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Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

21 aprile 2012 aggiornato da: Bapsi Chak, MD, Vanderbilt-Ingram Cancer Center

Pilot Study of Neoadjuvant Dose Dense Docetaxel With Correlative Molecular Studies in Stage II/III Breast Cancer

RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy.

PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. To determine the changes in molecular markers that occurs with single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel (either by repeat biopsy or definitive surgery).

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

  • Pathologic complete response rate (pCR) of dose dense docetaxel in the neoadjuvant setting.

Secondary

  • Safety and toxic effects of this regimen in these patients.
  • Tumor response rate (as measured by ultrasound) in patients treated with this regimen.
  • Determine whether early changes in markers of cell cycle position, proliferation, or apoptosis correlate with pathologic complete response rate in these patients.
  • Determine whether the molecular profile that predicts for chemoresponsiveness also predicts for response to radiotherapy (as measured by local recurrence) in these patients.
  • Determine whether tumors that demonstrate the greatest degree of change in protein expression patterns from pre- to post-docetaxel treatment will also be those that are most sensitive to chemotherapy (as measured by pathologic response rate) in these patients.

OUTLINE: This is a nonrandomized, open-label, pilot study.

  • Tissue Collection: Patients undergo tumor core biopsy (6-8 cores) and blood collection prior to initiating neoadjuvant docetaxel.
  • Neoadjuvant docetaxel with hematopoietic support: Patients receive docetaxel IV over 1 hour on day 1. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 or 2 of each course OR filgrastim (G-CSF) or sargramostim (GM-CSF) SC daily beginning between day 2-4 of each course and continuing until blood counts recover. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Surgery: Within 4-6 weeks after completion of neoadjuvant docetaxel, patients undergo definitive surgery.

Patients undergo tumor biopsy and blood collection periodically for pharmacokinetic, genetic, and molecular biomarker correlative studies. Samples are examined for changes in p21 protein expression (and/or p21 phosphorylation) and the protein expression profile.

After completion of study treatment, patients are followed at least every 6 months for 3 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

34

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
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, Stati Uniti, 37208
        • Meharry Medical College

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

No

Sessi ammissibili allo studio

Femmina

Descrizione

DISEASE CHARACTERISTICS:

Inclusion:

  • Histologically or cytologically confirmed invasive carcinoma of the breast by core biopsy
  • Tumor ≥ 2 cm in greatest dimension(may be either node positive or node negative disease

  • Patients with non-metastatic breast cancer who are in the judgment of the treating medical oncologist considered to be of sufficiently high risk to warrant adjuvant chemotherapy

    • Patients with internal mammary, supraclavicular and/or axillary node involvement are eligible. Patients with inflammatory breast cancer are eligible
    • Patients with T0 disease but palpable and measurable adenopathy are eligible for this trial. All sites of disease should be noted and followed

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Menopausal status not specified
  • Female ≥ 18 years old
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Hemoglobin ≥ 8 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal

  • Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:

    • AP normal AND AST or ALT ≤ 5 times ULN
    • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST or ALT normal
  • Women of child-bearing potential, must have a negative serum pregnancy test and must use effective contraception for the duration of the study and for at least 6 months after completion of study treatment
  • Patients with prior malignancies are eligible if they have been disease free for ≥ 5 years. Patients with curative treatment of non-melanomatous skin cancer, carcinoma in situ of the cervix, contralateral DCIS treated with mastectomy are eligible even if it is diagnosed in < 5 years.

PRIOR CONCURRENT THERAPY:

  • No prior anthracycline or taxane-based chemotherapy. Patients who received chemoprevention are eligible if the chemopreventive agent has been discontinued for at least one year prior to enrollment in the current study.
  • At least 1 year since prior tamoxifen for breast cancer prevention

Exclusion:

  • Prior radiotherapy to the ipsilateral breast

    • Patients who have had radiation to the contralateral breast are eligible
  • Evidence of distant metastatic disease (i.e., lung, liver, bone, brain)
  • Pregnant of breastfeeding
  • Patients who have congestive heart failure, angina pectoris, uncontrolled cardiac arrhythmia, or other significant heart disease, or who have had a myocardial infarction within the past year
  • Patients with > grade 1 peripheral neuropathy
  • Patients with a history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
  • Patients receiving an investigational anticancer drug within 3 weeks of registration
  • Patients with serious medical illness that in the judgment of the treating physician, places the patient at risk.

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: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervento terapeutico
Altro: analisi di laboratorio dei biomarcatori
analisi di laboratorio dei biomarcatori
Genetico: analisi dell'espressione proteica
analisi dell'espressione proteica
Procedura: biopsia
biopsia
Procedura: chirurgia convenzionale
chirurgia convenzionale
Droga: docetaxel
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
Altri nomi:
  • Taxotere
Procedura: neoadjuvant therapy
neoadjuvant therapy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number Participants to Achieve Pathologic Complete Response
Lasso di tempo: 3 month
whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)
3 month

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
Lasso di tempo: Through 30 days after completion of treatment
Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria
Through 30 days after completion of treatment
Tumor Response as Measured by Ultrasound
Lasso di tempo: At screening, 8 weeks and at surgery (within 14-21 days)
Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
At screening, 8 weeks and at surgery (within 14-21 days)

Collaboratori e investigatori

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

Sponsor

Vanderbilt-Ingram Cancer Center

Collaboratori

National Cancer Institute (NCI)

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 febbraio 2004

Completamento primario (Effettivo)

1 marzo 2008

Completamento dello studio (Effettivo)

1 marzo 2011

Date di iscrizione allo studio

Primo inviato

22 giugno 2006

Primo inviato che soddisfa i criteri di controllo qualità

22 giugno 2006

Primo Inserito (Stima)

23 giugno 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

27 aprile 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 aprile 2012

Ultimo verificato

1 aprile 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • VICC BRE 0368
  • VICC-BRE-0368
  • VICC-11239

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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