- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00559754
A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.
5 november 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
72
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Cordoba, Spanien, 14004
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Jaen, Spanien, 23007
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Lerida, Spanien, 25198
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Malaga, Spanien, 29010
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Zaragoza, Spanien, 50009
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Barcelona
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Sabadell, Barcelona, Barcelona, Spanien, 08208
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
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: 1
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Som föreskrivs
15 mg/kg iv på dag 1 i varje 3-veckorscykel
75 mg/m2 iv på dag 1 i varje 3-veckorscykel
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants With Pathological Complete Response (pCR)
Tidsram: 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: 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.
|
After Week 24 (surgery)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants With Objective Clinical Response
Tidsram: Within 28 days of enrollment, Weeks 12 and 24
|
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.
|
Within 28 days of enrollment, Weeks 12 and 24
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Percentage of Participants With Breast-Conserving Surgery
Tidsram: 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).
|
Week 24
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Percentage of Participants With pCR by Proliferation of Ki67
Tidsram: 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.
Biomarker Ki67 proliferation was defined as low (less than [<]15% ) and high (≥15%).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification
Tidsram: 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 amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by KISS1 Protein Expression
Tidsram: 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).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by Vascular Endothelial Growth Factor Receptor (VEGFR) Amplification
Tidsram: 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.
VEFGR amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by VEGFR Protein Expression
Tidsram: 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).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by Hypoxia Inducible Factor (HIF) Protein Expression
Tidsram: 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 protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
|
After Week 24 (surgery)
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Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression
Tidsram: 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 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
Tidsram: 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
Tidsram: 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).
|
After Week 24 (surgery)
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Percentage of Participants With pCR by VEGFR Gene Expression
Tidsram: 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).
|
After Week 24 (surgery)
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Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression
Tidsram: 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.
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
Tidsram: 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).
|
After Week 24 (surgery)
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Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression
Tidsram: 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.
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).
|
After Week 24 (surgery)
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Percentage of Participants With pCR by ENOS Gene Expression
Tidsram: 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).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by Phosphorylated MAP Kinase (pMAPK) Gene Expression
Tidsram: 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.
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).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by Angiotensin II Receptor Type I (AGTR) Gene Expression
Tidsram: 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.
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).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by KISS1 Gene Expression
Tidsram: 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).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by RKISS1 Gene Expression
Tidsram: 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.
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).
|
After Week 24 (surgery)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2007
Primärt slutförande (Faktisk)
1 september 2010
Avslutad studie (Faktisk)
1 september 2010
Studieregistreringsdatum
Först inskickad
15 november 2007
Först inskickad som uppfyllde QC-kriterierna
15 november 2007
Första postat (Uppskatta)
16 november 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 november 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 november 2014
Senast verifierad
1 november 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hudsjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Bröstsjukdomar
- Bröstneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Docetaxel
- Bevacizumab
Andra studie-ID-nummer
- ML20382
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 .
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