Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA)
Pertuzumab (P) combined with trastuzumab (H)-based chemotherapy improves efficacy in early and advanced HER2-positive breast cancer. We assessed the tolerability, with particular focus on cardiac safety, of H and P with chemotherapy in the neoadjuvant treatment of HER2-positive early breast cancer....
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| Veröffentlicht in: | Annals of oncology 2013-09, Vol.24 (9), p.2278-2284 |
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| creator | Schneeweiss, A. Chia, S. Hickish, T. Harvey, V. Eniu, A. Hegg, R. Tausch, C. Seo, J.H. Tsai, Y.-F. Ratnayake, J. McNally, V. Ross, G. Cortés, J. |
| description | Pertuzumab (P) combined with trastuzumab (H)-based chemotherapy improves efficacy in early and advanced HER2-positive breast cancer. We assessed the tolerability, with particular focus on cardiac safety, of H and P with chemotherapy in the neoadjuvant treatment of HER2-positive early breast cancer.
In this multicenter, open-label phase II study, patients with operable, locally advanced, or inflammatory breast cancer were randomized 1 : 1 : 1 to receive six neoadjuvant cycles q3w (Arm A: 5-fluorouracil, epirubicin, cyclophosphamide [FEC] + H + P ×3 → docetaxel [T] + H + P ×3; Arm B: FEC ×3 → T + H + P ×3; Arm C: T + carboplatin + H [TCH]+P ×6). pCR was assessed at surgery and adjuvant therapy given to complete 1 year of H.
Two hundred twenty-five patients were randomized. During neoadjuvant treatment, two patients (2.7%; Arm B) experienced symptomatic left ventricular systolic dysfunction (LVSD) and 11 patients (Arm A: 4 [5.6%]; Arm B: 4 [5.3%]; Arm C: 3 [3.9%]) had declines in left ventricular ejection fraction of ≥10% points from baseline to |
| doi_str_mv | 10.1093/annonc/mdt182 |
| format | Article |
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In this multicenter, open-label phase II study, patients with operable, locally advanced, or inflammatory breast cancer were randomized 1 : 1 : 1 to receive six neoadjuvant cycles q3w (Arm A: 5-fluorouracil, epirubicin, cyclophosphamide [FEC] + H + P ×3 → docetaxel [T] + H + P ×3; Arm B: FEC ×3 → T + H + P ×3; Arm C: T + carboplatin + H [TCH]+P ×6). pCR was assessed at surgery and adjuvant therapy given to complete 1 year of H.
Two hundred twenty-five patients were randomized. During neoadjuvant treatment, two patients (2.7%; Arm B) experienced symptomatic left ventricular systolic dysfunction (LVSD) and 11 patients (Arm A: 4 [5.6%]; Arm B: 4 [5.3%]; Arm C: 3 [3.9%]) had declines in left ventricular ejection fraction of ≥10% points from baseline to <50%. Diarrhea was the most common adverse event. pCR (ypT0/is) was reported for 61.6% (Arm A), 57.3% (Arm B), and 66.2% (Arm C) of patients.
The combination of P with H and standard chemotherapy resulted in low rates of symptomatic LVSD.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdt182</identifier><identifier>PMID: 23704196</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Anthracyclines - adverse effects ; Anthracyclines - therapeutic use ; Antibodies, Monoclonal, Humanized - adverse effects ; Antibodies, Monoclonal, Humanized - therapeutic use ; Antineoplastic agents ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Carboplatin - therapeutic use ; Cyclophosphamide - therapeutic use ; Docetaxel ; early breast cancer ; Epirubicin - therapeutic use ; Female ; Fluorouracil - therapeutic use ; Gynecology. Andrology. Obstetrics ; Heart - drug effects ; HER2 ; Humans ; Inflammatory Breast Neoplasms - drug therapy ; Inflammatory Breast Neoplasms - surgery ; LVSD ; Mammary gland diseases ; Medical sciences ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; neoadjuvant ; Neoadjuvant Therapy - methods ; pertuzumab ; Pharmacology. Drug treatments ; Receptor, ErbB-2 - antagonists & inhibitors ; Receptor, ErbB-2 - metabolism ; Stroke Volume - drug effects ; Taxoids - therapeutic use ; Trastuzumab ; Tumors ; Ventricular Function, Left - drug effects</subject><ispartof>Annals of oncology, 2013-09, Vol.24 (9), p.2278-2284</ispartof><rights>2013 European Society for Medical Oncology</rights><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c410t-a9105447ecb53b1c609bfe4848403cdcbc2704f914e8a748224ab095945485923</citedby><cites>FETCH-LOGICAL-c410t-a9105447ecb53b1c609bfe4848403cdcbc2704f914e8a748224ab095945485923</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27697270$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23704196$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Schneeweiss, A.</creatorcontrib><creatorcontrib>Chia, S.</creatorcontrib><creatorcontrib>Hickish, T.</creatorcontrib><creatorcontrib>Harvey, V.</creatorcontrib><creatorcontrib>Eniu, A.</creatorcontrib><creatorcontrib>Hegg, R.</creatorcontrib><creatorcontrib>Tausch, C.</creatorcontrib><creatorcontrib>Seo, J.H.</creatorcontrib><creatorcontrib>Tsai, Y.-F.</creatorcontrib><creatorcontrib>Ratnayake, J.</creatorcontrib><creatorcontrib>McNally, V.</creatorcontrib><creatorcontrib>Ross, G.</creatorcontrib><creatorcontrib>Cortés, J.</creatorcontrib><title>Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA)</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Pertuzumab (P) combined with trastuzumab (H)-based chemotherapy improves efficacy in early and advanced HER2-positive breast cancer. We assessed the tolerability, with particular focus on cardiac safety, of H and P with chemotherapy in the neoadjuvant treatment of HER2-positive early breast cancer.
In this multicenter, open-label phase II study, patients with operable, locally advanced, or inflammatory breast cancer were randomized 1 : 1 : 1 to receive six neoadjuvant cycles q3w (Arm A: 5-fluorouracil, epirubicin, cyclophosphamide [FEC] + H + P ×3 → docetaxel [T] + H + P ×3; Arm B: FEC ×3 → T + H + P ×3; Arm C: T + carboplatin + H [TCH]+P ×6). pCR was assessed at surgery and adjuvant therapy given to complete 1 year of H.
Two hundred twenty-five patients were randomized. During neoadjuvant treatment, two patients (2.7%; Arm B) experienced symptomatic left ventricular systolic dysfunction (LVSD) and 11 patients (Arm A: 4 [5.6%]; Arm B: 4 [5.3%]; Arm C: 3 [3.9%]) had declines in left ventricular ejection fraction of ≥10% points from baseline to <50%. Diarrhea was the most common adverse event. pCR (ypT0/is) was reported for 61.6% (Arm A), 57.3% (Arm B), and 66.2% (Arm C) of patients.
The combination of P with H and standard chemotherapy resulted in low rates of symptomatic LVSD.</description><subject>Anthracyclines - adverse effects</subject><subject>Anthracyclines - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Carboplatin - therapeutic use</subject><subject>Cyclophosphamide - therapeutic use</subject><subject>Docetaxel</subject><subject>early breast cancer</subject><subject>Epirubicin - therapeutic use</subject><subject>Female</subject><subject>Fluorouracil - therapeutic use</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Heart - drug effects</subject><subject>HER2</subject><subject>Humans</subject><subject>Inflammatory Breast Neoplasms - drug therapy</subject><subject>Inflammatory Breast Neoplasms - surgery</subject><subject>LVSD</subject><subject>Mammary gland diseases</subject><subject>Medical sciences</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>neoadjuvant</subject><subject>Neoadjuvant Therapy - methods</subject><subject>pertuzumab</subject><subject>Pharmacology. Drug treatments</subject><subject>Receptor, ErbB-2 - antagonists & inhibitors</subject><subject>Receptor, ErbB-2 - metabolism</subject><subject>Stroke Volume - drug effects</subject><subject>Taxoids - therapeutic use</subject><subject>Trastuzumab</subject><subject>Tumors</subject><subject>Ventricular Function, Left - drug effects</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc9rFDEUxwdR7Fo9epVchHoYm8xkfsTbUlZ3oWgp9eBpeJO86abMJGOS2TL9v72bMlsFQUII5H143y_fb5K8ZfQjoyI_B2OskeeDCqzOniUrVpQirSlnz5MVFVmeVkXOT5JX3t9RSkuRiZfJSZZXkRDlKvl1hS5MD9MALRn7yZPgwD99aEOkHVptIGhryL0Oe-IDGAVOEYMW1N10ABNIvHsHcpa9NphKawJoo81tHKh_hp1DJHKPgw17dDDOxOGtHtD4R7kxKqEJftHabq6zdLReB31AguD6mbQOo0EiwUh0nwgQFzXsoB9QkXEPHsluF6dOaZDEQ4dhjp4nNZOzm-sfV9v15uv6w-vkRQe9xzfH9zT5_nlzc7FNL7992V2sL1PJGQ0pCEYLziuUbZG3TJZUtB3yOh6aSyVbmcUcO8E41lDxOss4tFQUghe8LmL4p8nZsnd09ueEPjSD9hL7HmJ6k28Yz0TGKlZXEU0XVDrrvcOuGZ0ewM0No81j083SdLM0Hfl3x9VTO6D6Qz9VG4H3RwC8hL6LOUnt_3JVKapoP3LVwmEM4qDRNV7GDiQq7VCGRln9Hwu_AcC_zVQ</recordid><startdate>20130901</startdate><enddate>20130901</enddate><creator>Schneeweiss, A.</creator><creator>Chia, S.</creator><creator>Hickish, T.</creator><creator>Harvey, V.</creator><creator>Eniu, A.</creator><creator>Hegg, R.</creator><creator>Tausch, C.</creator><creator>Seo, J.H.</creator><creator>Tsai, Y.-F.</creator><creator>Ratnayake, J.</creator><creator>McNally, V.</creator><creator>Ross, G.</creator><creator>Cortés, J.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20130901</creationdate><title>Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA)</title><author>Schneeweiss, A. ; Chia, S. ; Hickish, T. ; Harvey, V. ; Eniu, A. ; Hegg, R. ; Tausch, C. ; Seo, J.H. ; Tsai, Y.-F. ; Ratnayake, J. ; McNally, V. ; Ross, G. ; Cortés, J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-a9105447ecb53b1c609bfe4848403cdcbc2704f914e8a748224ab095945485923</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Anthracyclines - adverse effects</topic><topic>Anthracyclines - therapeutic use</topic><topic>Antibodies, Monoclonal, Humanized - adverse effects</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Carboplatin - therapeutic use</topic><topic>Cyclophosphamide - therapeutic use</topic><topic>Docetaxel</topic><topic>early breast cancer</topic><topic>Epirubicin - therapeutic use</topic><topic>Female</topic><topic>Fluorouracil - therapeutic use</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Heart - drug effects</topic><topic>HER2</topic><topic>Humans</topic><topic>Inflammatory Breast Neoplasms - drug therapy</topic><topic>Inflammatory Breast Neoplasms - surgery</topic><topic>LVSD</topic><topic>Mammary gland diseases</topic><topic>Medical sciences</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>neoadjuvant</topic><topic>Neoadjuvant Therapy - methods</topic><topic>pertuzumab</topic><topic>Pharmacology. Drug treatments</topic><topic>Receptor, ErbB-2 - antagonists & inhibitors</topic><topic>Receptor, ErbB-2 - metabolism</topic><topic>Stroke Volume - drug effects</topic><topic>Taxoids - therapeutic use</topic><topic>Trastuzumab</topic><topic>Tumors</topic><topic>Ventricular Function, Left - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schneeweiss, A.</creatorcontrib><creatorcontrib>Chia, S.</creatorcontrib><creatorcontrib>Hickish, T.</creatorcontrib><creatorcontrib>Harvey, V.</creatorcontrib><creatorcontrib>Eniu, A.</creatorcontrib><creatorcontrib>Hegg, R.</creatorcontrib><creatorcontrib>Tausch, C.</creatorcontrib><creatorcontrib>Seo, J.H.</creatorcontrib><creatorcontrib>Tsai, Y.-F.</creatorcontrib><creatorcontrib>Ratnayake, J.</creatorcontrib><creatorcontrib>McNally, V.</creatorcontrib><creatorcontrib>Ross, G.</creatorcontrib><creatorcontrib>Cortés, J.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schneeweiss, A.</au><au>Chia, S.</au><au>Hickish, T.</au><au>Harvey, V.</au><au>Eniu, A.</au><au>Hegg, R.</au><au>Tausch, C.</au><au>Seo, J.H.</au><au>Tsai, Y.-F.</au><au>Ratnayake, J.</au><au>McNally, V.</au><au>Ross, G.</au><au>Cortés, J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA)</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2013-09-01</date><risdate>2013</risdate><volume>24</volume><issue>9</issue><spage>2278</spage><epage>2284</epage><pages>2278-2284</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Pertuzumab (P) combined with trastuzumab (H)-based chemotherapy improves efficacy in early and advanced HER2-positive breast cancer. We assessed the tolerability, with particular focus on cardiac safety, of H and P with chemotherapy in the neoadjuvant treatment of HER2-positive early breast cancer.
In this multicenter, open-label phase II study, patients with operable, locally advanced, or inflammatory breast cancer were randomized 1 : 1 : 1 to receive six neoadjuvant cycles q3w (Arm A: 5-fluorouracil, epirubicin, cyclophosphamide [FEC] + H + P ×3 → docetaxel [T] + H + P ×3; Arm B: FEC ×3 → T + H + P ×3; Arm C: T + carboplatin + H [TCH]+P ×6). pCR was assessed at surgery and adjuvant therapy given to complete 1 year of H.
Two hundred twenty-five patients were randomized. During neoadjuvant treatment, two patients (2.7%; Arm B) experienced symptomatic left ventricular systolic dysfunction (LVSD) and 11 patients (Arm A: 4 [5.6%]; Arm B: 4 [5.3%]; Arm C: 3 [3.9%]) had declines in left ventricular ejection fraction of ≥10% points from baseline to <50%. Diarrhea was the most common adverse event. pCR (ypT0/is) was reported for 61.6% (Arm A), 57.3% (Arm B), and 66.2% (Arm C) of patients.
The combination of P with H and standard chemotherapy resulted in low rates of symptomatic LVSD.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>23704196</pmid><doi>10.1093/annonc/mdt182</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Annals of oncology, 2013-09, Vol.24 (9), p.2278-2284 |
| issn | 0923-7534 1569-8041 |
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| subjects | Anthracyclines - adverse effects Anthracyclines - therapeutic use Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic agents Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Carboplatin - therapeutic use Cyclophosphamide - therapeutic use Docetaxel early breast cancer Epirubicin - therapeutic use Female Fluorouracil - therapeutic use Gynecology. Andrology. Obstetrics Heart - drug effects HER2 Humans Inflammatory Breast Neoplasms - drug therapy Inflammatory Breast Neoplasms - surgery LVSD Mammary gland diseases Medical sciences Multiple tumors. Solid tumors. Tumors in childhood (general aspects) neoadjuvant Neoadjuvant Therapy - methods pertuzumab Pharmacology. Drug treatments Receptor, ErbB-2 - antagonists & inhibitors Receptor, ErbB-2 - metabolism Stroke Volume - drug effects Taxoids - therapeutic use Trastuzumab Tumors Ventricular Function, Left - drug effects |
| title | Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA) |
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