured: 75 months

  4. Time to Treatment Failure

    Will use a two-sided type I alpha of 0.05, and point estimates will be reported with 95% confidence intervals.

    Measured: 64 months

  5. Incidence of Treatment Related Adverse Events

    The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). Events determined to be possibly or probably attributed to a medical treatment suggest there is evidence to indicate a causal relationship between the drug and the adverse event. The number of patients that experienced an AE, of any grade, determined to be possibly or probably attributed to a medical treatment will be reported by arm.

    Measured: 64 months

  6. Time to New Metastasis

    Will be summarized using the Kaplan-Meier method. Will use a two-sided type I alpha of 0.05, and point estimates will be reported with 95% confidence intervals.

    Measured: 81 months

  7. Progression Free Survival Assessed by RECIST 1.1 Criteria

    Will be summarized using the Kaplan-Meier method. Will use a two-sided type I alpha of 0.05, and point estimates will be reported with 95% confidence intervals. Progression free survival time is the time from date of randomization to the date of first progression or death.

    Measured: 80 months

  8. Patients With Reported Neurotoxicity

    Additional analyses will include the previously described analysis conducted over the first 24 weeks; a comparison of the incidence of patient-reported maximum score >= 3 between arms through 12 and 24 weeks using chi-squared testing for each item; and a comparison of the time to patient-reported score >= 3 between arms using Kaplan-Meier and log-rank analyses. Further, these three endpoints will be compared between patient- and clinician-report overall and within arms using appropriate paired analyses.

    Measured: 24 weeks

  9. Validation of PRO-CTCAE Sensory Neuropathy Item

    The PRO-CTCAE sensory neuropathy items will be further validated by computing Pearson correlations between each item, severity and interference, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20 )sensory scale score at baseline, 12 and 24 weeks.

    Measured: At baseline, 12, and 24 weeks

Timeline

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

  1. First posted16 Jan 2014 (estimated)
  2. Study start17 Jan 2014
  3. Primary completion11 Feb 2021
  4. Study completion31 Oct 2024 (estimated)

Why it stopped: Total enrollment number is being lowered

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02037529
Sponsor's protocol ID
RU011201I
Other IDs
NCI-2016-02048, RU011201I, P30CA015083
Status last verified
Aug 2023
First submitted
14 Jan 2014
Last updated
20 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eribulin Mesylate, Laboratory Biomarker Analysis and Paclitaxel in people with Breast Adenocarcinoma and HER2/Neu Negative, run by Academic and Community Cancer Research United at 39 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 48 inclusion and 15 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: paused, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 6 Sep 2023). 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?

Cumulative Dose Level Triggering a Grade 2 or Higher Neuropathy Event. (time frame: 6 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 NCT02037529.

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 20 Aug 2024.

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