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Breast NeoplasmsPhase 2NCT00580112

An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer

A Phase 2 study testing Dexamethasone and Trabectedin in people with Breast Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 33 sites in 4 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic ( spread of a cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal tissue that grows and spreads in the body… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
Dexamethasone and Trabectedin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
33 sitesin 4 countries
Study dates
Jun 2007to Aug 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with histologically proven diagnosis of progressive metastatic breast cancer
  • Participants with measurable disease as per the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines
  • Participants with bone metastases currently receiving bisphosphonates for palliation will be eligible if other sites of measurable disease are present
  • Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 and adequately recovered from the acute toxicity of any prior treatment
  • Participants with serum creatinine less than or equal to 1.5 milligram per deciliter (mg/dl) or creatinine clearance greater than or equal to 30 milliliter per minute (ml/min)

Who cannot join

  • Participants with previous exposure to trabectedin
  • Participants with more than 3 previous chemotherapy regimens for metastatic disease and known hypersensitivity to components of trabectedin intravenous formulation or dexamethasone
  • Pregnant or lactating women or any women of childbearing potential who is not employing adequate contraception
  • Completion of previous therapy : Less than 2 weeks from radiation therapy or last dose of hormonal therapy, less than 3 weeks from previous biological therapy or chemotherapy
  • Participants with known leptomeningeal disease and other serious illnesses like congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrolment; uncontrolled arterial hypertension or arrhythmias or active infection or psychiatric disorder or active viral hepatitis

Trial locations and contacts

33 sites in 4 countries.

33 sites in 4 countries

United States21 sites

  • Study site

    Amsterdam, New York

  • Study site

    Bedford, Texas

  • Study site

    Columbia, Missouri

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Kansas City, Missouri

  • Study site

    Minneapolis, Minnesota

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Salem, Virginia

  • Study site

    San Antonio, Texas

  • Study site

    Seattle, Washington

  • Study site

    Sedona, Arizona

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Torrington, Connecticut

  • Study site

    Tyler, Texas

  • Study site

    Westminster, Maryland

  • Study site

    Yakima, Washington

Other trials in United States

France5 sites

  • Study site

    Bourdeaux

  • Study site

    Marseille

  • Study site

    Saint-Herblain

  • Study site

    Strasbourg

  • Study site

    Villejuif

Other trials in France

Israel4 sites

  • Study site

    Jerusalem

  • Study site

    Rehovot

  • Study site

    Tel Aviv

  • Study site

    Tel HaShomer

Other trials in Israel

Poland3 sites

  • Study site

    Lubin

  • Study site

    Rybnik

  • Study site

    Szczecin

Other trials in Poland

About this study

Official title: Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers

The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic ( spread of a cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal tissue that grows and spreads in the body until it kills) participants.

Read the detailed description

This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center (when more than 1 hospital or medical school team work on a medical research study) study evaluating the effectiveness and safety of trabectedin in 3 subpopulations of breast cancer participants: Group A: triple negative profile for estrogen receptor, progesterone receptor and human estrogen receptor, Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+) and Group C: familial breast cancer gene 1 (BRCA1) or breast cancer gene 2 (BRCA2) mutation carrier. Participants will receive trabectedin 1.3 milligram per square meter (mg/m^2) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over 3-hour every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Efficacy will be primarily evaluated by percentage of participants with confirmed objective response by independent external review and Investigators assessment. Participants' safety will be monitored throughout the study.

Being tested
Dexamethasone, Trabectedin
Keywords
Breast Neoplasms, Trabectedin, Yondelis
Medical subject headings
Breast Neoplasms

What participants receive

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

  • DexamethasoneDrug

    Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.

  • TrabectedinDrug

    Also called Yondelis

    Trabectedin 1.3 mg/m^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.

Study groups in NCT00580112
Study groupRoleWhat they receive
Group AExperimentalParticipants with triple negative phenotype: estrogen receptor, progesterone receptor and human estrogen receptor-2 (HER-2) negative status for breast cancer (abnormal tissue that grows and spreads in the body until it kills) will receive trabectedin 1.3 milligram per meter square (mg/m^2) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over 3-hours (hrs) every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Along with study drug participants will be given dexamethasone 4 milligram (mg) orally 24 hrs and 12hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72hrs after the start of study drug infusion from Day 1 to 3.
Receives: Drug: Dexamethasone; Drug: Trabectedin
Group BExperimentalParticipants with overexpressing HER-2 breast cancer will receive trabectedin 1.3 mg/m^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Along with study drug participants will be given dexamethasone 4 milligram (mg) orally 24 hrs and 12hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion from Day 1 to 3.
Receives: Drug: Dexamethasone; Drug: Trabectedin
Group CExperimentalParticipants with familial breast cancer gene 1 (BRCA1) or breast cancer gene 2 (BRCA2) mutation carriers cancer will receive trabectedin 1.3 mg/m^2 intravenous infusion over 3-hrs every 3 weeks on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Along with study drug participants will be given dexamethasone 4 mg orally 24 hrs and 12hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion from Day 1 to 3.
Receives: Drug: Dexamethasone; Drug: Trabectedin

What is being measured

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

  1. Percentage of Participants With Confirmed Objective Response (OR) by Independent External Review (IER)

    Percentage of participants with confirmed objective response will be based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR is defined as disappearance of all target lesions. PR is those with at least 30 percent decrease in the sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. IER will be done to re-examine all Investigator assessed outcomes.

    Measured: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)

  2. Percentage of Participants With Confirmed Objective Response (OR) by Investigators' Assessment

    Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. The CR is defined as disappearance of all target lesions. The PR is those with at least 30 percent decrease in the sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.

    Measured: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)

Secondary outcomes (6)

  1. Duration of Response (DR) by Independent Expert Review (IER)

    Duration of Response is considered as time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as: (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that will be subsequently confirmed plus 1) divided by 30.44. DR will be calculated for the subgroup of participants with a confirmed objective tumor response. IER will be done to re-examine all Investigator assessed outcomes and to provide an independent assessment of response and progression date.

    Measured: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)

  2. Duration of Response (DR) by Investigators' Assessment

    Duration of Response is considered as time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response is calculated as: (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that will be subsequently confirmed plus 1) divided by 30.44. The DR will be calculated for the subgroup of participants with a confirmed objective tumor response.

    Measured: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)

  3. Progression-Free Survival (PFS) by Independent Expert Review (IER)

    PFS is defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS is calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression will be determined from radiological image (where data meet the criteria for progressive disease [PD]). IER will be done to re-examine all Investigator assessed outcomes and to provide an independent assessment of response and progression date.

    Measured: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)

  4. Progression-Free Survival (PFS) by Investigators' Assessment

    PFS is defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS is calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression will be determined from radiological image (where data meet the criteria for progressive disease [PD]). IER will be done to re-examine all Investigator assessed outcomes and to provide an independent assessment of response and progression date.

    Measured: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)

  5. Number of Participants With Changes in Tumor Volume

    Three dimensional analysis will be used to measure changes in tumor volume.

    Measured: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)

  6. Number of Participants With Changes in Tumoral Radiological Density

    Three dimensional analysis will be used to measure changes in tumoral radiological density.

    Measured: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)

Timeline

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

  1. First posted24 Dec 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionAug 2011
  4. Study completionAug 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00580112
Sponsor's protocol ID
CR014764
Other IDs
ET-B-027-06
Status last verified
Feb 2014
First submitted
20 Dec 2007
Last updated
25 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • Delaloge S, Wolp-Diniz R, Byrski T, Blum JL, Goncalves A, Campone M, Lardelli P, Kahatt C, Nieto A, Cullell-Young M, Lubinski J. Activity of trabectedin in germline BRCA1/2-mutated metastatic breast cancer: results of an international first-in-class phase II study. Ann Oncol. 2014 Jun;25(6):1152-8. doi: 10.1093/annonc/mdu134. Epub 2014 Apr 1.

    PubMed 24692579

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone and Trabectedin in people with Breast Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 33 sites in 4 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 5 inclusion and 5 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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, France, Israel, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants With Confirmed Objective Response (OR) by Independent External Review (IER) (time frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)). 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 NCT00580112, 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 25 Feb 2014.

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