Unique ID issued by UMIN | UMIN000012179 |
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Receipt number | R000014038 |
Scientific Title | Bevacizumab plus paclitaxel optimization study with interventional maintenance endocrine therapy in advanced or metastatic ER-positive HER2-negative breast cancer-BOOSTER trial, a multicenter randomized phase II study |
Date of disclosure of the study information | 2013/10/31 |
Last modified on | 2022/07/16 20:17:56 |
Bevacizumab plus paclitaxel optimization study with interventional maintenance endocrine therapy in advanced or metastatic ER-positive HER2-negative breast cancer-BOOSTER trial, a multicenter randomized phase II study
JBCRG-M04 (BOOSTER)
Bevacizumab plus paclitaxel optimization study with interventional maintenance endocrine therapy in advanced or metastatic ER-positive HER2-negative breast cancer-BOOSTER trial, a multicenter randomized phase II study
JBCRG-M04 (BOOSTER)
Japan |
Hormone receptor positive, HER2 negative advanced or recurrence (metastatic) breast cancer
Hematology and clinical oncology | Surgery in general | Breast surgery |
Malignancy
YES
To compare continuing bevacizumab + paclitaxel or switching to bevacizumab + endocrine maintenance therapy followed by bevacizumab + paclitaxel, after 1st line induction therapy with bevacizumab + paclitaxel in
ER+HER2- advanced or metastatic breast cancer.
Safety,Efficacy
Exploratory
Explanatory
Phase II
Time to failure of strategy (TFS)
2y Overall Survival rate, Overall Survival, Progression Free Survival: PFS, QOL, Biomarker, Safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
weekly paclitaxel + bevacizumab
endocrine therapy + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
20 | years-old | <= |
75 | years-old | >= |
Female
1. Histologically confirmed adenocarcinoma of the breast
2. Female aged 20-75 years old at getting informed consent
3. HER2 negative disease (IHC 0/1+ or 2+ with FISH negative)
4. Documented estrogen receptor (ER) positive (>=1% by IHC)
5. Inoperative locally advanced or metastatic breast cancer at enrolment
6. Performance status (ECOG): 0-1 at enrolment
7. Life expectancy of at least 3 months from enrolment
8. No prior systemic therapy for recurrent breast cancer (excluding hormone therapy)
9. No prior neo and/or adjuvant chemotherapy with taxane or adjuvant setting with a disease-free interval from completion of the taxane treatment to metastatic diagnosis of >= 12 months
10. Patients with measurable lesion regarding with RECIST criteria or who have evaluable lesion
11. Patients with only bone lesion will be acceptable if the osteolytic lesion has a measurable soft tissue component by MRI or CT
12. No influence on protocol treatment is considered in case prior therapy or examination.
13. Adequate following organ function within 2 weeks before starting treatment. The latest examination results should be adopted and blood transfusion or treatment of hematopoietic factor drugs is not allowed 2 weeks before examination.
- Absolute neutrophil count >= 1500 /mm3 or WBC count >= 3000 /mm3
- Platelets >=10 x 10000 /mm3
- Hb >= 9 g/dL
- Total bilirubin <= 1.5 mg/dL(except for constitutional jaundice)
- AST and ALT <= 100IU/L (<=200IU/L if liver metastasis)
- Serum creatinine <= 1.5 mg/dL
-Urine dipstick for proteinuria <= 1+
14. Written informed consent signed by patients before completing any treatment related procedure
(1)Prior therapy with bevacizumab
(2) Active infection requiring intrvenous antibiotics at enrollment or infection with active HBV and/or HCV.
(3) Pregnancy, lactetion or in case of potentialy pregnancy women Not mind contraception in trial period.
(4) Known hypersensitivity to bevacizumab or paclitaxel
(5) History of hemoptysis (>= 2.5mL of bright red blood per episord).
(6) Use of disulfiram,cyanamide, carmofur or procarbazine Hydrochloride
(7) Patients with CNS metastases (except for not symptomatic)
(8) Persistent Grade >= 2 sensory neuropathy at enrollment
(9) Grade 3 >= hypertension (>= 2 use of antihypertensive drug)
10) Evidence with arterial thromboembolism
(Cerebral infarction, Myocardial infarction) or history within 1 year prior to enrollment.
(11) Evidence withvenous thromboembolism (deep vein thrombosis, pulmonary embolism) or history within 1 year prior to enrollment.
(12) History of GI perforation and/or serious abdominal fistula within 1 year prior to enrollment
(13) Cases that the investigator judged as inappropriate as the subject of this clinical study
160
1st name | 1)Shigehira, 2)Masakazu |
Middle name | |
Last name | 1)Saji, 2)Toi |
1) Fukushima Medical University
2) Kyoto University Graduate School of Medicine
1) Department of Medical Oncology, 2) Department of Breast Surgery
1)960-1295,2)606-8507
1) 1 Hikariga-oka, Fukushima City, 960-1295 JAPAN, 2) 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
024-547-1511
ss-saji@wa2.so-net.ne.jp
1st name | Jun |
Middle name | |
Last name | Fukase |
Japan Breast Cancer Research Group (JBCRG)
Head office
103-0016
3rd Floor, Nihonbashikoamicho9-4, Chuo-ku, Tokyo 103-0016, JAPAN
03-6264-8873
https://www.jbcrg.jp/
office@jbcrg.jp
Japan Breast Cancer Research Group (JBCRG)
Chugai Pharmaceutical Co., Ltd.
Profit organization
Japan
Fukushima Medical University Certified Review Board
1 Hikariga-oka, Fukushima City, 960-1295 JAPAN
024-547-1825
fmucrb@fmu.ac.jp
YES
NCT01989780
ClinicalTrials.gov
公立大学法人福島県立医科大学附属病院(福島県)、弘前市立病院(青森県)、久留米大学病院(福岡県)、京都大学医学部附属病院(京都府)、国家公務員共済組合連合会虎の門病院(東京都)、埼玉県立がんセンター(埼玉県)、愛知県がんセンター(愛知県)、横浜市立大学附属市民総合医療センター(神奈川県)、北海道大学病院(北海道)、北村山公立病院(山形県)、独立行政法人国立病院機構九州がんセンター(福岡県)、国立病院機構 長崎医療センター(長崎県)、広島市立広島市民病院(広島県)、札幌医科大学附属病院(北海道)、群馬県立がんセンター(群馬県)、東北大学病院(宮城県)、日本赤十字社和歌山医療センター(和歌山県)、旭川医科大学病院(北海道)、東京都立駒込病院(東京都)、宮崎県立宮崎病院(宮崎県)、独立行政法人国立病院機構四国がんセンター(愛媛県)、兵庫県立がんセンター(兵庫県)、国立病院機構呉医療センター中国がんセンター(広島県)、熊本大学病院(熊本県)、浜松医療センター(静岡県)、東京医科大学病院(東京都)、山形県立中央病院(山形県)、神戸市立医療センター中央市民病院(兵庫県)、独立行政法人地域医療機能推進機構 下関医療センター(山口県)、小牧市民病院(愛知県)、名古屋市立大学病院(愛知県)、静岡県立総合病院(静岡県)、岡山大学病院(岡山県)、東京医科大学八王子医療センター(東京都)、市立四日市病院(三重県)、国立大学法人岐阜大学医学部附属病院(岐阜県)、佐賀県医療センター好生館(佐賀県)、名古屋大学医学部附属病院(愛知県)、関西電力病院(大阪府)、国立病院機構 北海道がんセンター(北海道)、千葉県がんセンター(千葉県)、岩手医科大学附属病院(岩手県)、大崎市民病院(宮城県)、筑波大学附属病院(茨城県)、福山市民病院(広島県)、日本海総合病院(山形県)、熊本赤十字病院(熊本県)、聖マリアンナ医科大学病院(神奈川県)、JA広島総合病院(広島県)、岐阜市民病院(岐阜県)、伊勢崎市民病院(群馬県)、独立行政法人 国立病院機構 埼玉病院(埼玉県)、順天堂大学医学部附属順天堂医院(東京都)
2013 | Year | 10 | Month | 31 | Day |
https://jrct.niph.go.jp/latest-detail/jRCTs021180026
Published
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00196-6/fulltext
160
Median TFS (time-to-failure of strategy) are 8.87 months in the wPTX + BV continued group, and 16.82 months in the maintenance endocrine + BV group, respectively (HR 0.51; p<0.001).
OS (overall survival) in both groups are similar, which means chemo-holiday with endocrine based therapy could be safely applied to ER+HER2-ABC/MBC after induction chemotherapy.
HRQoL seems to be better in endocrine + BV compared to chemotherapy continuous strategy.
2022 | Year | 07 | Month | 14 | Day |
2022 | Year | 04 | Month | 08 | Day |
wPTX + BV continue: 63 Age( mean 56.2 ) Menopause( Pre: 33.3%, Post: 63.5% ) PS( 0:81.0%, 1:19.0% )
endocrine + BV maintenance: 61 Age( mean 56.2 ) Menopause ( Pre:27.9%, Post:70.5% ) PS( 0:91.8%, 1:8.2% )
Following 4 to 6 cycles of paclitaxel + bevacizumab (wPTX + BV) therapy for ER-positive HER2-negative advanced/recurrent breast cancer (n=160), patients who responded to this therapy were randomized (n=125). 63 cases were in wPTX + BV continuous treatment group, and 62 cases were in endocrine + BV therapy switch group. Except for one unknown record case, all patients had protocol treatment.
The number and rate of major adverse events by group and grades are reported below.
1. All adverse events
(1) wPTX+BV therapy (63 patients)
All grade:59(93.7%) Grade3:50(79.4%) Grade4:5(7.9%)
(2) endocrine + BV therapy (61 patients)
All grade:51(83.6%) Grade3:35(57.4%) Grade4:5(8.2%)
(3) All (124 patients)
All grade:110(88.7%) Grade3:85(68.5%) Grade4:10(8.1%)
2. Hyper tension
(1) wPTX+BV therapy (63 patients)
All grade:39(61.9%) Grade3:24(38.1%) Grade4:1(1.6%)
(2) endocrine + BV therapy (61 patients)
All grade:38(62.3%) Grade3:20(32.8%) Grade4:2(3.3%)
(3) All (124 patients)
All grade:77(62.1%) Grade3:44(35.5%) Grade4:3(2.4%)
3. Decrease in neutrophil count
(1) wPTX+BV therapy (63 patients)
All grade:33(52.4%) Grade3:16(25.4%) Grade4:2(3.2%)
(2) endocrine + BV therapy (61 patients)
All grade:26(42.6%) Grade3:10(16.4%) Grade4:2(3.3%)
(3) All (124 patients)
All grade:59(47.6%) Grade3:26(21.0%) Grade4:4(3.2%)
4. Peripheral neuropathy
(1) wPTX+BV therapy (63 patients)
All grade:50(79.4%) Grade3:17(27.0%) Grade4:0(0.0%)
(2) endocrine + BV therapy (61 patients)
All grade:34(55.7%) Grade3:5(8.2%) Grade4:0(0.0%)
(3) All (124 patients)
All grade:84(67.7%) Grade3:22(17.7%) Grade4:0(0.0%)
5. Proteinuria
(1) wPTX+BV therapy (63 patients)
All grade:26(41.3%) Grade3:10(15.9%) Grade4:0(0.0%)
(2) endocrine + BV therapy (61 patients)
All grade:28(45.9%) Grade3:13(21.3%) Grade4:0(0.0%)
(3) All (124 patients)
All grade:54(43.5%) Grade3:23(18.5%) Grade4:0(0.0%)
6. Bleeding
(1) wPTX+BV therapy (63 patients)
All grade:19(30.2%) Grade3:0(0.0%) Grade4:0(0.0%)
(2) endocrine + BV therapy (61 patients)
All grade:24(39.3%) Grade3:0(0.0%) Grade4:0(0.0%)
(3) All (124 patients)
All grade:43(34.7%) Grade3:0(0.0%) Grade4:0(0.0%)
(1)Primary endpoint: Time to failure of strategy(TFS)
Median TFS was 8.87 months in the wPTX + continued BV group and 16.82 months in the hormone + BV group. TFS was significantly prolonged in the hormone + BV group (HR 0.51; p<0.001).
(2)Secondary endpoint: Overall survival
There was no difference in OS between the wPTX + BV continuation group and the hormone + BV group.
(3)Secondary endpoint: HRQOL(Health-related QOL) FACT-B-TOI (improvement, deterioration)
HRQoL tended to be better in the hormone + BV therapy group compared to the wPTX + BV continuation group at 4 months and 1 year, although not significantly different.
Deidetified patient data will be made available upon reasonable request.
Main results already published
2012 | Year | 10 | Month | 27 | Day |
2013 | Year | 05 | Month | 25 | Day |
2014 | Year | 01 | Month | 28 | Day |
2019 | Year | 06 | Month | 30 | Day |
2019 | Year | 06 | Month | 30 | Day |
2019 | Year | 06 | Month | 30 | Day |
2013 | Year | 10 | Month | 31 | Day |
2022 | Year | 07 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014038
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