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| Name | Class |
|---|---|
| Eisai Co., Ltd. | INDUSTRY |
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To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent HER2-positive breast cancer patients who have no medical history of chemotherapy except ado-trastuzumab emtansine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Trastuzumab + pertuzumab + Taxane* *Taxane is chosen from the following; Docetaxel or Paclitaxel |
|
| Arm B | Experimental | Trastuzumab+ Pertuzumab + Eribulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertuzumab | Drug | Every 3 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival | 5.75 years |
| Measure | Description | Time Frame |
|---|---|---|
| RR | Response rate | 5.75 years |
| DR | Duration of response | 5.75 years |
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Inclusion Criteria:
(1) Neutrophil count: >=1,500/mm3 (2) Platelet count: >=100,000/mm 3 (3) Hemoglobin: >=9.0 g/dL (4) Total bilirubin: <=1.5 mg/dL (5) AST (GOT), ALT (GPT): <=2.5 times the ULN (<=5 times in those with liver metastasis) (6) Serum creatinine: <=1.5 mg/dL 10) Patients with a life expectancy of at least 6 months 11) Patient who submits written consent herself after receiving sufficient explanation about this study 12) Patients who can undergo QOL investigation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshinari Tamashita, MD, PhD | Kanagawa Cancer Center | Principal Investigator |
| Norikazu Masuda, MD, PhD | NHO Osaka National Hospital | Principal Investigator |
| Shigehira Saji, MD, PhD | Fukushima Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan | ||
| National Hospital Organization Osaka National Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22149875 | Result | Baselga J, Cortes J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. doi: 10.1056/NEJMoa1113216. Epub 2011 Dec 7. | |
| 21376385 | Result |
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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 |
|---|---|
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| C490954 | eribulin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Trastuzumab | Drug | Every 3 weeks |
|
|
| Docetaxel | Drug | Every 3 weeks |
|
|
| Paclitaxel | Drug | Every week |
|
|
| Eribulin | Drug | Administered for 2 weeks and is then stopped to be administered for 1 week |
|
|
| OS |
Overall survival |
| 6.25 years |
| PRO | Patient-reported outcomes(Numbness & tingling) | 5.75 years |
| Safety |
| 5.75 years |
| Biomaker | DNA mutation in the ctDNA and tumor tissue such as HER2,HER3, and PIK3CA | 5.75 years |
| nMFS | new Metastases free survival | 5.75 years |
| TTF of the subsequent treatment | Treatment duration of the following treatment | 5.75 years |
| Osaka |
| Osaka |
| 540-0006 |
| Japan |
| Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2. |
| 25605862 | Result | Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20. |
| 25024001 | Result | Wilks S, Puhalla S, O'Shaughnessy J, Schwartzberg L, Berrak E, Song J, Cox D, Vahdat L. Phase 2, multicenter, single-arm study of eribulin mesylate with trastuzumab as first-line therapy for locally recurrent or metastatic HER2-positive breast cancer. Clin Breast Cancer. 2014 Dec;14(6):405-12. doi: 10.1016/j.clbc.2014.04.004. Epub 2014 Jun 2. |
| 42420599 | Derived | Masuda N, Saji S, Kojima Y, Kitada M, Tada H, Iwasa T, Koizumi K, Iwatani T, Sagara Y, Kuwayama T, Shimoda M, Sasada T, Tsugawa K, Kawaguchi Y, Shimomura A, Yamaguchi T, Hasegawa H, Osaka S, Morita S, Yamashita T. Efficacy and safety of eribulin mesylate vs. docetaxel or paclitaxel, combined with trastuzumab and pertuzumab, as first-line treatment for HER2-positive locally advanced or metastatic breast cancer: updated subgroup analyses of JBCRG-M06/EMERALD. Breast Cancer Res Treat. 2026 Jul 8;218(1):3. doi: 10.1007/s10549-026-08004-5. |
| 39787453 | Derived | Yamashita T, Saji S, Takano T, Naito Y, Tsuneizumi M, Yoshimura A, Takahashi M, Tsurutani J, Iwatani T, Kitada M, Tada H, Mori N, Higuchi T, Iwasa T, Araki K, Koizumi K, Hasegawa H, Uchida Y, Morita S, Masuda N. Trastuzumab-Pertuzumab Plus Eribulin or Taxane as First-Line Chemotherapy for Human Epidermal Growth Factor 2-Positive Locally Advanced/Metastatic Breast Cancer: The Randomized Noninferiority Phase III EMERALD Trial. J Clin Oncol. 2025 Apr 10;43(11):1302-1313. doi: 10.1200/JCO-24-01888. Epub 2025 Jan 9. |
| 32381018 | Derived | Yamashita T, Masuda N, Saji S, Araki K, Ito Y, Takano T, Takahashi M, Tsurutani J, Koizumi K, Kitada M, Kojima Y, Sagara Y, Tada H, Iwasa T, Kadoya T, Iwatani T, Hasegawa H, Morita S, Ohno S. Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD). Trials. 2020 May 7;21(1):391. doi: 10.1186/s13063-020-04341-y. |
| D017437 |
| Skin and Connective Tissue Diseases |
| 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 |