Completed
PHASE2
INTERVENTIONAL
NCT00559754
A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
bevacizumab [Avastin]
Type:
DRUG
Description:
15mg/kg iv on day 1 of each 3 week cycle
Name:
Docetaxel
Type:
DRUG
Description:
75mg/m2 iv on day 1 of each 3 week cycle
Name:
Standard chemotherapy
Type:
DRUG
Description:
As prescribed
Primary Outcomes
Measure:
Percentage of Participants With Pathological Complete Response (pCR)
TimeFrame:
After Week 24 (surgery)
Description:
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.
Trial Information
NCT ID
NCT00559754
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Hoffmann-La Roche
Last Updated
December 15, 2025