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

Breast Cancer Clinical Trial

Official title:

Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559845
• Other study ID #: ML19884
• Secondary ID: 2006-003291-35
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: September 12, 2017
• Start date: February 2008
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 5-fluorouracil
600 milligrams per meter squared (mg/m^2) as an intravenous (i.v.) bolus over =15 minutes every 3 weeks for 4 cycles.
• Epidoxorubicin
90 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
• Cyclophosphamide
600 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
• Paclitaxel
Paclitaxel was administered at 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective Response Rate	Objective response rate was defined as the percentage of participants with a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions; PR was defined as a 30% decrease in sum of longest diameter of target lesions.	Up to 7.5 years
Secondary	Percentage of Participants With Breast-Conserving Surgery	Rate of breast conversing surgery is defined as percentage of participants who achieved breast conversing surgery out of the ITT population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant treatment.	Up to 7.5 years
Secondary	Percentage of Participants With Disease-Free Interval	Disease-free interval was defined as the time from enrollment until recurrence of tumor or death from any cause, and was estimated using the Kaplan-Meier method. The percentage of participants without events at Months 12, 24, 36, 48, and 60 is presented.	Months 12, 24, 36, 48, and 60
Secondary	Overall Survival	Overall survival was defined as the time from enrollment of participant to death from any cause.	Up to 7.5 years
Secondary	Percentage of Participants Experiencing Any Adverse Event	An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	Up to 7.5 years