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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: 5-fluorouracil; Drug: Epidoxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel; Biological: Bevacizumab

• Registration Number: NCT00559845
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Study Start: 2008-02
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-10
• Results First Submitted: 2016-10-31
• Results First Submitted QC: 2017-09-12
• Last Update Submitted: 2017-09-12
• Results First Posted: 2018-04-09
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Bevacizumab	Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
Bevacizumab	Epidoxorubicin	Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
Bevacizumab	5-fluorouracil	Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
Bevacizumab	Paclitaxel	Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
Bevacizumab	Cyclophosphamide	Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Pathological Complete Response Following Principle Investigator Review	Up to 7.5 years	Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Disease-Free Interval	Months 12, 24, 36, 48, and 60	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.
Objective Response Rate	Up to 7.5 years	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.
Percentage of Participants With Breast-Conserving Surgery	Up to 7.5 years	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.
Percentage of Participants Experiencing Any Adverse Event	Up to 7.5 years	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.
Overall Survival	Up to 7.5 years	Overall survival was defined as the time from enrollment of participant to death from any cause.