A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer
Public ClinicalTrials.gov record NCT02370238. 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, Double-blind, Placebo-controlled Phase 2 Study of Paclitaxel in Combination With Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple- Negative Breast Cancer (FRIDA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Objectives of this study: The primary objective of the study was to evaluate progression-free survival (PFS) (defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, as assessed by Independent Radiology Review, or death for any cause, whichever occured first) in patients with metastatic triple-negative breast cancer (TNBC) treated with the combination of paclitaxel and orally administered reparixin compared to paclitaxel alone. The secondary objectives were: * To determine overall survival (OS). * To evaluate objective response rates (ORR). * To determine median PFS (mPFS). * To assess the safety of the combination of paclitaxel and orally administered reparixin (referred to as combination treatment).
Study identification
- NCT ID
- NCT02370238
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 194 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- 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
- Jul 29, 2015 (Actual)
- Primary completion
- Feb 20, 2019 (Actual)
- Completion
- Mar 23, 2020 (Actual)
- Last update posted
- Sep 16, 2022
2015 – 2020
United States locations
- U.S. sites
- 32
- U.S. states
- 13
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Cancer Center | Mobile | Alabama | 36608 | — |
| CBCC Global Research a Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | — |
| Florida Cancer Specialists | Daytona Beach | Florida | 32117 | — |
| Florida Cancer Specialists | West Palm Beach | Florida | 33401 | — |
| Atlanta Cancer Care | Alpharetta | Georgia | 30005 | — |
| Northside Hospital, Inc.-Georgia Cancer Specialists | Athens | Georgia | 30606 | — |
| Atlanta Cancer Care | Atlanta | Georgia | 30342 | — |
| Northside Hospital, Inc. | Atlanta | Georgia | 30342 | — |
| Northside Hospital, Inc.-Georgia Cancer Specialists | Canton | Georgia | 30114 | — |
| Atlanta Cancer Care | Conyers | Georgia | 30094 | — |
| Atlanta Cancer Care | Cumming | Georgia | 30041 | — |
| Atlanta Cancer Care | Decatur | Georgia | 30033 | — |
| Northside Hospital, Inc.-Georgia Cancer Specialists | Decatur | Georgia | 30033 | — |
| Atlanta Cancer Care | Jonesboro | Georgia | 30236 | — |
| Northside Hospital, Inc.-Georgia Cancer Specialists | Macon | Georgia | 31217 | — |
| Northside Hospital, Inc.-Georgia Cancer Specialists | Marietta | Georgia | 30060 | — |
| Southeastern Regional Medical Center | Newnan | Georgia | 30265 | — |
| Northside Hospital, Inc.-Georgia Cancer Specialists | Sandy Springs | Georgia | 30342 | — |
| Swedish Covenant | Chicago | Illinois | 60625 | — |
| Mid Illinois Hematology & Oncology Associates, Ltd. | Normal | Illinois | 61761 | — |
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Summit Medical Group | Morristown | New Jersey | 07960 | — |
| Regional Cancer Care Associates | Sparta | New Jersey | 07871 | — |
| Waverly Hematology Oncology | Cary | North Carolina | 27518 | — |
| Hematology and Oncology Associates of Northeast PA | Dunmore | Pennsylvania | 18512 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Tennessee Oncology PLLC | Chattanooga | Tennessee | 37404 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| The Methodist Hospital | Houston | Texas | 77030 | — |
| Overlake Medical Center | Bellevue | Washington | 98004 | — |
| Fox Valley Hematology and Oncology, SC | Appleton | Wisconsin | 54915 | — |
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 45 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02370238, 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 Sep 16, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02370238 live on ClinicalTrials.gov.