Trial reportESMO open2025
PROMENADE: pembrolizumab for early ER-low/HER2-negative breast cancer, real-world French cohort.
Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03036488 (A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Association between endocrine therapy and survival outcomes in estrogen receptor-low breast cancer: a systematic review and meta-analysis.The oncologist · 2026Pooled it
- New perspectives on endocrine therapy suitability for hormone receptor-positive metastatic breast cancer in clinical practice.Breast (Edinburgh, Scotland) · 2026Review
- Characteristics and outcomes of patients with HER2-negative metastatic breast cancers with low expression of estrogen and progesterone receptors in the multicenter ESME cohort.Breast (Edinburgh, Scotland) · 2026Article
- Risk stratification and relapse pattern in triple-negative breast cancer with pathological complete response after neoadjuvant treatment: the European GAMBIT real-world study.Nature communications · 2026Observational
- Receptor discordance between primary tumors and nodal metastases and correlation with the 21-gene recurrence score in early-stage, estrogen receptor-positive, node-positive breast cancer.Breast cancer research and treatment · 2026Article
- Therapy as a State-Generator: Dynamic Phenotypic Landscapes and Adaptive Stress Circuits in Chemotherapy Resistance of Breast Cancer.Antioxidants (Basel, Switzerland) · 2026Review
- Estrogen Receptor-Low Positive (ER-Low) Breast Cancer: A Unique Clinical and Pathological Entity.Current oncology (Toronto, Ont.) · 2026Review
- Distribution and molecular drivers of the 21-gene recurrence score in early breast cancer with low, intermediate, and high estrogen receptor expression.Frontiers in immunology · 2026Article
- Prognosis and Biological Characteristics of ER-Low Metastatic Breast Cancer: Results from a Multicenter Cohort and the TONIC Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Article
- Transforming Breast Cancer Care: Cutting-Edge Insights and Future Directions.Journal of clinical medicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the phase III KEYNOTE-522 study (NCT03036488), which defined triple-negative breast cancers (TNBCs) as tumours with an estrogen receptor (ER) level ≤1% (ER-null) according to European Society for Medical Oncology (ESMO) and American Society of Clinical Oncology (ASCO) guidelines, the rate of pathological complete response (pCR) was increased by pembrolizumab addition to neoadjuvant chemotherapy. This combination has become the standard of care for stage II or III TNBC. However, updated ASCO guidelines suggest that tumours with low ER levels should be treated as ER-null. In some European countries, tumours with 1%-9% ER expression, called 'ER-low', are considered and treated as ER-null despite a lack of data concerning this population. PATIENTS AND
methodsWe conducted a retrospective real-world study in 16 comprehensive cancer centres across France. All patients with ER-low (ER 1%-9%), human epidermal growth factor receptor 2 (HER2)-negative BC receiving KEYNOTE-522 regimen since its availability in early 2022 were collected. The primary objective was to report the locally assessed pCR (ypT0/isN0 or residual cancer burden 0) rate in this population.
resultsWe included 155 female patients. The median age was 47.6 years (range 19.5-80.1 years), and 89 (57.4%) were premenopausal. One hundred thirty-seven (88.4%) patients had a tumour size ≥T2, and 83 (53.5%) were lymph node negative. Most tumours (n = 143; 93.6%) were invasive carcinoma of no special type and had aggressive characteristics, with 131 (85.6%) grade 3 and a median Ki67 of 70% (range 10%-100%). Eighty (51.6%) patients had HER2-low BC. Ninety-eight patients (63.2%) completed the KEYNOTE 522 regimen without deviation. Surgery consisted of a lumpectomy for 86 (56.2%) patients and a sentinel lymph node biopsy for 79 (52.7%) patients. One hundred and eleven (71.9%) patients had a pCR. In multivariable analysis, Nottingham Histologic Score grade 3 and stage III was significantly associated with pCR.
conclusionsER-low/HER2-negative tumours had a high rate of pCR after the KEYNOTE-522 regimen. Our results suggest that patients with ER-low HER2-negative BC should be treated as ER-null/HER2-negative BC in the neoadjuvant setting to maximise pCR.
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