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Individualized ChemotherapyPhase 2NCT00425516

Breast Cancer Treated by Neoadjuvant Chemotherapy

A Phase 2 study testing Taxotere, 5-Fluorouracil and Epirubicin in people with Individualized Chemotherapy, run by Centre Jean Perrin at 6 sites in France.

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

Neoadjuvant chemotherapy, known as "first" or "induction chemotherapy" in the therapeutic assumption of breast cancer is based on the narrow dependence preclinically revealed between primary tumour, tumoral angiogenesis and growth of distant metastases. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Individualized Chemotherapy
What is being tested?
Taxotere, 5-Fluorouracil and Epirubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
6 sitesFrance
Study dates
Jan 2007to Aug 2014
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with histological proof of non metastatic breast cancer, whose clinical tumor diameter is > 2 cm, or < 2 cm, but situated in areolar area of the nipple.
  • T2-T3, N0-N1 tumor, non-inflammatory, unilateral, non-metastatic, grade II - III, HER2-neu negative, without extension beyond the breast and axillar area.
  • Performance Status = 0-1 WHO.
  • Patient non pretreated for breast cancer.
  • Patient without cardiac pathology and without anthracyclines contra-indication (assessed by normal ejection fraction).
  • Normal haematological, renal and hepatic functions : PNN > 2.109 /l, platelets > 100. 109 /l, Hb > 10 g/dl, normal bilirubin serum , ASAT and ALAT < 2,5 ULN, alkaline phosphatases < 2,5 ULN, creatinin < 140 µmol/l or creatinin clearance > 60 ml/min
  • Written informed consent dated and signed by the patient

Who cannot join

  • All other breast cancers than those described in inclusion criteria, in particular inflammatory and/or neglected (T4b or T4d) forms.
  • Patient presenting with plurifocal tumors, multicentric tumor, bilateral tumor.
  • Grade I well differentiated tumor.
  • HER2 neu 3 + (ICH or FISH or CISH) tumor.
  • Non measurable lesion, in the two diameters, whatever radiological methods used.
  • Patient presenting microcalcifications for which breast conservation is not possible.
Show all 13Show fewer
  • Patient already operated for breast cancer or having had primary axillar node dissection.
  • Patient having antecedent of other cancer, exception for in situ uterine cervix or basocellular skin cancer, considered as healed.
  • Patient presenting another pathology considered as incompatible with patient inclusion in the study
  • Patient should not receive treatment with any other investigational drug and should not participate to another clinical study in a delay < 30 days or should not be pre-treated by cytostatic chemotherapy.
  • Antecedents of allergy to polysorbate 80.
  • Patient who is pregnant or lactating and not using effective contraceptive method.
  • Any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow up schedule, assessed with the patient prior to registration in the trial

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Hospital center

    Brive-la-Gaillarde, 19100

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • University Hospital La Tronche

    Grenoble, 38043

  • Edouard Herriot University Hospital

    Lyon, 69000

  • Institut Jean Godinot

    Reims, 51056

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42270

Other trials in France

About this study

Official title: Clinical Trial of the Neoadjuvant Standard Chemotherapy 3 FEC 100 + 3 TAXOTERE Protocol Versus the Same Protocol Adapted as a Function of Clinical Response

Neoadjuvant chemotherapy, known as "first" or "induction chemotherapy" in the therapeutic assumption of breast cancer is based on the narrow dependence preclinically revealed between primary tumour, tumoral angiogenesis and growth of distant metastases.

The results of the Aberdeen Group (Smith et al, 2002 ; Hutcheon et al, 2003), of the NSABP B27 trial (Bear et al, 2003) and of the Gepar-Duo Group (Von Minckwitz et al, 2002) have shown that a sequential protocol, using docetaxel after an anthracycline-based combination, allowed a better clinical response leading to more frequent conservative surgeries and, more importantly, to an increase in the rate of complete pathological response, assessing a better efficacy.

Read more

The use of a reference adjuvant protocol as a neo-adjuvant treatment is fully admissible because 7 randomized trials have shown a perfect equivalence between an adjuvant protocol and the same chemotherapy given as an induction treatment Even keeping the principle of a sequential treatment, a crucial question is to know if this sequential treatment should be the same for all patients, or if the oncologist could get a better complete pathological response, disease-free or overall survival rates by an adaptation of treatment to the objective result beginning after 2 FEC 100 courses by modulation of the following courses.

We will use as a primary regimen 3 FEC cycles + 3 TAXOTERE cycles, a standard adjuvant regimen (noted in the Temporary Protocol of Treatment of the Inca page 5 (October 2005) as well as in Saint Paul de Vence 2005 recommendations for adjuvant chemotherapy (Oncologie -- volume 7 - N°5, August 2005, p 370). This standard treatment will be compared to the same chemotherapy modulated in its repartition according to results obtained by subsequent tumor evaluations during induction therapy.

Keywords
neoadjuvant chemotherapy, breast cancer, sequential treatment
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT00425516
Study groupRoleWhat they receive
standard (A)No intervention3 FEC100 followed 3 Taxotere
Modulated (B)Experimentalpossibility treatments receive: 2 FEC100 followed by 4 Taxotere 4 FEC100 followed by 2 Taxotere 6 FEC 100
Receives: Drug: Taxotere; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide

What is being measured

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

  1. Improvement of complete pathological response rate at surgery after 6 chemotherapy cycles

    Measured: after 6 cycles of chemotherapy

Secondary outcomes (5)

  1. Tolerance according to NCI-CTC criteria

    Measured: after each cycle of chemotherapy

  2. Objective clinical, echographic, mammographic responses after 6 cycles

    Measured: after every 2 cycles of chemotherapy treatment

  3. Breast conservation rate

    Measured: at surgery

  4. Study of biological predictive factors of chemosensitivity and resistance by immunological and molecular biology techniques)

    Measured: before receive chemotherapy

  5. Overall and relapse-free survivals

    Measured: 5 years after diagnosis

Timeline

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

  1. First posted23 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionAug 2014
  4. Study completionAug 2014

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
None (open label)
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00425516
Sponsor's protocol ID
CJP AU651/Afssaps060744
Status last verified
Feb 2007
First submitted
22 Jan 2007
Last updated
1 Oct 2014
Results posted
No

Publications

  • Roché H, Fumoleau P, Spielman M et al. Breast Cancer Res Treat. 2004;88(suppl1):S16. Abstract 27

  • Mouret-Reynier MA, Abrial CJ, Ferriere JP, Amat S, Cure HD, Kwiatkowski FG, Feillel VA, Lebouedec G, Penault-Llorca FM, Chollet PJ. Neoadjuvant FEC 100 for operable breast cancer: eight-year experience at Centre Jean Perrin. Clin Breast Cancer. 2004 Oct;5(4):303-7. doi: 10.3816/cbc.2004.n.035.

    PubMed 15507178

  • Wang-Lopez Q, Mouret-Reynier MA, Savoye AM, Abrial C, Kwiatkowski F, Garbar C, DuBray-Longeras P, Eymard JC, Lebouedec G, Vanpraagh I, Penault-Llorca F, Chollet P, Cure H. Is it important to adapt neoadjuvant chemotherapy to the visible clinical response? An open randomized phase II study comparing response-guided and standard treatments in HER2-negative operable breast cancer. Oncologist. 2015 Mar;20(3):243-4. doi: 10.1634/theoncologist.2014-0400. Epub 2015 Jan 30.

    PubMed 25637380

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Taxotere, 5-Fluorouracil and Epirubicin in people with Individualized Chemotherapy, run by Centre Jean Perrin at 6 sites in France.

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 7 inclusion and 13 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 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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?

Improvement of complete pathological response rate at surgery after 6 chemotherapy cycles (time frame: after 6 cycles of chemotherapy). 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 NCT00425516, which also lists 3 linked publications.

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 1 Oct 2014.

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