- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00343512
Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer
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).
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Tennessee
-
Nashville, Tennessee, Förenta staterna, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
Nashville, Tennessee, Förenta staterna, 37208
- Meharry Medical College
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Terapeutisk intervention
|
laboratoriebiomarköranalys
analys av proteinuttryck
biopsi
konventionell kirurgi
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
Andra namn:
neoadjuvant therapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number Participants to Achieve Pathologic Complete Response
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VICC BRE 0368
- VICC-BRE-0368
- VICC-11239
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Bröstcancer
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital och andra samarbetspartnersAvslutadDen kliniska tillämpningsguiden för Conebeam Breast CTKina
-
ETOP IBCSG Partners FoundationAvslutadBreast Cancer Invasive NosItalien
-
Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAvslutadBreast Cancer Invasive NosSpanien
-
University Health Network, TorontoAvslutadBreast Cancer Invasive Nos | Primär invasiv bröstcancerKanada
-
Novartis PharmaceuticalsAvslutadMetastaserad bröstcancer (MBC) | Locally Advance Breast Cancer (LABC)Storbritannien, Spanien
-
Pomeranian Medical University SzczecinMaria Sklodowska-Curie National Research Institute of Oncology; Regional...OkändBRCA1-mutation | Breast Cancer Invasive NosPolen
-
McMaster UniversityCanadian Breast Cancer FoundationAvslutadBreast Cancer Invasive Nos | Steg 0 BröstkarcinomKanada
Kliniska prövningar på laboratoriebiomarköranalys
-
Recep Tayyip Erdogan University Training and Research...Hacettepe UniversityAvslutadAmputation | Diabetisk polyneuropatiKalkon
-
Liao Jian AnRekryteringHuvud- och halscancerTaiwan
-
University of California, San FranciscoRekryteringFriska | Fertilitetsstörningar | Manlig infertilitet | Infertilitet, manligFörenta staterna
-
Oregon Health and Science University4DMedicalAnmälan via inbjudanLungsjukdomar | KOL | Luftvägssjukdom | DyspnéFörenta staterna
-
Progenity, Inc.AvslutadDowns syndrom | Aneuploidi | DiGeorges syndrom | Turnersyndrom | Klinefelters syndrom | Kromosomradering | Edwards syndrom | Pataus syndromFörenta staterna
-
Medwave Estudios LimitadaAsociación Chilena de SeguridadOkändYrkesmässig exponering | Muskuloskeletala sjukdomarChile
-
Healthy.io Ltd.Avslutad
-
Modarres HospitalAvslutadKomplikationer | Bildvägledd biopsi | Njure GlomerulusIran, Islamiska republiken
-
Assistance Publique - Hôpitaux de ParisHar inte rekryterat ännuCochleaimplantation | Grundlig medfödd dövhetFrankrike
-
Duke UniversityIndragenAntikoagulations- och trombostest (AT-POCT)Förenta staterna