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To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer

25. juli 2016 opdateret af: Hoffmann-La Roche

An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in Females Presenting With Operable Breast Cancer

This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. The participants will receive 4 cycles of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin + Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85). After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast surgery with regional lymph node dissection will be performed, followed within a maximum of 6 weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period, participants will enter the post-treatment follow-up period which will last for 5 years from the initial date of participant randomization. During this period participants will be evaluated once a year on the anniversary date of randomization.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

182

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Bayonne, Frankrig, 64100
      • Beziers, Frankrig, 34500
      • Bourg En Bresse, Frankrig, 01012
      • Colmar, Frankrig, 68024
      • Dijon, Frankrig, 21079
      • Hyeres, Frankrig, 83400
      • La Tronche, Frankrig, 38700
      • Le Mans, Frankrig, 72037
      • Limoges, Frankrig, 87042
      • Lyon, Frankrig, 69437
      • Marseille, Frankrig, 13385
      • Montbeliard, Frankrig, 25209
      • Montfermeil, Frankrig, 93370
      • Nice, Frankrig, 06189
      • Nimes, Frankrig, 30029
      • Paris, Frankrig, 75181
      • Pierre Benite, Frankrig, 69310
      • Saint Herblain, Frankrig, 44805
      • Strasbourg, Frankrig, 67010
      • Toulouse, Frankrig, 31059
      • Vannes, Frankrig, 56001

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Females with a unilateral, non-inflammatory, non-multicentric, non-metastatic breast adenocarcinoma, not considered candidates for conservative management, and whose diagnosis had been histologically confirmed as T2-3, N0-1, M0 according to the tumor-nodes-metastasis (TNM) classification
  • Clinically or radiologically measurable lesion (in 2 dimensions)
  • Eastern Cooperative Oncology Group (ECOG) performance Status less than equal to (<=) 1

Exclusion Criteria:

  • Females presenting with brain metastases or a neurological or psychiatric disorder which could interfere with proper treatment compliance
  • Previous radiotherapy, chemotherapy, or hormonal therapy for breast cancer
  • Previous history of a malignancy in last 5 years other than cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix
  • Serious concomitant infection
  • Pregnant or lactating females

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 5-Fluorouracil + Epirubicin + Cyclophosphamide
Neoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of 5-FU + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel.
Medicin: 5-Fluorouracil
5-FU will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle during neoadjuvant treatment period for 4 cycles.
Medicin: Cyclophosphamide
Cyclophosphamide will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.
Medicin: Docetaxel
Docetaxel will be administered at 100 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles during adjuvant treatment period.
Medicin: Epirubicin
Epirubicin will be administered at 100 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.
Eksperimentel: Capecitabine + Epirubicin + Cyclophosphamide
Neoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of capecitabine + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel.
Medicin: Cyclophosphamide
Cyclophosphamide will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.
Medicin: Docetaxel
Docetaxel will be administered at 100 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles during adjuvant treatment period.
Medicin: Epirubicin
Epirubicin will be administered at 100 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.
Medicin: Capecitabine
Capecitabine will be administered at 900 mg/m^2 orally twice daily on Days 1-14 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.
Andre navne:
  • Xeloda

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of participants with pathological complete tumor response Assessed by Expert Blinded Independent Review according to the Sataloff classification\n
Tidsramme: Day 120 +/- 7 days
Day 120 +/- 7 days

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of participants with pathological complete tumor response Assessed by Investigator according to the Sataloff classification
Tidsramme: Day 120 +/- 7 days
Day 120 +/- 7 days
Percentage of participants with breast conserving surgery
Tidsramme: Day 120 +/- 7 days
Day 120 +/- 7 days
Percentage of participants with objective clinical response, assessed by World Health Organization (WHO) criteria
Tidsramme: Week 15
Week 15
Percentage of participants with clinical response, assessed by WHO criteria
Tidsramme: Week 15
Week 15
Percentage of participants with disease progression, assessed by WHO criteria
Tidsramme: Baseline up to 29 +/- 1 weeks
Baseline up to 29 +/- 1 weeks
Percentage of participants with abnormalities in bilateral mammography
Tidsramme: Day 85
Day 85
Percentage of participants who died
Tidsramme: Baseline up to 29 +/- 1 weeks
Baseline up to 29 +/- 1 weeks
Percentage of participants with abnormal left ventricular ejection fraction (LVEF)
Tidsramme: Days 1-85
Days 1-85
Percentage of participants with abnormal liver ultrasound
Tidsramme: Days 1-85
Days 1-85
Percentage of participants with abnormal Chest X-Ray
Tidsramme: Days 1-85
Days 1-85
Overall survival
Tidsramme: Baseline up to 5 years
Baseline up to 5 years
Disease free survival, according to WHO criteria
Tidsramme: Baseline up to 5 years
Baseline up to 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2004

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

25. juli 2016

Først indsendt, der opfyldte QC-kriterier

25. juli 2016

Først opslået (Skøn)

27. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML16986

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner