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EMBRACA Study
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Support & ResourcesSupportVideosMaterialsTALZENNA efficacyPrimary endpoint & subgroup analysisSecondary endpoints: ORRSecondary endpoint: OSExploratory endpoints: DoR & TTRTALZENNA safetySafety and tolerabillityAdverse eventsHematologic/Nonhematologic AEsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptoms
Talzenna MoA

The content of this website has been produced in line with the Talzenna®▼ Summary of Product Characteristics for Great Britain and Northern Ireland. Talzenna® (talazoparib) Prescribing Information for Great Britain and Northern Ireland click here.  Adverse event reporting information can be found at the bottom of the page.

EMBRACA Study: Patient-Reported Outcomes (PROs)PROs were included as exploratory endpoints in this open-label study; analyses were prespecified and adjustments for multiplicity were not made. No efficacy conclusions can be made from these data.1Baseline EORTC QLQ-C30 and QLQ-BD23 scores in the PRO-evaluable population1aSignificant overall improvement from baseline in GHS/QOL* and delayed time to definitive clinically meaningful deterioration†‡ in GHS/QOL vs. chemotherapy§ll4 Significant overall improvement from baseline in GHS/QOL* and delayed time to definitive clinically meaningful deterioration†‡ in GHS/QOL vs. chemotherapy§ll4  Adapted from Ettl J, et al. Ann Oncol 2018.1PRO-evaluable population defined as all patients who have completed 1 PRO question at baseline and 1 PRO question post baseline.Physician’s choice of chemotherapy included capecitabine, eribulin, gemcitabine or vinorelbineLarger values better.Larger values worse.Global health/QoL scores (prespecified exploratory endpoint)Baseline mean scores for GHS/QoL were similar in the TALZENNA® and chemotherapy arms (61.9 [95% CI 59.0–64.7] vs 60.9 [95% CI 56.9, 64.9], respectively). Higher GHS/QoL scores indicate a better quality of life.1

Definitive clinically meaningful deterioration in GHS/QoL was defined as the time from randomization to the first observation with a ≥10–point decrease and no subsequent observations with a <10–point decrease from baseline.1,2Estimated overall mean change from baseline in global health/QoL scores with TALZENNA vs. chemotherapy*2 Adapted from Litton JK, et al. Ann Oncol. 2020.Data cutoff: 30 September 2019. Median follow-up of 44.9 months (95% CI 37.9–47.0) and 36.8 months (95% CI 34.3–43.0), in the TALZENNA® group and the chemotherapy group, respectively.Physician’s choice of chemotherapy included capecitabine, eribulin, gemcitabine or vinorelbine.Overall change from baseline in functional and symptoms scales (prespecified exploratory endpoint)†‡1Cancer-related and breast cancer specific symptoms and functions in patients recieving TALZENNA versus chemotherapy1*†

Definitive clinically meaningful deterioration in GHS/QoL was defined as the time from randomisation to the first observation with a ≥10–point decrease and no subsequent observations with a <10–point decrease from baseline.1,2

Example

Figure adapted from Ettl J, et al. 2018.1* Physician’s choice of chemotherapy included capecitabine, eribulin, gemcitabine or vinorelbine.
† Baseline scores for all five QLQ-C30 functional scales were similar between the two treatment arms, with high functional levels in both. Mean baseline scores for the symptom scales of EORTC QLQ-C30 were similar in both treatment arms for all symptoms. Baseline scores for the symptoms indicate low symptom severity in both treatment arms.
‡ The sample size for “sexual enjoyment” was smaller (TALZENNA=102; chemotherapy=41) than other functional scales because the patients were only asked to answer this question if they had answered in a previous question that they were sexually active.
§ The sample size for “Upset by hair loss” was smaller (TALZENNA=59; chemotherapy=27) than the other symptom scales because patients were only asked to answer this question if they had answered in a previous question that they were experiencing hair loss.Time to clinically meaningful deterioration in patient-reported breast symptoms (prespecified exploratory endpoint)Time to clinically meaningful deterioration in patient-reported breast symptoms with TALZENNA versus chemotherapy*¶2

Definitive clinically meaningful deterioration in GHS/QoL was defined as the time from randomisation to the first observation with a ≥10–point decrease and no subsequent observations with a <10–point decrease from baseline.1,2
Type of Adverse Reactions  Adverse Reactions Withhold TALZENNA Until Levels Resolve to  Resume TALZENNA
Hematologic Hemoglobin
<8 g/dL		 ≥9 g/dL Resume TALZENNA at a reduced dose
Platelet count <50,000/μL ≥75,000/μL
Neutrophil count <1,000/μL ≥1,500/μL
Nonhematologic Grade 3 or Grade 4 ≤ Grade 1 Consider resuming TALZENNA at a reduced dose or discontinue 
Adapted from Litton JK, et al. Ann Oncol. 2020.2
Data cutoff: 30 September 2019. Median follow-up of 44.9 months (95% CI: 37.9-47.0) and 36.8 months (95% CI: 34.3-43.0) in the TALZENNA group and the chemotherapy group, respectively. * Physician’s choice of chemotherapy included capecitabine, eribulin, gemcitabine or vinorelbine.
¶ Breast Symptoms Scale as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23).CI, confidence interval; EORTC, European Organisation for Research and Treatment of Cancer; GHS, global health status; HR, hazard ratio; ITT, intention-to-treat; PRO, patient-reported outcome; QLQ-BR23, quality of life breast cancer questionnaire; QLQ-C30, quality of life core questionnaire; QOL, quality of life; NR, not reached; mTTD, median time-to-deteriorationExplore more EMBRACA study - Efficacy Outcomes

View the Efficacy Outcomes page

Learn moreLoading EMBRACA study - Safety Profile and Tolerability

View the Safety Profile and Tolerability page

 Learn moreLoadingReferences:Ettl J, et al. Ann Oncol. 2018;29:1939-1947. Litton JK, et al. Ann Oncol. 2020;31(11):1526-1535.
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