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
Public ClinicalTrials.gov record NCT02131064. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02131064
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 444 participants
Conditions and interventions
Conditions
Interventions
- Carboplatin Drug
- Docetaxel Drug
- Pertuzumab Drug
- Trastuzumab Drug
- Trastuzumab Emtansine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 24, 2014
- Primary completion
- Dec 30, 2015
- Completion
- May 28, 2018
- Last update posted
- Jul 1, 2019
2014 – 2018
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr | Fullerton | California | 92835 | — |
| Cancer Care Assoc Med Group | Los Angeles | California | 90095-1772 | — |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93401 | — |
| Central Coast Medical Oncology | Santa Maria | California | 93454 | — |
| UCLA Hematology/Oncology | Santa Monica | California | 90404 | — |
| Memorial Cancer Institute | Hollywood | Florida | 33021 | — |
| Md Anderson Cancer Center Orlando | Orlando | Florida | 32806 | — |
| New England Cancer Specialists | Scarborough | Maine | 04074 | — |
| Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | 89052 | — |
| ProHEALTH Care Associates LLP | Lake Success | New York | 11042 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Hope A Women's Cancer Center | Asheville | North Carolina | 28806 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Roper Bon Secours St. Francis Cancer Center | Charleston | South Carolina | 29414 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02131064, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2019 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02131064 live on ClinicalTrials.gov.