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COMPLETED Phase 3

A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

NCT02131064 · View on ClinicalTrials.gov ↗

Study Summary

This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (\>/=) 2 centimeters (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by surgery, and an adjuvant treatment period. Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination.

Conditions Studied

Interventions

  • DRUG Trastuzumab
  • DRUG Carboplatin
  • DRUG Docetaxel
  • DRUG Pertuzumab
  • DRUG Trastuzumab Emtansine

Study Locations (20)

California

  • St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr — Fullerton
  • Cancer Care Assoc Med Group — Los Angeles
  • Coastal Integrative Cancer Care — San Luis Obispo
  • Central Coast Medical Oncology — Santa Maria
  • UCLA Hematology/Oncology — Santa Monica

Other

  • UZ Antwerpen — Edegem
  • UZ Leuven Gasthuisberg — Leuven
  • Clinique Saint-Joseph — Liège
  • Clinique Ste-Elisabeth, Pharmacie — Namur

Florida

  • Memorial Cancer Institute — Hollywood
  • Md Anderson Cancer Center Orlando — Orlando

New York

  • ProHEALTH Care Associates LLP — Lake Success
  • Montefiore Medical Center — The Bronx

North Carolina

  • Hope A Women's Cancer Center — Asheville
  • Levine Cancer Institute — Charlotte

Maine

  • New England Cancer Specialists — Scarborough

Nevada

  • Comprehensive Cancer Centers of Nevada - Henderson — Henderson

South Carolina

  • Roper Bon Secours St. Francis Cancer Center — Charleston

Trial Details

FieldValue
Enrollment Target 444 participants
Start Date 2014-06-25
Est. Completion 2018-05-29
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02131064

The ClinicalTrials.gov registry entry for NCT02131064 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 444 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02131064 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02131064 about?

NCT02131064 is a clinical study titled "A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer". This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (\>/=) 2 centimeters (cm). The study was design...

What is the current status of trial NCT02131064?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 444 participants. The study started on 2014-06-25. Estimated completion is 2018-05-29.

What conditions does trial NCT02131064 study?

This clinical trial studies the following conditions: Breast Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02131064?

The interventions under investigation include: Trastuzumab (DRUG), Carboplatin (DRUG), Docetaxel (DRUG), Pertuzumab (DRUG), Trastuzumab Emtansine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02131064?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02131064 being conducted?

This trial has 20 study locations across California, Florida, Maine, Nevada, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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