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NCT03301350 · ClinicalTrials.gov registry record · Phase 2

Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer

A Phase 2 study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Phase 2
Development phase
29
Enrollment target

NCT03301350: Completed Phase 2 study, sponsored by University of Wisconsin, Madison.

NCT03301350 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03301350, a Phase 2 study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 2
Development phase
29 participants
Enrollment target

Study Summary

This is a phase II single-arm, open-label, prospective study to evaluate the efficacy of the low dose weekly Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide in subjects with triple-negative breast cancer in neoadjuvant settings.

Primary Outcome

pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. pCR will be assessed according to RECIST 1.1 criteria. The point estimate of the primary efficacy endpoint pCR and its exact 95% confidence intervals (CI) will be calculated. In evaluating pCR, subjects with missing data will be considered non-responders.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Carboplatin
  • DRUG Doxorubicin
  • DRUG Paclitaxel
  • DRUG Pegfilgrastim

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2017-11-07
Est. Completion 2022-02-07
Phase Phase 2
University of Wisconsin, Madison

1,039 total trials

What the finished NCT03301350 record still lists

NCT03301350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT03301350 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03301350 about?

NCT03301350 is a clinical study titled "Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer". This is a phase II single-arm, open-label, prospective study to evaluate the efficacy of the low dose weekly Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide in subjects with triple-negative breast cancer in neoadjuvant settings.

What is the current status of trial NCT03301350?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2017-11-07. Estimated completion is 2022-02-07.

What interventions are being tested in trial NCT03301350?

The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Pegfilgrastim (DRUG).

Who is sponsoring clinical trial NCT03301350?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03301350's enrollment target sits among peer trials

29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03301350, the US trial registry maintained by the National Library of Medicine. NCT03301350 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.