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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003291-35 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Experimental | Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Response Following Principle Investigator Review | Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. | Up to 7.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | 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. | Up to 7.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naples | Campania | 80131 | Italy | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23642526 | Derived | 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. |
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56 participants were enrolled in 8 centers in Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months. FEC: 5-Fluorouracil 600 milligrams per meter squared (mg/m^2) intravenous (i.v.) bolus over ≤15 minutes (min); epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles. Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks. Bevacizumab: 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention to Treat (ITT) population, defined as all participants that were included in the trial and underwent surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months. FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles. Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks. Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Pathological Complete Response Following Principle Investigator Review | Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. | Intention-to-Treat (ITT) population, defined as all participants that were included in the trial and underwent surgery. | Posted | Number | percentage of participants | Up to 7.5 years |
|
Up to 7.5 years
Safety population defined as all participants who received at least one infusion of Bevacizumab.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab | FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months. FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles. Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks. Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 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. |
|
|
| Percentage of Participants With Breast-Conserving Surgery | 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. | Up to 7.5 years |
| Percentage of Participants With Disease-Free Interval | 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. | Months 12, 24, 36, 48, and 60 |
| Overall Survival | Overall survival was defined as the time from enrollment of participant to death from any cause. | Up to 7.5 years |
| Percentage of Participants Experiencing Any Adverse Event | 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. | Up to 7.5 years |
| Reggio Emilia |
| Emilia-Romagna |
| 42100 |
| Italy |
| Pordenone | Friuli Venezia Giulia | 33170 | Italy |
| Genoa | Liguria | 16132 | Italy |
| Mantua | Lombardy | 46100 | Italy |
| Cuneo | Piedmont | 12100 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Negrar | Veneto | 37024 | Italy |
| Did Not Attend Cycle 6 Hospital Visit |
|
| Premature Surgery-Investigator Decision |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Objective Response Rate | 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. | ITT population, defined as all participants that were included in the trial and underwent surgery. | Posted | Number | percentage of participants | Up to 7.5 years |
|
|
|
| Secondary | Percentage of Participants With Breast-Conserving Surgery | 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. | ITT population, defined as all participants that were included in the trial and underwent surgery. | Posted | Number | percentage of participants | Up to 7.5 years |
|
|
|
| Secondary | Percentage of Participants With Disease-Free Interval | 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. | ITT population, defined as all participants that were included in the trial and underwent surgery. Here, number of participants analyzed signifies those participants who were evaluable for the outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Months 12, 24, 36, 48, and 60 |
|
|
|
| Secondary | Overall Survival | Overall survival was defined as the time from enrollment of participant to death from any cause. | Data for the outcome measure was not collected. | Posted | Up to 7.5 years |
|
|
| Secondary | Percentage of Participants Experiencing Any Adverse Event | 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. | Safety population, defined as all participants who received at least one infusion of Bevacizumab. | Posted | Number | percentage of participants | Up to 7.5 years |
|
|
|
| 8 |
| 54 |
| 54 |
| 54 |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Retinopathy Hypertensive | Eye disorders | MedDRA (13.0) | Systematic Assessment |
|
| Febrile Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Postoperative Wound Complication | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Cardiac Imaging Procedure Abnormal | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Malignant Melanoma In Situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Ast Increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Astringent Therapy | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| 48 Months |
|
| 60 Months |
|