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NCT01275677 · ClinicalTrials.gov registry record · Phase 3

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

A Phase 3 study of Recurrent Breast Carcinoma and Stage IIA Breast Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
3,270
Enrollment target
20
Study locations

NCT01275677 is a Phase 3 study of Recurrent Breast Carcinoma and Stage IIA Breast Cancer AJCC v6 and v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 3,270 participants, above the 178-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (1737% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT01275677, a Phase 3 study of Recurrent Breast Carcinoma and Stage IIA Breast Cancer AJCC v6 and v7, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
3,270 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Docetaxel
  • DRUG Doxorubicin
  • OTHER Laboratory Biomarker Analysis
  • DRUG Doxorubicin Hydrochloride

Study Locations (20)

Alaska

  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage
  • Fairbanks Memorial Hospital - Fairbanks

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Kaiser Permanente-Deer Valley Medical Center - Antioch
  • PCR Oncology - Arroyo Grande
  • Sutter Auburn Faith Hospital - Auburn
  • Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
  • Kaiser Permanente-Baldwin Park - Baldwin Park

Alabama

  • Northeast Alabama Regional Medical Center - Anniston
  • Providence Hospital - Mobile
  • University of South Alabama Mitchell Cancer Institute - Mobile

Arkansas

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
  • NEA Baptist Memorial Hospital - Jonesboro
  • University of Arkansas for Medical Sciences - Little Rock

Arizona

  • Arizona Oncology Associates-Biltmore Cancer Center - Phoenix
  • Virginia G Piper Cancer Care-Del Camino - Scottsdale

Trial Details

FieldValue
Enrollment Target 3,270 participants
Start Date 2011-02-08
Est. Completion 2025-06-02
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01275677

The ClinicalTrials.gov registry entry for NCT01275677 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,270 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 178-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (1737% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Recurrent Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT01275677 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT01275677 about?

NCT01275677 is a clinical study titled "Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer". This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stoppi...

What is the current status of trial NCT01275677?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,270 participants. The study started on 2011-02-08. Estimated completion is 2025-06-02.

What conditions does trial NCT01275677 study?

This clinical trial studies the following conditions: Recurrent Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIIC Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage IIB Breast Cancer AJCC v6 and v7.

What interventions are being tested in trial NCT01275677?

The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Doxorubicin (DRUG), Laboratory Biomarker Analysis (OTHER), Doxorubicin Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT01275677?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01275677 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.