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Breast CancerPhase 2NCT02120417

A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer

A Phase 2 study testing Ruxolitinib and Capecitabine in people with Breast Cancer, run by Incyte Corporation at 106 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine alone. 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?
Ruxolitinib and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
149 participants
Where
106 sitesin 6 countries
Study dates
May 2014to Jan 2017
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

  • Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
  • Locally advanced (Stage 3B) or metastatic (Stage 4) disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
  • Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
  • ≥ 2 weeks elapsed from the completion of previous treatment regimen and must have recovered or be at a new stable baseline from any related toxicities
Show all 11Show fewer
  • Radiographically measurable or evaluable disease
  • An mGPS of 1 or 2 as defined below:
  • Criteria:
  • modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
  • mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L

Who cannot join

  • Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
  • Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
  • Unknown hormone-receptor status
  • Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
  • Concurrent anticancer therapy
  • Inadequate renal, hepatic or bone marrow function
  • Another current or previous malignancy within 2 years of study entry unless approved by the sponsor

Trial locations and contacts

106 sites in 6 countries.

106 sites in 6 countries

United States80 sites

  • Study site

    Albany, New York

  • Study site

    Ames, Iowa

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bedford, Texas

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Birmingham, Alabama

  • Study site

    Camden, New Jersey

  • Study site

    Canton, Ohio

  • Study site

    Chandler, Arizona

  • Study site

    Charleston, South Carolina

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Duluth, Minnesota

  • Study site

    El Paso, Texas

  • Study site

    Fairfax, Virginia

  • Study site

    Farmington, New Mexico

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Germantown, Tennessee

  • Study site

    Goldsboro, North Carolina

  • Study site

    Grand Island, Nebraska

  • Study site

    Green Bay, Wisconsin

  • Study site

    Greenville, South Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Hialeah, Florida

  • Study site

    Houston, Texas

  • Study site

    Johnson City, New York

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kansas City, Missouri

  • Study site

    La Jolla, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Marietta, Georgia

  • Study site

    McAllen, Texas

  • Study site

    Miami, Florida

  • Study site

    Middletown, Ohio

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Ogden, Utah

  • Study site

    Omaha, Nebraska

  • Study site

    Oxnard, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pinehurst, North Carolina

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Plantation, Florida

  • Study site

    Portland, Oregon

  • Study site

    Quincy, Illinois

  • Study site

    Richmond, Virginia

  • Study site

    Salem, Virginia

  • Study site

    Salt Lake City, Utah

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Santa Monica, California

  • Study site

    Savannah, Georgia

  • Study site

    Seattle, Washington

  • Study site

    Sedona, Arizona

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Tampa, Florida

  • Study site

    The Bronx, New York

  • Study site

    Tyler, Texas

  • Study site

    Urbana, Illinois

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wichita, Kansas

Other trials in United States

Italy9 sites

  • Study site

    Alba

  • Study site

    Fano

  • Study site

    Foggia

  • Study site

    Lecco

  • Study site

    Milan

  • Study site

    Naples

  • Study site

    Pontedera

  • Study site

    Roma

  • Study site

    Saronno

Other trials in Italy

United Kingdom9 sites

  • Study site

    Cardiff

  • Study site

    Glasgow

  • Study site

    Kingston upon Thames

  • Study site

    London

  • Study site

    Nottingham

  • Study site

    Sutton

  • Study site

    Taunton

  • Study site

    Truro

  • Study site

    Yeovil

Other trials in United Kingdom

Spain5 sites

  • Study site

    A Coruña

  • Study site

    Barcelona

  • Study site

    Jaén

  • Study site

    Lleida

  • Study site

    Madrid

Other trials in Spain

France2 sites

  • Study site

    La Roche-sur-Yon

  • Study site

    Paris

Other trials in France

Portugal1 site

  • Study site

    Lisbon

Other trials in Portugal

About this study

Official title: A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer

This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine alone.

Conditions
Breast Cancer
Being tested
Ruxolitinib, Capecitabine, Placebo
Keywords
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.

  • RuxolitinibDrug

    Also called Jakafi ®, Jakavi ®

    5 mg tablets to be administered by mouth

    Ruxolitinib 15 mg BID (starting dose)

  • CapecitabineDrug

    Capecitabine 2000 mg/m^2 daily given as 1000 mg/m^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle

  • PlaceboDrug

    5 mg matching placebo tablets to be administered by mouth

Study groups in NCT02120417
Study groupRoleWhat they receive
Treatment A - Capecitabine and ruxolitinibExperimentalNot described
Receives: Drug: Ruxolitinib; Drug: Capecitabine
Treatment B - Capecitabine and placeboActive comparatorNot described
Receives: Drug: Capecitabine; Drug: Placebo

What is being measured

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

  1. Overall Survival (OS)

    Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.

    Measured: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.

  2. Median Survival

    Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.

    Measured: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.

  3. Percentage of Participants Achieving Overall Survival

    Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.

    Measured: Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.

    Measured: Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.

  2. Percentage of Participants Achieving Objective Response Rate

    Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.

    Measured: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.

  3. Duration of Response (DOR)

    The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement. The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria. The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria. The date of progressive disease was the date on which progression was first recorded. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.

    Measured: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.

  4. Percentage of Participants Achieving Clinical Benefit Rate

    Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.

    Measured: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.

Timeline

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

  1. First posted22 Apr 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionFeb 2016
  4. Study completionJan 2017

Why it stopped: The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation.

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02120417
Sponsor's protocol ID
INCB 18424-268
Status last verified
Jan 2018
First submitted
18 Apr 2014
Last updated
13 Feb 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib and Capecitabine in people with Breast Cancer, run by Incyte Corporation at 106 sites in 6 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 11 inclusion and 7 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 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Italy, United Kingdom, Spain, France and 1 more country. 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 12 Jul 2017). 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?

Overall Survival (OS) (time frame: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.). The study lists 3 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 NCT02120417.

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 13 Feb 2018.

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