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NCT02131064 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Breast Neoplasms, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 444
- Enrollment target
- 20
- Study locations
NCT02131064: Completed Phase 3 study of Breast Neoplasms, sponsored by Hoffmann-La Roche.
NCT02131064 is a Phase 3 study of Breast Neoplasms that has completed, run by Hoffmann-La Roche. The registered enrollment target is 444 participants, below the 564-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02131064, a Phase 3 study of Breast Neoplasms, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 444 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
tpCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( that is \[i.e.\], ypT0/is, ypN0 in the American Joint Committee on Cancer \[AJCC\] staging system, 7th edition). Percentage of participants with tpCR was reported.
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
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2014-06-25 |
| Est. Completion | 2018-05-29 |
| Phase | Phase 3 |
What the finished NCT02131064 record still lists
NCT02131064 is an interventional study that assigns participants to a tested intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap, below the 564-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (21% lower).
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.
NCT02131064 names 20 study sites across 10 states, led by California, Other, Florida.
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.
What interventions are being tested in trial NCT02131064?
The interventions under investigation include: Trastuzumab (DRUG), Carboplatin (DRUG), Docetaxel (DRUG), Pertuzumab (DRUG), Trastuzumab Emtansine (DRUG).
Who is sponsoring clinical trial NCT02131064?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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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 NCT02131064's enrollment target sits among peer trials
444 24th of 97 higher than 74 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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.
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