Clinical trial NCT00559845: A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer
Official title: Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced 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: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* female participants, \>=18 years of age;
* stage III, or inflammatory breast cancer;
* estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;
* normal left ventricular ejection fraction (LVEF).

Exclusion Criteria:

* previous chemotherapy/endocrine therapy;
* evidence of distant metastatic disease;
* other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
* chronic daily treatment with \>325 milligram per day (mg/day) aspirin, or \>75mg/day clopidogrel.

Primary outcomes:
measure: Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
timeFrame: Up to 7.5 years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Up to 7.5 years
measure: Percentage of Participants With Breast-Conserving Surgery
timeFrame: Up to 7.5 years
measure: Percentage of Participants With Disease-Free Interval
timeFrame: Months 12, 24, 36, 48, and 60
measure: Overall Survival
timeFrame: Up to 7.5 years
measure: Percentage of Participants Experiencing Any Adverse Event
timeFrame: Up to 7.5 years
Other outcomes:
Locations:
city: Napoli
country: Italy
state: Campania
city: Reggio Emilia
country: Italy
state: Emilia-Romagna
city: Pordenone
country: Italy
state: Friuli-Venezia Giulia
city: Genova
country: Italy
state: Liguria
city: Mantova
country: Italy
state: Lombardia
city: Cuneo
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Negrar
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Clavarezza M, Turazza M, Aitini E, Saracchini S, Garrone O, Durando A, De Placido S, Bisagni G, Levaggi A, Bighin C, Restuccia E, Scalamogna R, Galli A, Del Mastro L. Phase II open-label study of bevacizumab combined with neoadjuvant anthracycline and taxane therapy for locally advanced breast cancer. Breast. 2013 Aug;22(4):470-5. doi: 10.1016/j.breast.2013.03.012. Epub 2013 May 1.