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- Klinische proef NCT00559754
A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.
5 november 2014 bijgewerkt door: Hoffmann-La Roche
An Open Label Study to Assess the Effect of a Combination of Avastin and Docetaxel and Sequential Chemotherapy on Pathological Response in Patients With Primary Operable HER2 Negative Breast Cancer
This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer.
Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle).
They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with Avastin (15mg/kg on day 1 of each cycle).
The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
72
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Cordoba, Spanje, 14004
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Jaen, Spanje, 23007
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Lerida, Spanje, 25198
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Malaga, Spanje, 29010
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Zaragoza, Spanje, 50009
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Barcelona
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Sabadell, Barcelona, Barcelona, Spanje, 08208
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- female patients, >=18 years of age;
- primary HER2-negative operable breast cancer;
- tumor >2cm in size;
- ECOG performance status 0-1.
Exclusion Criteria:
- previous treatment for breast cancer;
- metastatic disease;
- current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) or full-dose anticoagulants for therapeutic purposes;
- clinically significant cardiovascular disease.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
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Zoals voorgeschreven
15 mg/kg iv op dag 1 van elke cyclus van 3 weken
75 mg/m2 iv op dag 1 van elke cyclus van 3 weken
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants With Pathological Complete Response (pCR)
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria: 1) the primary tumor was Grade 5 (no malignant cells identified at the location of the primary tumor (ductal carcinoma in situ may be present); 2) no involvement was identified in the lymph nodes; 3) the tumour size at evaluation of the surgical piece was 0 centimeters (cm); and 4) the pathological staging of the tumour from the surgical piece was pT0pN0pM0, the stage is not applicable (NA).
It will only be considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
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After Week 24 (surgery)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Percentage of Participants With Objective Clinical Response
Tijdsspanne: Within 28 days of enrollment, Weeks 12 and 24
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Overall clinical response is the best response obtained through physical examination and/or radiological tests after completion of chemotherapy cycles.
The percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) and was categorized as clinical response (CR+PR) or clinical benefit (CR+PR+ no change [NC]).
Per RECIST, CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level.
PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions.
No unequivocal progression of non-target disease.
No new lesions.
Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.
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Within 28 days of enrollment, Weeks 12 and 24
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Percentage of Participants With Breast-Conserving Surgery
Tijdsspanne: Week 24
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Breast-conserving surgery was defined as lumpectomy + lymphadenectomy (LA), segmentectomy + LA, quadrantectomy + LA, or other (including sentinal node extirpation tumorectomy).
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Week 24
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Percentage of Participants With pCR by Proliferation of Ki67
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
Biomarker Ki67 proliferation was defined as low (less than [<]15% ) and high (≥15%).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
KISS1 amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by KISS1 Protein Expression
Tijdsspanne: After Week 24 (surgery)
|
The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
KISS1 protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Vascular Endothelial Growth Factor Receptor (VEGFR) Amplification
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
VEFGR amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by VEGFR Protein Expression
Tijdsspanne: After Week 24 (surgery)
|
The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
VEGFR protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Hypoxia Inducible Factor (HIF) Protein Expression
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
HIF protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
ENOS protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Angiotension Protein Expression
Tijdsspanne: After Week 24 (surgery)
|
The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
Angiotensin protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Vascular Endothelial Growth Factor (VEGF) Gene Expression
Tijdsspanne: After Week 24 (surgery)
|
The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
VEGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by VEGFR Gene Expression
Tijdsspanne: After Week 24 (surgery)
|
The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
VEGFR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
pAKT gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by HIF Gene Expression
Tijdsspanne: After Week 24 (surgery)
|
The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
HIF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
IGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by ENOS Gene Expression
Tijdsspanne: After Week 24 (surgery)
|
The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
ENOS gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Phosphorylated MAP Kinase (pMAPK) Gene Expression
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
pMAPK gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Angiotensin II Receptor Type I (AGTR) Gene Expression
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
AGTR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by KISS1 Gene Expression
Tijdsspanne: After Week 24 (surgery)
|
The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
KISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by RKISS1 Gene Expression
Tijdsspanne: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
RKISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2007
Primaire voltooiing (Werkelijk)
1 september 2010
Studie voltooiing (Werkelijk)
1 september 2010
Studieregistratiedata
Eerst ingediend
15 november 2007
Eerst ingediend dat voldeed aan de QC-criteria
15 november 2007
Eerst geplaatst (Schatting)
16 november 2007
Updates van studierecords
Laatste update geplaatst (Schatting)
10 november 2014
Laatste update ingediend die voldeed aan QC-criteria
5 november 2014
Laatst geverifieerd
1 november 2014
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
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Docetaxel
- Bevacizumab
Andere studie-ID-nummers
- ML20382
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 .
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