Abstract P5-19-11: Noninterventional study HELENA – Advanced (metastatic or locally recurrent, inoperable) HER2-positive breast cancer: First-Line trEatmeNt with pertuzumAb after adjuvant trastuzumab therapy

Background: The CLEOPATRA trial (808 patients) demonstrated a significant benefit for overall survival (HR=0.66; 95% CI 0.52−0.84; p Methods & Aims: HELENA is a multicentre, noninterventional study recruiting patients with advanced HER2-positive breast cancer, who relapsed after receiving trastuzumabin the adjuvant setting. All patients receive first line treatment with pertuzumabin combination with trastuzumaband docetaxel in clinical routine in Germany according to local SmPC. The main objective of HELENA is to confirm the progression free survival of 16.9 months observed in the CLEOPATRA trial in this specific patient population in a real world setting. Parameters of interest: · Time-based efficacy parameters of pertuzumabin combination with trastuzumaband docetaxel, in particular PFS in female patients with prior trastuzumabtreatment in the adjuvant setting and in clinically relevant subgroups (hormone receptor-positive and -negative, visceral and non-visceral metastatic disease, patients · Interval between the last documented dose of the adjuvant trastuzumabtreatment and the onset of pertuzuab first-line treatment · Effective treatment duration, reason for treatment discontinuations and treatment modifications · Demographic characteristics and medical history of the patient · Evaluation of potential prognostic variables: ECOG performance status, co-morbidity, tumor stage, type of histological classification, histologic grading, location of metastases, primary surgery method, residual tumor burden · Extension and localization of metastasis or locally recurrent, inoperable tumor before onset of pertuzuab first-line treatment · Safety of pertuzumab: Incidence, management and outcome of (S)AEs and pregnancies · Outcome of (neo)adjuvant (DFS) trastuzumabtherapy Recruitment: HELENA started recruitment in June 2013 and will enroll 478 patients in 150 sites, being suitable in number, type and geographic distribution for providing a representative picture of first-line treatment of advanced (metastatic or locally recurrent, inoperable) HER2-positive breast cancer in Germany. Results: First interim results of HELENA will be presented at the SABCS 2014 meeting. Citation Format: Marc Thill, Katja Ziegler-Lohr, Harald Wagner, Gertrud Helling-Giese, Jasmin Greinemann, Otto Schmalhofer, Dietmar Reichert. Noninterventional study HELENA – Advanced (metastatic or locally recurrent, inoperable) HER2-positive breast cancer: First-Line trEatmeNt with pertuzumAbafter adjuvant trastuzumabtherapy [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-19-11.