Trial reportJournal of cancer research and clinical oncology2023
Neoadjuvant endocrine therapy with or without palbociclib in low-risk patients: a phase III randomized double-blind SAFIA trial.
Trial report in Journal of cancer research and clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03447132 (Multicentre, International Neoadjuvant Randomized Double-blind Trial Comparing Fulvestrant® to a Combination of Fulvestrant® and Palbociclib), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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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.
Multicentre, International Neoadjuvant Randomized Double-blind Trial Comparing Fulvestrant® to a Combination of Fulvestrant® and Palbociclib (CDK 4/6 Inhibitor) in Patients With Operable Luminal Breast Cancer Responding to Fulvestrant®
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.
- Reporting on patient's body mass index (BMI) in recent clinical trials for patients with breast cancer: a systematic review.Breast cancer research : BCR · 2024Pooled it
- Adjuvant and neoadjuvant therapy with or without CDK4/6 inhibitors in HR+/HER2- early breast cancer: a systematic review and meta-analysis.Frontiers in pharmacology · 2024Pooled it
- Neoadjuvant palbociclib in women with operable, hormone receptor-positive breast cancer.Endocrine-related cancer · 2025Trial
- Clinical efficacy and therapy response prediction of neoadjuvant dalpiciclib plus letrozole in postmenopausal patients with HR+/HER2- stage II-III breast cancer (DARLING 01): a single-arm, open-label, exploratory study.Breast cancer research : BCR · 2025Trial
- Predictive value of serial dynamic lipid monitoring for pathologic complete response to neoadjuvant chemotherapy in luminal breast cancer: a retrospective study integrating metabolic and clinical indicators.BMC women's health · 2026Article
- Efficacy of neoadjuvant endocrine therapy with CDK4/6 inhibitors in locally advanced breast cancer.The oncologist · 2026Article
- Concordance of Oncotype DX Breast Recurrence Score Assay Results Between Paired Core Needle Biopsy and Surgical Excision Specimens in Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative, Early-Stage Breast Cancer.JCO precision oncology · 2025Article
- Gene Expression Signatures for Guiding Initial Therapy in ER+/HER2- Early Breast Cancer.Cancers · 2025Review
- Review
- Reporting on invasive lobular breast cancer in clinical trials: a systematic review.NPJ breast cancer · 2024Review
- The Magee 3 Equation Predicts Favorable Pathologic Response to Neoadjuvant Endocrine Therapy in Breast Cancer Patients.Cancers · 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
29 authors at 14 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe most prevalent subtype of breast cancer (BC) is luminal hormonal-positive breast cancer. The neoadjuvant chemotherapy regimens have side effects, emphasizing the need to identify new startegies.
objectiveAnalyze the complete pathologic response (pCR) rate and overall response in a low-risk hormone-positive subset of patients receiving neoadjuvant hormone treatment (NAHT) with or without Palbociclib (a CDK4/CDK6 inhibitor) to boost NAHT effectiveness. MATERIALS AND
methodsBased on the upfront 21-gene Oncotype DX or low-risk Breast Recurrence Score assay (RS™), the SAFIA trial is designed as a prospective multicenter international, double-blind neoadjuvant phase-III trial that selects operable with luminal BC patients that are HER2-negative for the induction hormonal therapy with Fulvestrant 500 mg ± Goserelin (F/G) followed by randomization of responding patients to palbociclib versus placebo. The pCR rate served as the study's main outcome, while the secondary endpoint was a clinical benefit.
resultsOf the 354 patients enrolled, 253 initially responded and were randomized to either F/G fulvestrant with palbociclib or placebo. Two hundred twenty-nine were eligible for the evaluation of the pathologic response. No statistically significant changes were observed in the pCR rates for the patients treated with the F/G therapy with placebo or palbociclib (7% versus 2%, respectively) per the Chevallier classification (Class1 + Class2) (p = 0.1464) and 3% versus 10% assessed per Sataloff Classification (TA, NA/NB) (p = 0.3108). Palbociclib did not increase the rate of complete pathological response.
conclusionNeoadjuvant hormonal therapy is feasible in a selected population with a low RS score of < 31 CLINICAL TRIAL: NCT03447132.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.