Trial reportBreast cancer research and treatment2015
SOLTI NeoPARP: a phase II randomized study of two schedules of iniparib plus paclitaxel versus paclitaxel alone as neoadjuvant therapy in patients with triple-negative breast cancer.
Trial report in Breast cancer research and treatment, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 4 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- PARP inhibitor plus chemotherapy versus chemotherapy alone in patients with triple-negative breast cancer: a systematic review and meta-analysis based on randomized controlled trials.Cancer chemotherapy and pharmacology · 2023Pooled it
- Incidence of myelodysplastic syndrome and acute myeloid leukemia in patients receiving poly-ADP ribose polymerase inhibitors for the treatment of solid tumors: A meta-analysis of randomized trials.Gynecologic oncology · 2021Pooled it
- Pooled it
- Efficacy and Safety of Poly (ADP-Ribose) Polymerase Inhibitors in Combination with Chemotherapy for Advanced Breast Cancer: A Systematic Review and Meta-Analysis.Technology in cancer research & treatmentPooled it
- Overcoming Resistance in Triple-Negative Breast Cancer: A Translational Perspective on Next-Generation DNA Damage Response Inhibitors and Synthetic Lethality.Molecules (Basel, Switzerland) · 2026Review
- Homologous recombination pathway alterations in basal-like breast cancer.Frontiers in oncology · 2026Review
- Molecular pathways and therapeutic targets linked to triple-negative breast cancer (TNBC).Molecular and cellular biochemistry · 2024Review
- Small molecule agents for triple negative breast cancer: Current status and future prospects.Translational oncology · 2024Review
- Current Advancements of Plant-Derived Agents for Triple-Negative Breast Cancer Therapy through Deregulating Cancer Cell Functions and Reprogramming Tumor Microenvironment.International journal of molecular sciences · 2021Review
- Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trial.NPJ breast cancer · 2021Article
- Investigational Drug Treatments for Triple-Negative Breast Cancer.Journal of personalized medicine · 2021Review
- Optimal Management for Residual Disease Following Neoadjuvant Systemic Therapy.Current treatment options in oncology · 2021Review
- Breast cancer liver metastasis: current and future treatment approaches.Clinical & experimental metastasis · 2021Review
- Review
- A Bayesian network meta-analysis of the efficacy of targeted therapies and chemotherapy for treatment of triple-negative breast cancer.Cancer medicine · 2019Article
- Progress in targeted therapy for breast cancer.Chronic diseases and translational medicine · 2018Article
- Cisplatin versus carboplatin in combination with paclitaxel as neoadjuvant regimen for triple negative breast cancer.OncoTargets and therapy · 2017Article
- Glycophenotype of breast and prostate cancer stem cells treated with thieno[2,3-Drug design, development and therapy · 2017Article
- Appraising iniparib, the PARP inhibitor that never was--what must we learn?Nature reviews. Clinical oncology · 2013Review
- Neoadjuvant therapy in operable breast cancer: application to triple negative breast cancer.Journal of oncology · 2013Article
Corrections and comments
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Authors and funding
21 authors.
Funding
Abstract
Iniparib is an investigational agent with antitumor activity of controversial mechanism of action. Two previous trials in advanced triple-negative breast cancer (TNBC) in combination with gemcitabine and carboplatin showed some evidence of efficacy that was not confirmed. This phase II randomized neoadjuvant study was designed to explore its activity and tolerability with weekly paclitaxel (PTX) as neoadjuvant treatment in TNBC patients. 141 patients with Stage II-IIIA TNBC were randomly assigned to receive PTX (80 mg/m(2), d1; n = 47) alone or in combination with iniparib, either once-weekly (PWI) (11.2 mg/kg, d1; n = 46) or twice-weekly (PTI) (5.6 mg/kg, d1, 4; n = 48) for 12 weeks. Primary endpoint was pathologic complete response (pCR) in the breast. pCR rate was similar among the three arms (21, 22, and 19 % for PTX, PWI, and PTI, respectively). Secondary efficacy endpoints were comparable: pCR in breast and axilla (21, 17, and 19 %); best overall response in the breast (60, 61, and 63 %); and breast conservation rate (53, 54, and 50 %). Slightly more patients in the PTI arm presented grade 3/4 neutropenia (4, 0, and 10 %). Grade 1/2 (28, 22, and 29 %), but no grade 3/4 neuropathy, was observed. There were no differences in serious adverse events and treatment-emergent adverse events leading to treatment discontinuation among the three arms. Addition of iniparib to weekly PTX did not add relevant antitumor activity or toxicity. These results do not support further evaluation of the combination of iniparib at these doses plus paclitaxel in early TNBC.
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Registered trials
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