Breast CancerPhase 2NCT01301040

Early Cardiac Toxicity of Adjuvant CT in Elderly BC.

A Phase 2 study testing epirubicin, cyclophosphamide, docetaxel in people with Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.

Terminated

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

Official record

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Trial summary

The primary objective is to evaluate the difference in cardiac strain rate evolution in elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy compared with a non-anthracycline regimen (Taxotere-cyclophosphamide) CT. Read more about this study

Who is it for?: Ages 65 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: epirubicin, cyclophosphamide, docetaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteBelgium
Study dates: Mar 2011to Mar 2016
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 65 years and older
Women only
No healthy volunteers
Older adult

Patient selection criteria

Female aged equal or more than 65 years.
Histological diagnosis of early BC for which the treating physician considers (neo) adjuvant chemotherapy to be beneficial. Recommended situations are:
Triple negative BC if pT > 1cm.
HER-2 positive BC if pT1 > 1cm; and trastuzumab will be given after study chemotherapy.
"Luminal B" cancers defined as ER+, PgR + or neg, Ki-67 ≥ 14%, and pT1 > 1cm.
"Luminal A" cancers (ER+, PgR+ and Ki-67 < 14%) will be considered only if ≥ 4 nodes.
Poor response to a preoperative endocrine therapy.
WHO performance status equal or less than 1.
Baseline LVEF equal or more than 50% measured by echocardiography.
Adequate organ function including:
neutrophils more or equal to 1.5 x 109/L.
platelets more or equal to100 x 109/L.
bilirubin < 1.25 x upper limit of normal (ULN) for the institution.
transaminases: AST < 2.5 x ULN , ALT < 2.5 x ULN and alkaline phosphatase ≤ 2.5 x ULN for the institution.
Estimated creatinine clearance > 30ml/min (using the Crockoft and Gault formula) (See Appendix E) .
No previous exposure to chemotherapy in this neoadjuvant or adjuvant setting.
No serious cardiac illness or medical conditions as judged by the investigator including, but not confined to:Symptomatic ventricular arrhythmias,Clinical and/or ECG evidence of myocardial infarction within the last 12 months,Coronary artery disease requiring medication,High-risk uncontrolled arrhythmias,Poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg).
Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness.
No participation to other clinical trials involving therapeutic agents within the 6 weeks prior to the randomization.
No prior or concurrent diagnosis of cancer, except for adequately treated basocellular and squamous cell carcinoma of the skin or cervical uterine in situ tumor
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Signed written informed consent must be given according to ICH-GCP and national/local regulations, prior to any study specific screening procedures and randomization.

Caregiver selection criteria

to be identified by participating patients as their primary caregivers i.e the person who helps them the most to cope with cancer in their everyday life
to be at least eighteen years old
to be aware of the cancer diagnosis of the patients to be fit enough to complete the questionnaires
to be French speaking
to be free of any cognitive dysfunction.
to give their written informed consent as regards participation in the study.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Institut Jules Bordet
Brussels, 1000

Other trials in Belgium

About this study

Official title: Early Detection of Chemotherapy Induced Cardiac Damage in Elderly Patients With Early Breast Cancer: a Randomized Phase II Trial Comparing (Neo) Adjuvant Epirubicin-cyclophosphamide (EC) Versus Docetaxel (Taxotere)-Cyclophosphamide (TC.)

This study also will compare the serum biomarkers profile during and after the (neo) adjuvant CT in both treatment arms, assess whether MRI allows detecting earlier than standard echocardiography the signs of cardiotoxicity, during and after adjuvant (neo) CT, assess whether brain PET-CT allows detecting regional functional impairment in patients receiving CT, evaluate cognitive function before and after (neo) adjuvant CT in both treatment arms, evaluate distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate psychological state and burden of primary caregivers before and after (neo) adjuvant CT in both treatment arms, evaluate primary caregivers abilities to detect patients' distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate the short and long-term toxicity profile of the regimens, estimate the 10-year risk of relapse and/or death using the Adjuvant!Online tool, and estimate the Framingham risk score for Hard Coronary Heart Disease (10-year risk).

Read the detailed description

Considering that both anthracycline-based and Taxotere-cyclophosphamide CT have established efficacy in the adjuvant treatment of elderly patients with early breast cancer, and the paucity of data for early cardiac toxicities with anthracycline-based adjuvant therapy compared to non-anthracycline regimen, this is the first randomized study to evaluate early cardiac signs based on doppler myocardial imaging (DMI). The results of this study could improve the monitoring of the cardiac function of elderly patients candidates to receive adjuvant chemotherapy for early breast cancer.

Conditions: Breast Cancer
Being tested: epirubicin, cyclophosphamide, docetaxel
Keywords: breast cancer, elderly, early cardiac toxicity
Medical subject headings: Breast Neoplasms, Cardiotoxicity

What participants receive

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

epirubicin, cyclophosphamide, docetaxelDrug
Also called Docetaxel: Taxotere, Cyclophosphamide: Endoxan, Epirubicin: Epirubicin Teva
- Treatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.
- Treatment Arm 2: TC - docetaxel (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.

Study groups in NCT01301040
Study group	Role	What they receive
Epirubicin/Cyclophosphamide	Active comparator	Treatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles Receives: Drug: epirubicin, cyclophosphamide, docetaxel
docetaxel/cyclophosphamide	Active comparator	Treatment Arm 2: TC - docetaxel (Taxotere) (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles. Receives: Drug: epirubicin, cyclophosphamide, docetaxel

What is being measured

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

The difference between cardiac strain rates measured at baseline and after 4 cycles of chemotherapy.
The primary null hypothesis is that the means are equal versus the alternative hypothesis that the means are different. We plan to perform the comparison using a two-sided Student's t-test with α=5%. The power of the study to detect the difference described below has been set at 90%.
One hundred twenty patients candidate to receive neoadjuvant or adjuvant CT for early BC will be randomized 1:1 to receive either epirubicin-cyclophosphamide (EC) or docetaxel (Taxotere) -cyclophosphamide (TC) for 4 cycles.
Measured: Before chemotherapy, after chemotherapy, at 6 months, one , two and 3 years from randomization.

Timeline

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

Mar 2011Mar 2016

First posted23 Feb 2011 (estimated)
Study startMar 2011
Primary completionMar 2013
Study completionMar 2016 (estimated)

Why it stopped: Slow recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01301040
Sponsor's protocol ID: IJB 11-01
Other IDs: 2011-000562-35
Status last verified: Feb 2011
First submitted: 18 Feb 2011
Last updated: 30 Aug 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Detection of Chemotherapy Induced Cardiac Damage in Elderly Patients With Early Breast Cancer: a Randomized Phase II Trial Comparing (Neo) Adjuvant Epirubicin-cyclophosphamide (EC) Versus Docetaxel (Taxotere)-Cyclophosphamide (TC.)
ClinicalTrials.gov ID: NCT01301040
Acronym / sponsor ID: IJB 11-01
Conditions: Breast Cancer
Keywords: breast cancer, elderly, early cardiac toxicity
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow recruitment
Enrolment: 2 participants (actual)
Lead sponsor: Jules Bordet InstituteUniversity, hospital or other
Collaborators: Sanofi
Study start: Mar 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2016 (estimated)
First posted: 23 Feb 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Epirubicin/Cyclophosphamide	Active comparator	Drug: epirubicin, cyclophosphamide, docetaxelTreatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles
docetaxel/cyclophosphamide	Active comparator	Drug: epirubicin, cyclophosphamide, docetaxelTreatment Arm 2: TC - docetaxel (Taxotere) (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.

Who may qualify

Ages: 65 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
epirubicin, cyclophosphamide, docetaxelAlso: Docetaxel: Taxotere, Cyclophosphamide: Endoxan, Epirubicin: Epirubicin Teva* Treatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles. * Treatment Arm 2: TC - docetaxel (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.	Drug	Epirubicin/Cyclophosphamide, docetaxel/cyclophosphamide

Primary outcome

The difference between cardiac strain rates measured at baseline and after 4 cycles of chemotherapy.
Time frame: Before chemotherapy, after chemotherapy, at 6 months, one , two and 3 years from randomization.
The primary null hypothesis is that the means are equal versus the alternative hypothesis that the means are different. We plan to perform the comparison using a two-sided Student's t-test with α=5%. The power of the study to detect the difference described below has been set at 90%. One hundred twenty patients candidate to receive neoadjuvant or adjuvant CT for early BC will be randomized 1:1 to receive either epirubicin-cyclophosphamide (EC) or docetaxel (Taxotere) -cyclophosphamide (TC) for 4 cycles.

Results and safety

The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.

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Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lissandra Dal Lago, MD principal investigator

Jules Bordet Institute

Evandro De Azambuja, MD principal investigator

Jules Bordet Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing epirubicin, cyclophosphamide, docetaxel in people with Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.

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?

The difference between cardiac strain rates measured at baseline and after 4 cycles of chemotherapy. (time frame: Before chemotherapy, after chemotherapy, at 6 months, one , two and 3 years from randomization.). 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 NCT01301040.

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 30 Aug 2013.