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Breast NeoplasmsPhase 2NCT00620100

To Determine the Objective Response Rate of 4 Cycles of Docetaxel + Anthracycline (Epirubicin or Doxorubicine) Followed by 4 Cycles of Docetaxel Single Agent

A Phase 2 study testing Docetaxel in people with Breast Neoplasms, run by Sanofi at 2 sites in 2 countries.

Terminated

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

Official record
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Trial summary

To determine the Objective Response Rate of 4 cycles of docetaxel + anthracycline (epirubicin or doxorubicine) followed by 4 cycles of docetaxel single agent. To determine the Time to Tumor Progression (TTP), the Response Duration, the Overall Survival. To confirm the safety profile Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Docetaxel
How many people
2 participants
Where
2 sitesin 2 countries
Study dates
Sep 2004to Apr 2005
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patient with histologically or cytologically documented breast adenocarcinoma
  • First local or metastatic relapse
  • Patients must have received a prior neoadjuvant or adjuvant Taxotere®-based chemotherapy regimen, provided this chemotherapy was completed > than or = to 12 months prior to enrollment date
  • Prior hormone or immune therapy is allowed. Antitumoral adjuvant hormone therapy may be continued during the study period, provided it was started > 12 months prior to study enrollment
  • Her2/neu negative tumor demonstrated by immunohistochemistry (IHC 0 or 1+) or by fluorescence in situ hybridation (FISH -). A patient with tumor assessed as 2+ by IHC can be enrolled if the tumor is negative by FISH.
  • ECOG performance status of 0 to 2
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  • Normal cardiac function confirmed by LVEF or shortening fraction (MUGA scan or echocardiography, respectively, within normal limits for the institution) assessed within 3 months prior to study entry. An ECG must be obtained within 4 weeks prior study entry and must demonstrate no clinically significant abnormality.
  • Patients are required to have at least one measurable lesion according to RECIST guidelines
  • Adequate organ function defined by:
  • Hematology: Neutrophils > than or = to 2.0 109/L, Platelets > than or = to 100 109/L, Hemoglobin > than or = to 10 g/dL
  • Hepatic function: Total bilirubin within normal limits, AST (SGOT) and ALT (SGPT) < than or = to 1.5 UNL, alkaline phosphatase < than or = to 2.5 UNL (unless accompanied by extensive bone metastases)
  • Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential
  • Written informed consent prior to beginning specific protocol procedures must be obtained and documented according to the local regulatory requirements

Who cannot join

  • Prior therapy for advanced or recurrent disease
  • Previous cumulative exposure to epirubicin > 600 mg/m² or to doxorubicin > 300 mg/m²
  • Previous radiation therapy having involved more than 25% of bone marrow; incomplete recovery from toxicity of radiation therapy
  • Symptomatic brain metastases and clinically diagnosed leptomeningeal metastases
  • Isolated unmeasurable bone lesions, serous pleural effusion or pulmonary lymphangiitis (i.e., unmeasurable disease according to the RECIST guidelines)
  • Pre-existing motor or sensory neurologic toxicity of a severity > than or = to grade 2 according to NCI-CTC AE criteria version 3.0
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  • Pregnant or lactating women or women of childbearing potential not using adequate contraception
  • Other serious illness or medical conditions, including:
  • Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
  • History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would hamper understanding and giving informed consent.
  • Active uncontrolled infection
  • Active peptic ulcer, uncontrolled diabetes mellitus
  • Past or current history of neoplasm other than breast carcinoma, except:
  • Curatively treated non-melanoma skin cancer.
  • in situ carcinoma of the cervix.
  • Other cancer curatively treated and with no evidence of disease for at least 10 years
  • Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< than or = to 20 mg methylprednisolone per day or equivalent)
  • Definite contraindications for the use of corticosteroids
  • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)
  • Concurrent treatment with other investigational drugs. Active treatment as part of another clinical therapeutic trial within 30 days prior to study entry
  • Concurrent treatment with any other anti-cancer therapy, except adjuvant hormone therapy started > than or = to 12 months prior to study enrollment. Bisphosphonates for management of bone metastases or osteoporosis/osteopenia are allowed
  • History of hypersensitivity to docetaxel (or drugs formulated in polysorbate 80), epirubicin or doxorubicin
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  • Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

  • Sanofi-Aventis

    Vienna

Other trials in Austria

Poland1 site

  • Sanofi-aventis

    Warsaw

Other trials in Poland

About this study

Official title: A Multicenter, Open Label, Phase II Trial Evaluating Docetaxel (Taxotere®) + Anthracycline (Epirubicin or Doxorubicin) x 4 Cycles Followed by Docetaxel (T) Single Agent x 4 Cycles as First-Line Therapy in Patients With Her2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Relapsed > or = 12 Months From Completion of Neoadjuvant/Adjuvant Taxotere®-Based Chemotherapy

To determine the Objective Response Rate of 4 cycles of docetaxel + anthracycline (epirubicin or doxorubicine) followed by 4 cycles of docetaxel single agent. To determine the Time to Tumor Progression (TTP), the Response Duration, the Overall Survival. To confirm the safety profile

Being tested
Docetaxel
Medical subject headings
Breast Neoplasms

What participants receive

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

What is being measured

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

  1. Evaluate the objective response rate according to RECIST guidelines after treatment with Taxoterer and anthracycline followed by Taxoterer single agent in the first line treatment of Her2 negative locally advanced or metastatic breast cancer

    Measured: During the study conduct

Secondary outcomes (4)

  1. To evaluate the Time to Tumor Progression (TTP).

    Measured: During the study conduct

  2. To evaluate the response duration.

    Measured: During all the study conduct

  3. To evaluate the overall survival.

    Measured: During the study conduct

  4. To confirm the safety profile.

    Measured: from the inform consent signed up to the end of the study

Timeline

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

  1. First posted21 Feb 2008 (estimated)
  2. Study startSep 2004
  3. Primary completionApr 2005
  4. Study completionApr 2005

Why it stopped: the study was early terminated due to lack of recruitment.

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00620100
Sponsor's protocol ID
XRP6976A_2504
Status last verified
May 2009
First submitted
11 Feb 2008
Last updated
3 Jun 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel in people with Breast Neoplasms, run by Sanofi at 2 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 13 inclusion and 25 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 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria, 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 was stopped early (reason given: the study was early terminated due to lack of 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?

Evaluate the objective response rate according to RECIST guidelines after treatment with Taxoterer and anthracycline followed by Taxoterer single agent in the first line treatment of Her2 negative locally advanced or metastatic breast cancer (time frame: During the study conduct). 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 NCT00620100.

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 3 Jun 2009.

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