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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
Sponsor:
Information provided by (Responsible Party):
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.

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)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Bevacizumab

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®




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.



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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.

Information from the National Library of Medicine

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00559845     History of Changes
Other Study ID Numbers: ML19884
2006-003291-35 ( EudraCT Number )
First Posted: November 16, 2007    Key Record Dates
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
Albumin-Bound Paclitaxel
Bevacizumab
Cyclophosphamide
Fluorouracil
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic