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Completed

NCT Number: NCT00559845

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Naples, Campania, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

epidoxorubicin

Drug

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

Cyclophosphamide

Drug

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

paclitaxel

Drug

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

Bevacizumab

Biological

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

Other names: Avastin®

Primary outcomes

  1. Percentage of Participants With Pathological Complete Response Following Principle Investigator Review

    Time frame: 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 outcomes

  1. Objective Response Rate

    Time frame: 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.

  2. Percentage of Participants With Breast-Conserving Surgery

    Time frame: 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.

  3. Percentage of Participants With Disease-Free Interval

    Time frame: 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.

  4. Overall Survival

    Time frame: Up to 7.5 years

    Overall survival was defined as the time from enrollment of participant to death from any cause.

  5. Percentage of Participants Experiencing Any Adverse Event

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Nov 16, 2007
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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