A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer

NCT00559845 | Completed Phase 2 Results

• 2 other identifiers: ML198842006-003291-35
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 8

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Pathological Complete Response Following Principle Investigator Review

  Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.

  Up to 7.5 years

Secondary Outcomes (5)

• Objective Response Rate

  Up to 7.5 years

• Percentage of Participants With Breast-Conserving Surgery

  Up to 7.5 years

• Percentage of Participants With Disease-Free Interval

  Months 12, 24, 36, 48, and 60

• Overall Survival

  Up to 7.5 years

• Percentage of Participants Experiencing Any Adverse Event

  Up to 7.5 years

Study Arms (1)

Bevacizumab

EXPERIMENTAL

Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.

Drug: 5-fluorouracil; Drug: Epidoxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel; Biological: Bevacizumab

Interventions

5-fluorouracil DRUG

600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.

Bevacizumab

Epidoxorubicin DRUG

90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.

Bevacizumab

Cyclophosphamide DRUG

600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.

Bevacizumab

Paclitaxel DRUG

Paclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks.

Bevacizumab

Bevacizumab BIOLOGICAL

Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.

Also known as: Avastin®

Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Unknown Facility

Napoli, Campania, 80131, Italy

Location

Unknown Facility

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

Unknown Facility

Pordenone, Friuli Venezia Giulia, 33170, Italy

Location

Unknown Facility

Genoa, Liguria, 16132, Italy

Location

Unknown Facility

Mantova, Lombardy, 46100, Italy

Location

Unknown Facility

Cuneo, Piedmont, 12100, Italy

Location

Unknown Facility

Turin, Piedmont, 10126, Italy

Location

Unknown Facility

Negrar, Veneto, 37024, Italy

Location

Related Publications (1)

• 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.

  PMID: 23642526 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fluorouracil; Epirubicin; Cyclophosphamide; Paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: February 1, 2008
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 9, 2018
• Results First Posted: April 9, 2018

Record last verified: 2016-10

Locations

IT (8)