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NCT01358877 · ClinicalTrials.gov registry record · Phase 3

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

A Phase 3 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
4,804
Enrollment target

NCT01358877 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 4,804 participants.

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The verdict

NCT01358877, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
4,804 participants
Enrollment target

Study Summary

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

Interventions

  • DRUG Cyclophosphamide
  • DRUG Carboplatin
  • DRUG Docetaxel
  • DRUG Doxorubicin
  • DRUG 5-Fluorouracil

Trial Details

FieldValue
Enrollment Target 4,804 participants
Start Date 2011-11-08
Est. Completion 2024-11-28
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01358877

The ClinicalTrials.gov registry entry for NCT01358877 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,804 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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

NCT01358877 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01358877 about?

NCT01358877 is a clinical study titled "A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer". This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with ...

What is the current status of trial NCT01358877?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,804 participants. The study started on 2011-11-08. Estimated completion is 2024-11-28.

What interventions are being tested in trial NCT01358877?

The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Docetaxel (DRUG), Doxorubicin (DRUG), 5-Fluorouracil (DRUG).

Who is sponsoring clinical trial NCT01358877?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

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

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.