Klinische Studie

A phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant in combination with Phesgo versus Phesgo after induction therapy with Phesgo + taxane in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer (heredERA).(heredERA)Bewertung d. Wirksamkeit u. Sicherheit v. Giredestrant in Kombi. mit Phesgo vs. Phesgo nach Induktionstherapie mit Phesgo+Taxane bei Pat mit zuvor unbehandeltem HER2+, ER+ lokal fortges. oder met. BC
EUDRACT-
NCTNCT05296798
DRKS-
Krankheitsentität(en) Brust
StudientypInterventionsstudie
Wesentliche Einschlusskriterien• Signed Informed Consent Form • Participants (females, regardless of menopausal status, and males) who are aged ≥18 years at the time of signing Informed Consent Form – For women: postmenopausal or premenopausal status, defined as follows: A participant is considered postmenopausal if any of the following definitions are met: Prior bilateral oophorectomy Age ≥ 60 years Age ≤ 60 years and amenorrheic for 12 months or more in the absence of chemotherapy or ovarian suppression, and FSH and estradiol in the postmenopausal ranges – Pre- or perimenopausal (i.e., not meeting the criteria for postmenopausal) • Ability to comply with the study protocol, in the investigator’s judgment • Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection. – HER2-positive ABC confirmed by a central laboratory prior to study enrollment. HER2-positive status will be determined based on primary or metastatic lesion and defined as 3 + by immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of ≥ 2 for the number of HER2 gene copies to the number of signals for chromosome 17 copies. Participants will be eligible provided that at least one HER2 test (IHC or ISH) yields a positive result A representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 20 slides containing unstained, freshly cut, serial sections that meet the criteria outlined in Section 8.7 must be submitted prior to study enrollment. In exceptional circumstances, 11−19 slides are acceptable provided that other eligibility requirements are met; however, a minimum of 20 slides is highly preferred. For China, the number of slides required for eligibility will be based on Human Genetics Resources Administration of China (HGRAC) specifications. – Documented ER-positive tumor according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, assessed locally and defined as ≥1% of tumor cells staining positive for ER, preferentially based on the same lesion that was used to determine HER2 positivity. • At least one measurable lesion and/or non-measurable disease evaluable according to RECIST version 1.1 ...Biomarker_HER2+
Wesentliche Ausschlusskriterien- Previous systemic non-hormonal anti-cancer therapy in the MBC or ABC setting Note: Up to one line of single-agent ET given in the metastatic or locally-advanced setting will be allowed. One or two cycles of Phesgo (or trastuzumab SC with pertuzumab IV, or PH IV) with docetaxel or paclitaxel in the first line ABC setting is allowed prior to enrollment, provided no limiting toxicities or PD have occurred. - Prior treatment with a SERD (e.g., fulvestrant) - Previous treatment with approved or investigative anti-HER2 agents except Phesgo (or trastuzumab SC with pertuzumab IV, or PH IV), single-agent trastuzumab IV or SC, ado-trastuzumab emtansine, lapatinib, and neratinib in the neoadjuvant or adjuvant setting - Disease progression within 6 months of receiving adjuvant anti-HER2 therapy (such as trastuzumab, with or without pertuzumab [IV, SC, or fixed-dose combination], or ado-trastuzumab emtansine or neratinib) - Non-resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade 2 peripheral neuropathy, or other toxicities that are not considered a safety risk for the participant per investigator's judgment) - History of persistent Grade  2 (NCI-CTC, Version 5.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapy
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgFrauenheilkunde und Geburtshilfe Krankenhaus St JosefStudienzentrale0941 7823403fhk-studienzentrum(at)csj.de
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