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A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.

5 listopada 2014 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

72

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Hiszpania
      • Cordoba, Hiszpania, 14004
      • Jaen, Hiszpania, 23007
      • Lerida, Hiszpania, 25198
      • Malaga, Hiszpania, 29010
      • Zaragoza, Hiszpania, 50009
    • Barcelona
      • Sabadell, Barcelona, Barcelona, Hiszpania, 08208

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 1
Lek: Standardowa chemioterapia
Zgodnie z zaleceniami
Lek: bewacyzumab [Avastin]
15 mg/kg dożylnie w 1. dniu każdego 3-tygodniowego cyklu
Lek: Docetaksel
75 mg/m2 dożylnie w 1. dniu każdego 3-tygodniowego cyklu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Pathological Complete Response (pCR)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Objective Clinical Response
Ramy czasowe: 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
Percentage of Participants With Breast-Conserving Surgery
Ramy czasowe: Week 24
Breast-conserving surgery was defined as lumpectomy + lymphadenectomy (LA), segmentectomy + LA, quadrantectomy + LA, or other (including sentinal node extirpation tumorectomy).
Week 24
Percentage of Participants With pCR by Proliferation of Ki67
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hoffmann-La Roche

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 grudnia 2007

Zakończenie podstawowe (Rzeczywisty)

1 września 2010

Ukończenie studiów (Rzeczywisty)

1 września 2010

Daty rejestracji na studia

Pierwszy przesłany

15 listopada 2007

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 listopada 2007

Pierwszy wysłany (Oszacować)

16 listopada 2007

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

10 listopada 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 listopada 2014

Ostatnia weryfikacja

1 listopada 2014

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ML20382

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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