Background: The CLEOPATRA trial (808 patients) demonstrated a significant benefit for overall survival (HR=0.66; 95% CI 0.52−0.84; p<0.0008) and progression free survival (HR=0.62; 95% CI 0.51−0.75; p<0.0001) in the first line treatment of patients with HER2-positive metastatic breast cancer (MBC) receiving pertuzumab in addition to trastuzumab plus docetaxel. An exploratory subgroup analysis was performed for patients who had received prior neoadjuvant and/or adjuvant trastuzumab therapy (88 patients). The observed hazard ratios of 0.68 (95% CI 0.30−1.55) and 0.62 (95% CI 0.35–1.07; 16.9 months) indicate a benefit in overall and progression free survival for this subpopulation.

Methods & Aims: HELENA is a multicentre, noninterventional study recruiting patients with advanced HER2-positive breast cancer, who relapsed after receiving trastuzumab in the adjuvant setting. All patients receive first line treatment with pertuzumab in combination with trastuzumab and 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 pertuzumab in combination with trastuzumab and docetaxel, in particular PFS in female patients with prior trastuzumab treatment in the adjuvant setting and in clinically relevant subgroups (hormone receptor-positive and -negative, visceral and non-visceral metastatic disease, patients < 65 years and ≥ 65 years as well as < 75 years and ≥ 75 years)

· Interval between the last documented dose of the adjuvant trastuzumab treatment 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) trastuzumab therapy

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-Löhr, 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 pertuzumAb after adjuvant trastuzumab therapy [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.