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Primary Systemic Therapy in Operable/Locally Advanced Breast Cancer

2 maggio 2016 aggiornato da: University of Arkansas

Primary Systemic Therapy Using Sequential Docetaxel/Cyclophosphamide/Bevacizumab Followed by Doxorubicin in Operable/Locally Advanced Breast Cancer

The main purpose of this study is to find out what effects taking the drug bevacizumab together with two chemotherapeutic agents, docetaxel and cyclophosphamide followed by doxorubicin alone before surgery will on breast cancer. Bevacizumab will be given for twelve weeks in combination with chemotherapy then it ill be held during the administration of doxorubicin. Twenty-eight to fifty-six days after undergoing surgery, all patients will receive nine three-weekly infusions of bevacizumab.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Prior to being enrolled in this study, they will undergo an evaluation to determine eligibility. The study doctor will obtain a complete medical history, complete a physical examination including blood pressure and heart rate. The doctor will also obtain a baseline ECG as well as blood tests (approximately two tablespoons of blood). In order to decrease the effects of food, exercise and the sleep/wake cycle variability, all blood samples must be taken between 8AM - 10AM and patients will need to fast (no food or drink) for 10 hours prior to the blood test. Patients will also need to strain from working out prior to the blood test. The study will ask for a list of current medications. Patients will not be eligible if they have a history of or now require long-term anticoagulant (blood thinner) therapy (i.e. Coumadin or anything patients may be taking to prevent blood clots) have an allergy to bevacizumab or any other drugs used in the study.

Many of the following evaluations are commonly done to determine diagnosis and/or stage of breast cancer and may have already had some of all of them done. If the following procedures were not done within three weeks, they will need to be done again prior to receiving any study therapy.

  • Diagnosis of breast cancer by fine needle aspiration or core needle biopsy will be required for entry in this study.
  • Clip Placement - a clip will be placed in the tumor during the core biopsies as a marker to assist surgeons at the time of surgery.
  • Tumor Clip Placements - a caliper is similar to a ruler and is used to measure the tumor from the outside of the body instead of always having to use an ultrasound or MRI.
  • Tumor Ultrasound - this is a non-invasive exam that uses sound waves to produce a picture of your tumor.

All study participants will be treated with bevacizumab 15 mg/kg plus docetaxel 75 mg/m2 and cyclophosphamide 500 mg/m2 every three weeks for a total of four treatments. Three weeks after the completion of this part of the treatment patients will start receiving doxorubicin 60 mg/m2 every three weeks for a total of four treatments. All these drugs will be given as intravenous infusion on the first day of each three-week period.

Patients will come in for every three week visits and have a physical exam including blood pressure and heart rate. Medications lists will be taken and any side effects that may have been experienced. Tumor caliper measurements will be done and blood will be drawn at each of these visits.

A mammogram and MUGA scan will be done again just prior to surgery. Patients will undergo tumor surgery approximately six months after treatment. Patients will need to visit the study physician one month after surgery for another physical examination including blood pressure and heart rate, an assessment of any side effects and a list of current medications.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
        • University of Arkansas For Medical Sciences

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • The diagnosis of breast cancer established by biopsy.
  • Normal kidney function
  • Normal LVEF evaluated by MUGA Scan
  • >18 years of age
  • Good performance status defined by ECOG scale of 0 or 1
  • Consent
  • Women of childbearing potential must have a negative pregnancy test.
  • Use of effective means of contraception in subjects of child-bearing potential while on treatment and for at least 3 months thereafter.
  • Peripheral Neuropathy: must be < grade 1
  • Hematologic (minimal values)
  • Absolute neutrophil count >1,500/mm3
  • Hemoglobin >8.0 g/dl
  • Platelet count >100,000/mm3
  • Hepatic
  • Total bilirubin <ULN
  • AST, ALT, Alkaline Phosphatase must be within range

Exclusion Criteria:

  • Patients with locally advanced breast cancer with skin ulcerations
  • Stage IV breast cancer
  • Inflammatory breast cancer
  • Allergy to any component of the treatment regimen
  • Women who are breast feeding
  • Pregnancy or refusal to use effective contraception
  • Inability to comply with study and/or follow-up procedures.
  • Current, recent, or planned participation in a experimental drug study
  • Blood pressure of >150/100 mmHg. Essential hypertension well controlled with anti hypertensives is not an exclusion criterion.
  • unstable angina
  • New York Heart Association Grade II or greater congestive heart failure
  • history of myocardial infarction within 6 months
  • history of stroke within 6 months
  • Clinical significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Presence of central nervous system or brain metastasis
  • major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0
  • Minor surgical procedure such as fine needle aspirations or core biopsy within 7 days prior to day 0
  • Pregnant or lactating
  • Urine protein: creatinine ratio >1.0 at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  • Serious, non-healing wound, ulcer, or bone fracture

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention: Dtx Cyclophosphamide Bev
Docetaxel 75m/m2 Cyclophosphamide 500 mg/m2 Bevacizumab 15 mg/kg
Droga: Bevacizumab
IV 15mg/kg 21 days
Altri nomi:
  • Avastin
Droga: Cyclophosphamide
500mg per meter squared, IV every 21 days
Altri nomi:
  • Cytoxan
Droga: Docetaxel
60 mg per meter squared, IV every 21 days
Altri nomi:
  • Taxotere
  • Adriamicina

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Pathological Complete Response.
Lasso di tempo: Participants were assessed during surgery, an average of one hour
Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.
Participants were assessed during surgery, an average of one hour

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Clinical Complete Response in Breast and the Axillary Lymph Nodes After the Completion of Chemotherapy and Bevacizumab.
Lasso di tempo: At completion of chemotherapy treatment, an average of one hour
Clinical complete response was defined using RECIST response categories as the clinical response to chemotherapy
At completion of chemotherapy treatment, an average of one hour
Percentage of Participants With Grade 3 or 4 Adverse Events
Lasso di tempo: After each chemotherapy infusion, approximately one hour
Percent of participants who had at least one grade 3 or 4 adverse event
After each chemotherapy infusion, approximately one hour
To Measure the Change in Left Ventricular Ejection Fraction (LVEF) From Baseline
Lasso di tempo: Immediately before treatment and 1 year after start of treatment
Absolute change in LVEF, where LVEF values are measured in percentage units
Immediately before treatment and 1 year after start of treatment
Percentage of Participants With Pathologic Complete Response (pCR) Among Those With Triple Negative Breast Cancer
Lasso di tempo: at surgery, one day
pCR rate for triple negative patients--percent
at surgery, one day

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Arkansas

Collaboratori

Genentech, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2005

Completamento primario (Effettivo)

1 febbraio 2015

Completamento dello studio (Effettivo)

1 febbraio 2015

Date di iscrizione allo studio

Primo inviato

12 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

12 settembre 2005

Primo Inserito (Stima)

20 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 maggio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UARK 2004-59

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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