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NCT04443348 · ClinicalTrials.gov registry record · Phase 2

Pre-op Pembro + Radiation Therapy in Breast Cancer (P-RAD)

A Phase 2 study of Triple Negative Breast Cancer and Hormone Receptor Positive (HR+), HER2-negative Breast Cancer, sponsored by Laura M. Spring, MD.

Active
Registry status
Phase 2
Development phase
120
Enrollment target
10
Study locations

NCT04443348: Active Phase 2 study of Triple Negative Breast Cancer and Hormone Receptor Positive (HR+), HER2-negative Breast Cancer, sponsored by Laura M. Spring, MD.

NCT04443348 is a Phase 2 study of Triple Negative Breast Cancer and Hormone Receptor Positive (HR+), HER2-negative Breast Cancer that is active but no longer recruiting, run by Laura M. Spring, MD. The registered enrollment target is 120 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (51% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04443348, a Phase 2 study of Triple Negative Breast Cancer and Hormone Receptor Positive (HR+), HER2-negative Breast Cancer, is active but no longer recruiting, sponsored by Laura M. Spring, MD.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
120 participants
Enrollment target
10
Study locations

Study Summary

This research trial is studying a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer. The names of the study interventions involved in this study are: * Radiation Therapy (RT) * Immunotherapy: Pembrolizumab (MK-3475) * Chemotherapies: * Paclitaxel * Doxorubicin (also called Adriamycin) * Cyclophosphamide * Carboplatin (optional, and in TN only) * Capecitabine (optional, and in TN only)

Primary Outcome

Quantitative immunofluorescence in post-treatment tumor biopsy samples collected on day 14-21 of C1 of Pembrolizumab.

Conditions Studied

Triple Negative Breast Cancer Hormone Receptor Positive (HR+), HER2-negative Breast Cancer Biopsy-proven, Positive Lymph Node(s)

Interventions

  • DRUG Pembrolizumab
  • DRUG Cyclophosphamide
  • DRUG Carboplatin
  • DRUG Paclitaxel
  • RADIATION Radiation Therapy Boost

Study Locations (10)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute - Boston

New York

  • Memorial Sloan Kettering Cancer Center - New York
  • Montefiore Medical Center - The Bronx

North Carolina

  • University of North Carolina Medical Center - Chapel Hill
  • Duke University Medical Center - Durham

District of Columbia

  • Sibley Memorial Hospital - Washington D.C.

Maryland

  • Johns Hopkins - Baltimore

Minnesota

  • Mayo Clinic - Rochester - Rochester

Texas

  • MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2020-12-16
Est. Completion 2027-08
Phase Phase 2
Laura M. Spring, MD

1 total trials

What the registry record for NCT04443348 still lists

NCT04443348 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (51% lower).

The record links to 3 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT04443348 lists 10 locations in 7 states (Massachusetts, New York, North Carolina).

Frequently Asked Questions

What is clinical trial NCT04443348 about?

NCT04443348 is a clinical study titled "Pre-op Pembro + Radiation Therapy in Breast Cancer (P-RAD)". This research trial is studying a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer. The names of the study interventions involved in this study are: * ...

What is the current status of trial NCT04443348?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2020-12-16. Estimated completion is 2027-08.

What conditions does trial NCT04443348 study?

This clinical trial studies the following conditions: Triple Negative Breast Cancer, Hormone Receptor Positive (HR+), HER2-negative Breast Cancer, Biopsy-proven, Positive Lymph Node(s).

What interventions are being tested in trial NCT04443348?

The interventions under investigation include: Pembrolizumab (DRUG), Cyclophosphamide (DRUG), Carboplatin (DRUG), Paclitaxel (DRUG), Radiation Therapy Boost (RADIATION).

Who is sponsoring clinical trial NCT04443348?

This trial is sponsored by Laura M. Spring, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04443348 being conducted?

This trial has 10 study locations across District of Columbia, Maryland, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Triple Negative Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04443348's enrollment target sits among peer trials

120 46th of 118 higher than 72 of 118 other Triple Negative Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Triple Negative Breast Cancer 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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Related registry views

Source: ClinicalTrials.gov NCT04443348, the US trial registry maintained by the National Library of Medicine. NCT04443348 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.