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Comparison · NCT03742986-15efd7bf

HER2-negative, Including TNBC or HR-positive vs HER2-positive, Independent of HR Status: Number of Participants Who Had a Pathological Complete Response (pCR)

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. HER2-negative, Including TNBC or HR-positive vs HER2-positive, Independent of HR Status: Number of Participants Who Had a Pathological Complete Response (pCR). Trial comparisons, record NCT03742986-15efd7bf. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03742986-15efd7bf

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.49wilson
Risk in group 20.750.3010.954wilson
Risk difference, group 1 minus group 2-0.75-0.954-0.0852newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer participant with the outcome on HER2-negative, Including TNBC or HR-positive than on HER2-positive, Independent of HR Status1.331.0511.7from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1HER2-negative, Including TNBC or HR-positive
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)~Paclitaxel 80mg/m\^2: Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)~Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)~Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
04OG000
Group 2HER2-positive, Independent of HR Status
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)~Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)~Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)~Paclitaxel 80mg/m\^2 or Docetaxel 75mg/m\^2: Paclitaxel 80mg/m\^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m\^2 on Day 1 of every 21 day cycle (Cycle 1-4)~Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4~Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
34OG001

Outcome

Type
PRIMARY
Title
Number of Participants Who Had a Pathological Complete Response (pCR)
Description
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Time frame
up to 16 weeks
Population

Source ClinicalTrials.gov

Trial

Title
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
NCT number
NCT03742986
Phases
PHASE2
Conditions
Breast Cancer
Interventions
Nivolumab 360mg, Paclitaxel 80mg/m^2, Doxorubicin 60mg/m^2, Cyclophosphamide 600mg/m^2, Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2, Trastuzumab 8mg/kg and 6 mg/kg, Pertuzumab 840mg and 420mg
Lead sponsor
NYU Langone Health
Results first posted
2022-02-25

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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