Trial reportCancer chemotherapy and pharmacology2025
NSABP FC-11: A phase II study of neratinib plus trastuzumab or neratinib plus cetuximab in patients with "quadruple wild-type" (KRAS/NRAS/BRAF/PIK3CA) metastatic colorectal cancer based on HER2 status: amplified, non-amplified (wild-type), or mutated.
Trial report in Cancer chemotherapy and pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03457896 (A Phase II Study Evaluating the Combination of Neratinib Plus Trastuzumab or Neratinib Plus Cetuximab in Patients With "Quadruple Wild-Type"), which is not on this map. Cited by 1 paper.
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 II Study Evaluating the Combination of Neratinib Plus Trastuzumab or Neratinib Plus Cetuximab in Patients With "Quadruple Wild-Type" (KRAS/NRAS/BRAF/PIK3CA Wild-Type) Metastatic Colorectal Cancer Based on HER2 Status: Amplified, Non-Amplified (Wild-Type) or Mutated
Who cites it
1 citing paper in PubMed.
- Refractory Metastatic Colorectal Cancer: Current Challenges and Future Prospects.Cancer management and research · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients with KRAS wild-type (wt) metastatic colorectal cancer (mCRC) treated with single-agent cetuximab (C) or panitumumab (P), have improved progression-free survival (PFS) and overall survival (OS) compared to best supportive care but an objective response rate (ORR) of only 13-17%. Preclinical and clinical data suggest that dual targeted therapy (e.g., neratinib [N] + C) may improve overall response rates in tumors that are wt for KRAS, NRAS, BRAF, and PIK3CA (quadruple-wt).
methodsNSABP FC-11 is a multi-center, two-arm, phase II study in patients with quadruple-wt mCRC who had prior oxaliplatin and irinotecan treatment. Arm 1 treated patients with HER2 mutation, with or without prior C or P. Arm 2 treated HER2 non-amplified (14 evaluable) and HER2-amplified (1 evaluable) patients with N + C. The primary aim was PFS at cycle 6 (PFS6). Secondary aims included ORR, objective response, clinical benefit, and safety. Exploratory aims included molecular profiling for mutations, copy number, and RNA expression.
resultsArm 1 closed early due to low accrual (n = 4) and is not reported. Arm 2 enrolled 21 patients; six discontinued treatment before first scan. Fifteen patients were evaluable with at least one follow-up scan with six demonstrating PFS6. With intention-to-treat (ITT) analysis, this cohort demonstrated an ORR/PFS6 of 28% (6/21). No grade 5 or otherwise unexpected adverse events were noted. Correlative molecular studies did not definitively define responders.
conclusionArm 2 of FC-11 demonstrated an ORR/PFS6 of 28%, which compares favorably to single-agent treatment in this subset of patients. CLINICAL TRIALS REGISTRATION: NCT03457896.
Indexed as
Identifiers
40782152What 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.