A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00559845|
Recruitment Status : Completed
First Posted : November 16, 2007
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: 5-fluorouracil Drug: Epidoxorubicin Drug: Cyclophosphamide Drug: Paclitaxel Biological: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced Breast Cancer|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
600 milligrams per meter squared (mg/m^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.
90 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
600 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
Paclitaxel was administered at 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.
Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.
Other Name: Avastin®
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559845
|Napoli, Campania, Italy, 80131|
|Reggio Emilia, Emilia-Romagna, Italy, 42100|
|Pordenone, Friuli-Venezia Giulia, Italy, 33170|
|Genova, Liguria, Italy, 16132|
|Mantova, Lombardia, Italy, 46100|
|Cuneo, Piemonte, Italy, 12100|
|Torino, Piemonte, Italy, 10126|
|Negrar, Veneto, Italy, 37024|
|Study Director:||Clinical Trials||Hoffmann-La Roche|