- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00559754
A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.
5 novembre 2014 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
72
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
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Cordoba, Spagna, 14004
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Jaen, Spagna, 23007
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Lerida, Spagna, 25198
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Malaga, Spagna, 29010
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Zaragoza, Spagna, 50009
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Barcelona
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Sabadell, Barcelona, Barcelona, Spagna, 08208
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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
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.
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: 1
|
Come prescritto
15 mg/kg iv il giorno 1 di ciascun ciclo di 3 settimane
75 mg/m2 iv il giorno 1 di ciascun ciclo di 3 settimane
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of Participants With Pathological Complete Response (pCR)
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of Participants With Objective Clinical Response
Lasso di tempo: 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
Lasso di tempo: Week 24
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression
Lasso di tempo: 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).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by Angiotension Protein Expression
Lasso di tempo: 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).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by Vascular Endothelial Growth Factor (VEGF) Gene Expression
Lasso di tempo: 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)
|
Percentage of Participants With pCR by VEGFR Gene Expression
Lasso di tempo: 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)
|
Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression
Lasso di tempo: 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).
|
After Week 24 (surgery)
|
Percentage of Participants With pCR by HIF Gene Expression
Lasso di tempo: 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)
|
Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression
Lasso di tempo: 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)
|
Percentage of Participants With pCR by ENOS Gene Expression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 dicembre 2007
Completamento primario (Effettivo)
1 settembre 2010
Completamento dello studio (Effettivo)
1 settembre 2010
Date di iscrizione allo studio
Primo inviato
15 novembre 2007
Primo inviato che soddisfa i criteri di controllo qualità
15 novembre 2007
Primo Inserito (Stima)
16 novembre 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
10 novembre 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 novembre 2014
Ultimo verificato
1 novembre 2014
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie della pelle
- Neoplasie
- Neoplasie per sede
- Malattie del seno
- Neoplasie mammarie
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Docetaxel
- Bevacizumab
Altri numeri di identificazione dello studio
- ML20382
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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