- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00365365
Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer
A Phase IIb, Randomized, Multicenter, Noncomparative Pilot Study of the Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab ± Trastuzumab for the Adjuvant Treatment of Patients With Node-Positive & High-Risk Node-Negative Breast Cancer
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
- Geneesmiddel: Doxorubicin and cyclophosphamide (AC) + bevacizumab
- Geneesmiddel: Docetaxel (T) + bevacizumab
- Geneesmiddel: Bevacizumab maintenance therapy
- Geneesmiddel: Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab
- Geneesmiddel: Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab
- Geneesmiddel: Bevacizumab and trastuzumab maintenance therapy
Gedetailleerde beschrijving
In this study, participants were stratified according to HER2 status at the time of enrollment. HER2-negative participants were randomized in a 1:1 ratio to either stratum 1 (AC->T sequential + bevacizumab) or stratum 2 (TAC + bevacizumab). All HER2-positive participants were assigned to stratum 3 (TCH + bevacizumab).
The study included a treatment period of 1 year, followed by a 2 year posttreatment survival follow-up period.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
-
-
New Jersey
-
Bridgewater, New Jersey, Verenigde Staten, 08807
- Sanofi-Aventis Administrative Office
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
Inclusion Criteria:
- Women >/= 18 years of age.
- Histologically proven breast cancer with an interval between definitive breast surgery that includes axillary lymph node (LN) dissection or axillary nodal evaluation and study registration of < 60 days. (Note: Cycle 1 of chemotherapy treatment may NOT be infused until > 28 days after the date of definitive breast surgery and the participant must be recovered from any clinically significant toxicity thereof.)
- Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection (axillary lymph node evaluation can be either full axillary node dissection or sentinel LN evaluation followed by dissection if sentinel LN is positive) for operable breast cancer (pT1-4 [including inflammatory], pNO-3, and MO). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.
- Subjects must be either lymph node-positive (pN1-3) or lymph node-negative (pN0) with high-risk features as determined by Investigator.
High-risk, lymph node-negative participants, (pN0) will be defined as subjects having invasive adenocarcinoma with either a negative sentinel node biopsy (pN0[sn]) OR negative lymph node dissection (pN0) disease AND tumor size > 2 cm or tumor size >/= 1 cm with at least one of the following factors:
- negative estrogen receptor (ER) and negative progesterone receptor (PR) status
- histologic and/or nuclear Grade 2-3; or
- age < 35 years
- HER2/neu positive or negative tumors are eligible. HER2 positivity must be documented by fluorescence in situ hybridization (FISH).
- Estrogen and progesterone receptor status must be performed on the primary tumor prior to study entry. Results must be pending or known at the time of study entry.
- Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) or shortening fraction (multiple-gated acquisition [MUGA] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.
Hematology evaluation within 2 weeks prior to study entry:
- Absolute neutrophil count (ANC) >/= 1,500/μL
- Platelets >/= 100,000/μL
- Hemoglobin >/= 9 g/dL
Hepatic function evaluation within 2 weeks prior to study entry:
- Total bilirubin </= ULN for the institution
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be in the acceptable range.
- Complete staging work-up as follows: All subjects must have an appropriate radiographic evaluation, e.g., computed tomography (CT), positron emission tomography (PET)/CT, and/or (magnetic resonance imaging) MRI of the brain, chest, abdomen and pelvis, and imaging of bone by either a bone scan or PET scan. In cases of positive bone imaging, a bone X-ray or MRI evaluation is mandatory to rule out the possibility of metastatic bone scan disease. Other tests may be performed as clinically indicated. It is recommended that all baseline staging should be completed within 35 days prior to study entry.
Exclusion Criteria:
- Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
- Prior anthracycline therapy, taxoids or platinum salts for any malignancy.
- Prior radiation therapy for breast cancer or any radiotherapy to the chest wall for any other malignancy.
- Bilateral invasive breast cancer.
- Pregnant or lactating subjects
- Cardiac disease or risk for same as judged by Investigator
- Other serious illness or medical conditions such as (partial list- review with Investigator) history of significant neurologic or psychiatric disorders that would prohibit the understanding and giving of informed consent, active uncontrolled infection, active peptic ulcer, unstable diabetes mellitus or subjects with symptomatic, intrinsic lung disease resulting in dyspnea at rest
- Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention of breast cancer. Subjects must have discontinued these agents prior to study entry.
- Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to study entry.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational non-marketed drug within 30 days prior to study entry.
- Concurrent treatment with any other anti-cancer therapy.
- Male subjects, as no clinical efficacy or safety data are available from phase I-II studies.
- Chemotherapy and/or bevacizumab may not be given until > 7 days following a minor surgical procedure. Chemotherapy may be given without bevacizumab in circumstances in which the participant has recovered sufficiently to receive chemotherapy but has not yet reached a 28 day time point at which bevacizumab could be administered.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Stratum 1 (AC->T + bevacizumab)
HER2-negative participants administered
|
For every 3-week cycle
Andere namen:
For every 3-week cycle
Note: The starting dose of docetaxel was reduced to 75 mg/m^2 if toxicity occurred that met the criteria for doxorubicin dose reduction
Andere namen:
- bevacizumab 15 mg/kg was infused IV Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed.
Andere namen:
|
Experimenteel: Stratum 2 (TAC + bevacizumab)
HER2-negative participants administered
|
- bevacizumab 15 mg/kg was infused IV Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed.
Andere namen:
For every 3-week cycle
Andere namen:
|
Experimenteel: Stratum 3 (TCH + bevacizumab)
All HER2-positive participants administered
|
For every 3-week cycle
Andere namen:
Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF)
Tijdsspanne: from the first dose of study medication up to the end of follow-up (up to 3 yrs)
|
Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance therapy. Grade 3-4 CHF were identified through a clinical review of all study collected investigator verbatim and the Medical Dictionary for Regulatory Activities (MedDRA). The preferred terms (PT) cardiac failure congestive, cardiomyopathy, and ejection fraction decreased were associated with CHF. |
from the first dose of study medication up to the end of follow-up (up to 3 yrs)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Safety - Number of Participants With Adverse Events (AE)
Tijdsspanne: from the administration of the first dose of study medication up to 30 days after the last dose of study medication; events ongoing at the time of discontinuation were monitored in the follow-up period until resolution.
|
An adverse event was any untoward medical occurrence in a participant of the clinical investigation, regardless of the relationship to study treatment. A serious adverse event (SAE) was an AE that at any dose (including overdose) resulted in death, was life-threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect, and/or was medically important. Treatment-emergent adverse events (TEAE) were defined as AEs that developed or worsened in severity during the on-treatment period. |
from the administration of the first dose of study medication up to 30 days after the last dose of study medication; events ongoing at the time of discontinuation were monitored in the follow-up period until resolution.
|
Disease-free Survival (DFS) Rate
Tijdsspanne: from the administration of the first-dose of study medication up to 12 months, 18 months and 24 months
|
DFS was defined as the time from the administration of the first-dose of study medication until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. DFS rate was the probability of being disease free and alive at a particular time. DFS rates were estimated using Kaplan-Meier Method, and 95% confidence intervals were computed using the method of Kalbfleisch and Prentice. For participants who did have objective recurrence of tumor and who were still on study at the time of an analysis, or who were given antitumor treatment other than the study treatment, or who were removed from study follow-up prior to documentation of the tumor recurrence, DFS was censored at the last date the participant was known to be disease-free. |
from the administration of the first-dose of study medication up to 12 months, 18 months and 24 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Vicki Erickson, MSN, Sanofi
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Huidziektes
- Neoplasmata
- Neoplasmata per site
- Borst ziekten
- Borstneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antireumatische middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Antibiotica, antineoplastiek
- Docetaxel
- Cyclofosfamide
- Carboplatine
- Trastuzumab
- Bevacizumab
- Doxorubicine
- Liposomale doxorubicine
Andere studie-ID-nummers
- DOCET_L_00714
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Borstkanker
-
BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
-
Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University en andere medewerkersVoltooidDe klinische toepassingsgids van Conebeam Breast CTChina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
-
University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
-
Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Nog niet aan het wervenAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
Klinische onderzoeken op Doxorubicin and cyclophosphamide (AC) + bevacizumab
-
National Cancer Institute (NCI)VoltooidLokaal geavanceerde pancreas neuro-endocriene tumor | Pancreas neuro-endocriene tumor G1 | Neuro-endocriene tumor van de pancreas G2 | Alvleesklier Vipoma | Pancreas gastrinoom | Geavanceerde pancreas neuro-endocriene tumorVerenigde Staten, Canada
-
National Cancer Institute (NCI)Actief, niet wervendCarcinoïde tumor | Neuro-endocrien neoplasma | Colorectale neuro-endocriene tumor G1 | Gastrische neuro-endocriene tumor G1 | Neuro-endocriene tumor G2Verenigde Staten
-
CelgeneVoltooid