Phase 2 N=72 Treatment

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00559754 ↗

Enrolled (actual)

Serious AEs

18.1%

Results posted

Nov 2014

Primary outcome: Primary: Percentage of Participants With Pathological Complete Response (pCR) — 24.2 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bevacizumab [Avastin] (Drug); Docetaxel (Drug); Standard chemotherapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Hoffmann-La Roche
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Pathological Complete Response (pCR)	24.2	—
SECONDARY Percentage of Participants With Objective Clinical Response	88.9; 98.6	—
SECONDARY Percentage of Participants With Breast-Conserving Surgery	62.7	—
SECONDARY Percentage of Participants With pCR by Proliferation of Ki67	24.0; 13.3	0.4915
SECONDARY Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification	12.5; 30.77; 50.0	0.4864
SECONDARY Percentage of Participants With pCR by KISS1 Protein Expression	27.8; 66.7; 50.0	0.3613
SECONDARY Percentage of Participants With pCR by Vascular Endothelial Growth Factor Receptor (VEGFR) Amplification	0; 33.3; 0	0.6605
SECONDARY Percentage of Participants With pCR by VEGFR Protein Expression	28.6; 40.0; 20.0	0.8311
SECONDARY Percentage of Participants With pCR by Hypoxia Inducible Factor (HIF) Protein Expression	40.0; 12.5; 60.0	0.2230
SECONDARY Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression	29.2; 40.0; 25.0	0.8696
SECONDARY Percentage of Participants With pCR by Angiotension Protein Expression	7.1; 0.0; 63.6	0.0074 sig
SECONDARY Percentage of Participants With pCR by Vascular Endothelial Growth Factor (VEGF) Gene Expression	100.0; 30.3	0.3235
SECONDARY Percentage of Participants With pCR by VEGFR Gene Expression	0.0; 40.7	0.0693
SECONDARY Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression	NA; 32.4	—
SECONDARY Percentage of Participants With pCR by HIF Gene Expression	44.4; 28.0	0.4254
SECONDARY Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression	NA; 32.4	—
SECONDARY Percentage of Participants With pCR by ENOS Gene Expression	0; 33.3	1.0000
SECONDARY Percentage of Participants With pCR by Phosphorylated MAP Kinase (pMAPK) Gene Expression	33.3; 0; 33.3	1.0000
SECONDARY Percentage of Participants With pCR by Angiotensin II Receptor Type I (AGTR) Gene Expression	NA; 30.3	—
SECONDARY Percentage of Participants With pCR by KISS1 Gene Expression	0.0; 33.3	1.0000
SECONDARY Percentage of Participants With pCR by RKISS1 Gene Expression	NA; 32.4	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00559754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.