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First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast cancer who have not received prior chemotherapy for locally recurrent or metastatic disease.
Arm A:
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks
Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
Arm B:
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks
Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
In both arms treatment will be given until first disease progression (PD), unacceptable toxicity or withdrawal of patient consent.
For patients who stop chemotherapy for any reason before PD (e.g. toxicity) the other treatment should be given as monotherapy until PD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Bev+Pac | Active Comparator | Bevacizumab plus Paclitaxel |
|
| B Bev+Cap | Active Comparator | Bevacizumab plus Capecitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab and Paclitaxel | Biological | A: Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (PP Population) | Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250. | Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years |
| Overall Survival (ITT Population) | Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 50% of information was 0.0014. Alpha spent at final analysis after 99% of information was 0.0250. | Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Observation Time (ITT Population) | Median observation time estimated with reverse Kaplan-Meier methods. Observation time (in months) is defined as time from randomization to the day the patient was last confirmed to be alive. In case of patient deaths the time was censored at the day of death. | Up to approximately 6 years |
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Inclusion Criteria
Written informed consent obtained prior to any study-specific procedure.
Age ≥18 years.
Able to comply with the protocol.
Histologically or cytologically confirmed, HER2-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent.
Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-2.
Life expectancy more than 12 weeks.
Prior (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was more than 6 months prior to randomization. However, if (neo)adjuvant chemotherapy was:
Prior adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that last fraction of radiotherapy occurred at least 6 months prior to randomization. Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that:
Adequate left ventricular ejection function (LVEF) at baseline, defined as LVEF ≥ 50% by either echocardiogram or multigated acquisition scan (MUGA).
Adequate hematological function
Adequate liver function
Adequate renal function
The use of full-dose oral or parenteral anticoagulants is permitted as long as the patient has been on a stable level of anticoagulation for at least two weeks at the time of randomization
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Christoph C Zielinski, MD | Dep. of Internal Medicin I, Oncology, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Leoben | Leoben | 8700 | Austria | |||
| Hospital Barmherzige Schwestern |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34037241 | Derived | Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2. | |
| 27501767 | Derived | Zielinski C, Lang I, Inbar M, Kahan Z, Greil R, Beslija S, Stemmer SM, Zvirbule Z, Steger GG, Melichar B, Pienkowski T, Sirbu D, Petruzelka L, Eniu A, Nisenbaum B, Dank M, Anghel R, Messinger D, Brodowicz T; TURANDOT investigators. Bevacizumab plus paclitaxel versus bevacizumab plus capecitabine as first-line treatment for HER2-negative metastatic breast cancer (TURANDOT): primary endpoint results of a randomised, open-label, non-inferiority, phase 3 trial. Lancet Oncol. 2016 Sep;17(9):1230-9. doi: 10.1016/S1470-2045(16)30154-1. Epub 2016 Aug 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab Plus Paclitaxel | Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks |
| FG001 | Bevacizumab Plus Capecitabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bevacizumab and Capecitabine | Biological | B:Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks |
|
| Best Overall Response (ITT Population) |
The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase |
| Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
| Best Overall Response (PP Population) | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
| Unconfirmed Best Overall Response (ITT Population) | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment. | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
| Unconfirmed Best Overall Response (PP Population) | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment. | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
| Objective Response Rate and Disease Control Rate (ITT Population) | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
| Objective Response Rate and Disease Control Rate (PP Population) | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
| Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population) | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment. | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
| Unconfirmed Objective Response Rate and Disease Control Rate (PP Population) | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
| Progression Free Survival (ITT Population) | Progression Free Survival (PFS) is defined as time from randomization to date of documented progression or date of death due to any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients who were randomized and had no post-baseline tumor assessment were censored on the day of randomization. Median PFS, associated stratified Hazard Ratio (HR). | Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years. |
| Progression Free Survival (PP Population) | Progression Free Survival (PFS) is defined as time from randomization to date of documented progression or date of death due to any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients who were randomized and had no post-baseline tumor assessment were censored on the day of randomization. Median PFS, associated stratified Hazard Ratio (HR). | Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years. |
| Time to Treatment Failure (ITT Population) | Time to treatment failure (TTF) was defined as time from first drug intake to progression, death or withdrawal from study treatment, whichever occurred first. Patients without an event were censored at the date of the last tumor assessment or last treatment administration, whichever occurred last. Median TTF, associated stratified Hazard Ratio (HR). | From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years |
| Time to Treatment Failure (PP Population) | Time to treatment failure (TTF) was defined as time from first drug intake to progression, death or withdrawal from study treatment, whichever occurred first. Patients without an event were censored at the date of the last tumor assessment or last treatment administration, whichever occurred last. Median TTF, associated stratified Hazard Ratio (HR). | From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years |
| Time to Response (ITT Population) | Time to response (TR) was defined as time from randomization until occurrence of response (complete response (CR) or partial response (PR)) according to RECIST criteria. Patients without response were censored after the longest time to response observed in any patient. Median TR, associated stratified Hazard Ratio (HR). Since the median TR was not observed, the number of subjects with a response at given timepoints were reported. | Time from randomization until occurrence of response, assessed up 1.7 years |
| Time to Response (PP Population) | Time to response (TR) was defined as time from randomization until occurrence of response (complete response (CR) or partial response (PR)) according to RECIST criteria. Patients without response were censored after the longest time to response observed in any patient. Median TR, associated stratified Hazard Ratio (HR). Since the median TR was not observed, the number of subjects with a response at given timepoints were reported. | Time from randomization until occurrence of response, assessed up 1.7 years |
| Duration of Response (ITT Population) | Duration of response (DR) was defined as time from date of first occurrence of any response (complete response (CR) or partial response (PR)) until the occurrence of progression of disease or death. Patients with response who neither progressed nor died were censored at the date of their last tumor assessment. Median DR, associated stratified Hazard Ratio (HR). | Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response. |
| Duration of Response (PP Population) | Duration of response (DR) was defined as time from date of first occurrence of any response (complete response (CR) or partial response (PR)) until the occurrence of progression of disease or death. Patients with response who neither progressed nor died were censored at the date of their last tumor assessment. Median DR, associated stratified Hazard Ratio (HR). | Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response. |
| Linz |
| 4010 |
| Austria |
| AKH Linz, Dep. of Oncology | Linz | 4020 | Austria |
| Hospital Elisabethinen Linz | Linz | 4020 | Austria |
| Univ. Klinik, Medicine III | Salzburg | 5020 | Austria |
| 2. Med. Abteilung - LKH-Steyr | Steyr | 4400 | Austria |
| General Hospital, Medical University of Vienna | Vienna | 1090 | Austria |
| Hospital Hietzing | Vienna | 1130 | Austria |
| Institute of Oncology Sarajevo | Sarajevo | Bosnia and Herzegovina |
| Cancer Center Plovdiv | Plovdiv | 4000 | Bulgaria |
| University Hospital "Queen Joanna" | Sofia | 1527 | Bulgaria |
| Interdistrict Oncology Dispensary | Varna | Bulgaria |
| Department for Oncology, GH Osijek | Osijek | 31000 | Croatia |
| General Hospital Pula | Pula | 52100 | Croatia |
| University Hospital Centre Rijeka | Rijeka | 51000 | Croatia |
| University Hospital for Tumors | Zagreb | Croatia |
| University Hospital Rebro | Zagreb | Croatia |
| Krajska nemocnice Liberec | Liberec | 460 63 | Czechia |
| Institut onkologie a rehablilitace na Plesi | Nová Ves pod Plešà | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 77520 | Czechia |
| Charles University Prague, Dep of Oncology | Prague | Czechia |
| Semmelweis Univ. Radiology Clinic | Budapest | 1082 | Hungary |
| National Institute of Oncology | Budapest | 1122 | Hungary |
| Onkotherápiás Klinika, | Szeged | Hungary |
| Markusovszky Teaching Hospital | Szombathely | 9700 | Hungary |
| Meir Medical Center | Kfar Saba | Israel |
| Rabin Medical Center | Petah Tikva | Israel |
| Assuta Medical Center | Tel Aviv | Israel |
| Tel Aviv Sourasky Medical Center, Div of Oncology | Tel Aviv | Israel |
| Sheba Medical Center | Tel Litwinsky | Israel |
| P. Stradins University Hospital | Riga | 1020 | Latvia |
| Riga Eastern Hospital - the latvian Center of Oncology | Riga | 1079 | Latvia |
| Wojewodzkie Centrum Onkologii | Gdansk | 80-210 | Poland |
| Medical University of Gdansk | Gdansk | 80-211 | Poland |
| Klinika Onkologii CMuJ | Krakow | 31-501 | Poland |
| Lodz Oncology Center | Lodz | 93-503 | Poland |
| Centrum Medyczne Poradnia Onkologiczna | Rzeszów | 35-021 | Poland |
| Wojewodzki Szpital Specialistyczny | Siedlce | 08-110 | Poland |
| Szpital Wojewodzki im Sw. Lukasza | Tarnów | 33-100 | Poland |
| Memorial Cancer Center and Institute | Warsaw | 02-781 | Poland |
| Dolnoslaskie Centrum Onkologii | Wroclaw | 53-413 | Poland |
| Emergency University Bucharest Hospital | Bucharest | Romania |
| Institutul Oncologic Bucuresti | Bucharest | Romania |
| Cancer Institute "I. Chiricuta" | Cluj-Napoca | 400015 | Romania |
| University Hospital St. Spiridon Iasi | Iași | 700111 | Romania |
| Clinical County Hospital Sibiu | Sibiu | 550003 | Romania |
| Oncomed-Oncology Practice | Timișoara | 300239 | Romania |
| Institute for Oncology and Radiology | Belgrade | 11000 | Serbia |
| Clinical Hospital Center " Bezanijska Kosa" | Belgrade | 11080 | Serbia |
| Institute of Oncology | Kamenitz | 21204 | Serbia |
| Clinic of Oncology | Niš | 18000 | Serbia |
| Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav | Bratislava | 81250 | Slovakia |
| National Cancer Institute | Bratislava | 83310 | Slovakia |
| Oncology Institute, Department of Radiotherapy and Onclogy | Košice | 04191 | Slovakia |
| POKO Porad, s.r.o | Poprad | 05801 | Slovakia |
| 25268370 | Derived | Brodowicz T, Lang I, Kahan Z, Greil R, Beslija S, Stemmer SM, Kaufman B, Petruzelka L, Eniu A, Anghel R, Koynov K, Vrbanec D, Pienkowski T, Melichar B, Spanik S, Ahlers S, Messinger D, Inbar MJ, Zielinski C. Selecting first-line bevacizumab-containing therapy for advanced breast cancer: TURANDOT risk factor analyses. Br J Cancer. 2014 Nov 25;111(11):2051-7. doi: 10.1038/bjc.2014.504. Epub 2014 Sep 30. |
| 23312888 | Derived | Lang I, Brodowicz T, Ryvo L, Kahan Z, Greil R, Beslija S, Stemmer SM, Kaufman B, Zvirbule Z, Steger GG, Melichar B, Pienkowski T, Sirbu D, Messinger D, Zielinski C; Central European Cooperative Oncology Group. Bevacizumab plus paclitaxel versus bevacizumab plus capecitabine as first-line treatment for HER2-negative metastatic breast cancer: interim efficacy results of the randomised, open-label, non-inferiority, phase 3 TURANDOT trial. Lancet Oncol. 2013 Feb;14(2):125-33. doi: 10.1016/S1470-2045(12)70566-1. Epub 2013 Jan 10. |
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks
| COMPLETED |
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| NOT COMPLETED |
|
Intention-to-Treat Population (ITT)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab Plus Paclitaxel | Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks |
| BG001 | Bevacizumab Plus Capecitabine | Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Menopausal status | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | 0 - Asymptomatic, 1 - Symptomatic but completely ambulatory, 2 - Symptomatic, <50% in bed during the day, 3 - Symptomatic, >50% in bed, but not bedbound, 4 - Bedbound, 5 - Death | Count of Participants | Participants |
| |||||||||||||||
| Estrogen receptor (ER) | Count of Participants | Participants |
| ||||||||||||||||
| Progesterone Receptor (PgR) | Count of Participants | Participants |
| ||||||||||||||||
| Estrogen and progesterone receptor | Count of Participants | Participants |
| ||||||||||||||||
| Electrocardiogram (ECG) result | Count of Participants | Participants |
| ||||||||||||||||
| Method for brain imaging | No brain CT or MRI was required if the patient did not show signs/symptoms of central nervous system (CNS) involvement or other unexplained neurological symptoms. | Count of Participants | Participants |
| |||||||||||||||
| Result of brain CT/MRI | No brain CT or MRI was required if the patient did not show signs/symptoms suggestive of CNS involvement or other unexplained neurological symptoms. | Count of Participants | Participants |
| |||||||||||||||
| Stage at primary diagnosis: Primary tumor (T) | Tis - Ductal carcinoma in situ, TX - Primary Tumor cannot be assessed, T1 - Tumor ≤ 20 mm in greatest dimension, T2 - Tumor > 20 mm but ≤ 50 mm in greatest dimension, T3 - Tumor > 50 mm in greatest dimension, T4 - Tumor of any size with direct extension to chest wall and/or to skin (ulceration or macroscopic nodules). | Count of Participants | Participants |
| |||||||||||||||
| Stage at primary diagnosis: Regional lymph nodes (N) | Nx - Regional lymph nodes cannot be assessed, N0 - No regional lymph node metastases, N1 - Metastases to movable ipsilateral level I, II axillary lymph nodes, N2 - Metastases in ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted; or in clinically detected ipsilateral internal mammary nodes in absence of clinically evident axillary lymph node metastases, N3 - Metastases in ipsilateral infraclavicular (level III axillary) lymph nodes with or without level I, II axillary lymph node involvement. | Count of Participants | Participants |
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| Stage at primary diagnosis: Distant metastasis (M) | M0 - No clinical or radiographic evidence of distant metastases, M1 - Distant metastases detected, Mx - Metastases cannot be assessed. | Count of Participants | Participants |
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| Current stage of locally recurrent/ metastatic tumor | Count of Participants | Participants |
| ||||||||||||||||
| Disease free interval after therapy of primary breast cancer | Count of Participants | Participants |
| ||||||||||||||||
| Disease free interval | Disease free interval set to 0 months (No DFI), if the patient did not receive previous therapy for primary breast cancer or if the patient was not disease free after previous therapy of primary breast cancer | Count of Participants | Participants |
| |||||||||||||||
| Metastatic lesions | All sites with at least one metastatic lesion. Patients can have multiple sites with metastatic lesions. | Count of Participants | Participants |
| |||||||||||||||
| Imaging methods | Count of Participants | Participants |
| ||||||||||||||||
| Target and non-target lesions | Count of Participants | Participants |
| ||||||||||||||||
| Number of target lesions | Count of Participants | Participants |
| ||||||||||||||||
| Sum of longest diameter of target lesion | Count of Participants | Participants |
| ||||||||||||||||
| Number of organs with metastases | Count of Participants | Participants |
| ||||||||||||||||
| Previous hormonal therapy | LR/MBC = for locally recurrent / metastatic breast cancer | Count of Participants | Participants |
| |||||||||||||||
| Neoadjuvant/ adjuvant hormonal therapy only | Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible. | Count of Participants | Participants |
| |||||||||||||||
| Hormonal therapy for LR/MBC only | Only participants with hormonal therapy for LR/ MBC included. Multiple answers per patient possible. | Count of Participants | Participants |
| |||||||||||||||
| Previous neoadjuvant chemotherapy | Count of Participants | Participants |
| ||||||||||||||||
| Previous adjuvant chemotherapy | Count of Participants | Participants |
| ||||||||||||||||
| Previous neoadjuvant/adjuvant chemotherapy | Patients for whom their neoadjuvant and adjuvant chemotherapy differed are counted in both the pertinent categories. | Count of Participants | Participants |
| |||||||||||||||
| Previous neoadjuvant/adjuvant chemotherapy medications | Patients who received both anthracycline and taxane in an adjuvant or neoadjuvant chemotherapy are counted in both categories. | Count of Participants | Participants |
| |||||||||||||||
| Previous radiotherapy | Multiple answers per patient possible. In case of multiple treatments in the same category, the patient is counted only once in that category. | Restricted to patients with previous radiotherapy. | Count of Participants | Participants |
| ||||||||||||||
| Previous surgery | Multiple answers per patient possible. In case of multiple treatments in the same category, the patient is counted only once in that category. | Restricted to patients with previous surgery. | Count of Participants | Participants |
| ||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body Surface Area (BSA) | Mean | Standard Deviation | m² |
| |||||||||||||||
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Heart rate | Mean | Standard Deviation | bpm |
| |||||||||||||||
| Body temperature | Mean | Standard Deviation | °C |
| |||||||||||||||
| Left Ventricular Ejection Fraction (LVEF) | Mean | Standard Deviation | percentage of ejected blood |
| |||||||||||||||
| Time since diagnosis of adenocarcinoma | Histologically or cytologically confirmed adenocarcinoma. | Mean | Standard Deviation | months |
| ||||||||||||||
| Time since diagnosis of LR or MT | LR or MT = Locally recurrent or metastatic tumor. | Mean | Standard Deviation | months |
| ||||||||||||||
| Disease free interval | Disease free interval was set to 0 months (No DFI) if the patient did not receive previous therapy for primary breast cancer or the patient was not disease free after previous therapy for primary breast cancer. | Mean | Standard Deviation | months |
| ||||||||||||||
| Number of target lesions | Mean | Standard Deviation | number of lesions |
| |||||||||||||||
| Sum of longest diameter of target lesions | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 | Overall Survival (PP Population) | Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250. | Per Protocol Population (PP) | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival (ITT Population) | Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 50% of information was 0.0014. Alpha spent at final analysis after 99% of information was 0.0250. | Intent-to-Treat Population (ITT) | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years |
|
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| Secondary | Observation Time (ITT Population) | Median observation time estimated with reverse Kaplan-Meier methods. Observation time (in months) is defined as time from randomization to the day the patient was last confirmed to be alive. In case of patient deaths the time was censored at the day of death. | Intention-to-Treat population | Posted | Median | 95% Confidence Interval | months | Up to approximately 6 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response (ITT Population) | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase | Intent-to-Treat population | Posted | Count of Participants | Participants | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response (PP Population) | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase | Per protocol population | Posted | Count of Participants | Participants | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unconfirmed Best Overall Response (ITT Population) | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment. | ITT population | Posted | Count of Participants | Participants | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unconfirmed Best Overall Response (PP Population) | The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment. | PP population | Posted | Count of Participants | Participants | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate and Disease Control Rate (ITT Population) | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase | ITT population | Posted | Count of Participants | Participants | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate and Disease Control Rate (PP Population) | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase | PP population | Posted | Count of Participants | Participants | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population) | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment. | ITT population | Posted | Count of Participants | Participants | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unconfirmed Objective Response Rate and Disease Control Rate (PP Population) | Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment | PP population | Posted | Count of Participants | Participants | Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (ITT Population) | Progression Free Survival (PFS) is defined as time from randomization to date of documented progression or date of death due to any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients who were randomized and had no post-baseline tumor assessment were censored on the day of randomization. Median PFS, associated stratified Hazard Ratio (HR). | ITT population | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PP Population) | Progression Free Survival (PFS) is defined as time from randomization to date of documented progression or date of death due to any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients who were randomized and had no post-baseline tumor assessment were censored on the day of randomization. Median PFS, associated stratified Hazard Ratio (HR). | PP population | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure (ITT Population) | Time to treatment failure (TTF) was defined as time from first drug intake to progression, death or withdrawal from study treatment, whichever occurred first. Patients without an event were censored at the date of the last tumor assessment or last treatment administration, whichever occurred last. Median TTF, associated stratified Hazard Ratio (HR). | ITT population | Posted | Median | 95% Confidence Interval | months | From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure (PP Population) | Time to treatment failure (TTF) was defined as time from first drug intake to progression, death or withdrawal from study treatment, whichever occurred first. Patients without an event were censored at the date of the last tumor assessment or last treatment administration, whichever occurred last. Median TTF, associated stratified Hazard Ratio (HR). | PP population | Posted | Median | 95% Confidence Interval | months | From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (ITT Population) | Time to response (TR) was defined as time from randomization until occurrence of response (complete response (CR) or partial response (PR)) according to RECIST criteria. Patients without response were censored after the longest time to response observed in any patient. Median TR, associated stratified Hazard Ratio (HR). Since the median TR was not observed, the number of subjects with a response at given timepoints were reported. | ITT population, median not reached | Posted | Count of Participants | Participants | Time from randomization until occurrence of response, assessed up 1.7 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (PP Population) | Time to response (TR) was defined as time from randomization until occurrence of response (complete response (CR) or partial response (PR)) according to RECIST criteria. Patients without response were censored after the longest time to response observed in any patient. Median TR, associated stratified Hazard Ratio (HR). Since the median TR was not observed, the number of subjects with a response at given timepoints were reported. | PP population, median not reached | Posted | Count of Participants | Participants | Time from randomization until occurrence of response, assessed up 1.7 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (ITT Population) | Duration of response (DR) was defined as time from date of first occurrence of any response (complete response (CR) or partial response (PR)) until the occurrence of progression of disease or death. Patients with response who neither progressed nor died were censored at the date of their last tumor assessment. Median DR, associated stratified Hazard Ratio (HR). | ITT population restricted to patients who experienced a partial or complete response | Posted | Median | 95% Confidence Interval | months | Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (PP Population) | Duration of response (DR) was defined as time from date of first occurrence of any response (complete response (CR) or partial response (PR)) until the occurrence of progression of disease or death. Patients with response who neither progressed nor died were censored at the date of their last tumor assessment. Median DR, associated stratified Hazard Ratio (HR). | PP population restricted to patients who experienced a partial or complete response | Posted | Median | 95% Confidence Interval | months | Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response. |
|
|
From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized.
1 patient in Arm A and 2 patients in Arm B were not treated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab Plus Paclitaxel | Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks | 196 | 284 | 65 | 284 | 264 | 284 |
| EG001 | Bevacizumab Plus Capecitabine | Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks | 209 | 277 | 68 | 277 | 240 | 277 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Systolic dysfunction | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Brain hypoxia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nerve root compression | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hallucination, olfactory | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Breast lump removal | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Catheterisation venous | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MD. Christiane Thallinger | CECOG | +43 1 409 77 25 | office@cecog.at |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Latvia |
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| Romania |
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| Hungary |
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| Czechia |
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| Poland |
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| Slovakia |
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| Israel |
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| Bulgaria |
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| Serbia |
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| Bosnia and Herzegovina |
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| Croatia |
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| Bone |
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| Lung |
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| Liver |
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| Skin |
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| Soft tissue |
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| Lymph nodes |
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| Other |
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| Lung and / or liver |
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| Soft tissue and/or bone only |
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| Aromatase inhibitors |
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| LR-RH analogues |
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| Progesterone |
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| Other |
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| Aromatase inhibitors |
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| LH-RH analogues |
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| Anthracycline, no taxane |
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| Taxane, no anthracycline |
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| No anthracycline, no taxane, other |
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| None |
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| Taxane |
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| No anthracycline, no taxane, other |
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| None |
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| Adjuvant |
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| For relief of metastatic bone pain |
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| Breast conserving surgery |
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| Biopsy/Aspiration |
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| Other |
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| HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified). | Regression, Cox | 0.0070 | Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33. | Hazard Ratio (HR) | 1.018 | 1-Sided | 97.5 | 1.261 | HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel. | Non-Inferiority | Null hypothesis: Hazard Ratio (HR) >= 1.33 Based on Cox proportional hazards model adjusted by stratification factors at randomization:
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| HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified). | Regression, Cox | 0.2024 | Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33. | Hazard Ratio (HR) | 1.058 | 1-Sided | 97.5 | 1.674 | HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel. | Non-Inferiority | Null hypothesis: Hazard Ratio (HR) >= 1.33 Based on Cox proportional hazards model. |
| HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified). | Regression, Cox | 0.0612 | Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33. | Hazard Ratio (HR) | 1.134 | 1-Sided | 97.5 | 1.386 | HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel. | Non-Inferiority | Null hypothesis: Hazard Ratio (HR) >= 1.33 Based on Cox proportional hazards model. |
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