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

• ClinicalTrials.gov Identifier: NCT00559845
• Recruitment Status: Completed
• First Posted: November 16, 2007
• Results First Posted: April 9, 2018
• Last Update Posted: April 9, 2018
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: 5-fluorouracil; Drug: Epidoxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel; Biological: Bevacizumab	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm

Intervention/treatment

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

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.; Drug: Epidoxorubicin; 90 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.; Drug: Cyclophosphamide; 600 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.; Drug: 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.; Other Name: Avastin®

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Italy

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

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00559845
• Other Study ID Numbers: ML19884; 2006-003291-35 ( EudraCT Number )
• First Posted: November 16, 2007
• Results First Posted: April 9, 2018
• Last Update Posted: April 9, 2018
• Last Verified: October 2016

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Paclitaxel; Cyclophosphamide; Bevacizumab; Fluorouracil; Epirubicin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antimetabolites; Antimetabolites, Antineoplastic