Trial reportBMC medicine2022
Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial.
Trial report in BMC medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 64 papers, 2 of them syntheses 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 Randomized, Muticenter Double-blind Phase III Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Docetaxel Compared With Placebo Plus Trastuzumab and Docetaxel in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
Prospective, Single-arm, Single-center Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of Elderly Advanced Triple-positive Breast Cancer.
Who cites it
64 citing papers in PubMed, 2 syntheses or guidelines pooled it, 75 citations in OpenAlex.
- Efficacy and safety of small-molecule TKIs in neoadjuvant treatment of HER2-positive breast cancer: a systematic review and network meta-analysis.BMC cancer · 2025Pooled it
- Efficacy and safety of first-line therapy in patients with HER2-positive advanced breast cancer: a network meta-analysis of randomized controlled trials.Journal of cancer research and clinical oncology · 2024Pooled it
- Efficacy and safety of neoadjuvant treatment of trastuzumab and pyrotinib plus dalpiciclib in HR-negative/HER2-positive breast cancer: an exploratory, open-label phase II study.International journal of surgery (London, England) · 2026Trial
- Pathological response and metabolites' prognostic role in HER2-positive breast cancer treated with neoadjuvant pyrotinib, trastuzumab, nab-paclitaxel, and carboplatin: a single-arm phase II trial.Breast cancer research : BCR · 2025Trial
- Neoadjuvant ARX788 plus pyrotinib versus trastuzumab, pertuzumab, docetaxel and carboplatin for HER2-positive breast cancer: a randomised phase 2b trial.Nature communications · 2025Trial
- Trial
- Combination Therapy of Pyrotinib and Metronomic Vinorelbine in HER2+ Advanced Breast Cancer after Trastuzumab Failure (PROVE): A Prospective Phase 2 Study.Cancer research and treatment · 2025Trial
- Preclinical study and phase 2 trial of neoadjuvant pyrotinib combined with chemotherapy in luminal/HER2-low breast cancer: PILHLE-001 study.Cell reports. Medicine · 2024Trial
- De-Escalation of Neoadjuvant Treatment for HER2-Positive Breast Cancer.International journal of cancer · 2026Review
- Article
- Article
- Spatially interpretable artificial intelligence framework to tailored neoadjuvant dual HER2 blockade in HER2-positive breast cancer.Signal transduction and targeted therapy · 2026Article
- Association between diarrhea and survival in patients with HER2-positive advanced breast cancer treated with pyrotinib-based therapy: A landmark analysis from the real-world PRETTY study.Breast (Edinburgh, Scotland) · 2026Article
- Targeted Therapies for Each Subtype of Breast Cancer.MedComm · 2026Review
- SHR-A1811, a novel HER2-targeting antibody-drug conjugate, in advanced solid tumors (HORIZON-X): a global phase 1 trial.Signal transduction and targeted therapy · 2026Article
- Advances in the study of pyrotinib for the treatment of HER2-positive breast cancer.Breast cancer research : BCR · 2026Review
- Next Frontier in HER2+/HR+ Breast Cancer: Leveraging Cell Cycle Control with CDK4/6 Inhibitors.Journal of personalized medicine · 2026Review
- Article
- (Neo)adjuvant therapy patterns and outcomes in patients with HR+/HER2+ early breast cancer: a real-world study using the national cancer information database in China.Therapeutic advances in medical oncology · 2026Article
- Article
4 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 17 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPyrotinib (an irreversible pan-ErbB inhibitor) plus capecitabine has survival benefits and acceptable tolerability in patients with HER2-positive metastatic breast cancer. We further assessed addition of pyrotinib to trastuzumab and docetaxel in the neoadjuvant setting.
methodsIn this multicenter, double-blind, phase 3 study (PHEDRA), treatment-naive women with HER2-positive early or locally advanced breast cancer were randomly assigned (1:1) to receive four neoadjuvant cycles of oral pyrotinib or placebo (400 mg) once daily, plus intravenous trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg) and docetaxel (100 mg/m
resultsBetween Jul 23, 2018, and Jan 8, 2021, 355 patients were randomly assigned, 178 to the pyrotinib group and 177 to the placebo group. The majority of patients completed four cycles of neoadjuvant treatment as planned (92.7% and 97.7% in the pyrotinib and placebo groups, respectively). The tpCR rate was 41.0% (95% CI 34.0 to 48.4) in the pyrotinib group compared with 22.0% (95% CI 16.6 to 28.7) in the placebo group (difference, 19.0% [95% CI 9.5 to 28.4]; one-sided P < 0.0001). The objective response rate per investigator was 91.6% (95% CI 86.6 to 94.8) in the pyrotinib group and 81.9% (95% CI 75.6 to 86.9) in the placebo group after the neoadjuvant treatment, resulting in an increase of 9.7% (95% CI 2.7 to 16.6). The most common grade 3 or worse adverse events were diarrhea (79 [44.4%] in the pyrotinib group and nine [5.1%] in the placebo group), neutropenia (33 [18.5%] and 36 [20.3%]), and decreased white blood cell count (29 [16.3%] and 24 [13.6%]). No deaths were reported during neoadjuvant treatment.
conclusionsThe primary endpoint of the study was met. Neoadjuvant pyrotinib, trastuzumab, and docetaxel significantly improved the tpCR rate compared with placebo, trastuzumab, and docetaxel, with manageable toxicity, providing a new option for HER2-positive early or locally advanced breast cancer.
trial registrationClinicalTrials.gov, NCT03588091.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.