Clinical trial NCT00559754: A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Pathological Complete Response (pCR)
timeFrame: After Week 24 (surgery)
Secondary outcomes:
measure: Percentage of Participants With Objective Clinical Response
timeFrame: Within 28 days of enrollment, Weeks 12 and 24
measure: Percentage of Participants With Breast-Conserving Surgery
timeFrame: Week 24
measure: Percentage of Participants With pCR by Proliferation of Ki67
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by KISS1 Protein Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by Vascular Endothelial Growth Factor Receptor (VEGFR) Amplification
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by VEGFR Protein Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by Hypoxia Inducible Factor (HIF) Protein Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by Angiotension Protein Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by Vascular Endothelial Growth Factor (VEGF) Gene Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by VEGFR Gene Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by HIF Gene Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by ENOS Gene Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by Phosphorylated MAP Kinase (pMAPK) Gene Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by Angiotensin II Receptor Type I (AGTR) Gene Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by KISS1 Gene Expression
timeFrame: After Week 24 (surgery)
measure: Percentage of Participants With pCR by RKISS1 Gene Expression
timeFrame: After Week 24 (surgery)
Other outcomes:
Locations:
city: Sabadell, Barcelona
country: Spain
state: Barcelona
city: Cordoba
country: Spain
city: Jaen
country: Spain
city: Lerida
country: Spain
city: Malaga
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: