A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
This study is currently recruiting participants.
Verified February 2013 by Merrimack Pharmaceuticals
Sponsor:
Merrimack Pharmaceuticals
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01421472
First received: August 19, 2011
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative locally advanced operable breast cancer patients.
| Condition | Intervention | Phase |
|---|---|---|
|
ER Positive, Her2 Negative Breast Cancer Patients Triple Negative Breast Cancer Patients |
Drug: MM-121 (SAR256212) plus paclitaxel Drug: Paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Paclitaxel
U.S. FDA Resources
Further study details as provided by Merrimack Pharmaceuticals:
Primary Outcome Measures:
- To determine the pathologic Complete Response (pCR) rate [ Time Frame: At time of surgery, an expected average of 24-26 weeks ] [ Designated as safety issue: No ]To determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: MM-121 (SAR256212) + paclitaxel |
Drug: MM-121 (SAR256212) plus paclitaxel
Treatment of MM-121 (SAR256212) IV plus standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
|
| Active Comparator: Paclitaxel only |
Drug: Paclitaxel
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
|
Detailed Description:
This is a multicenter, open-label, randomized, Phase II study of preoperative MM-121 with paclitaxel in HER2-negative breast cancer. Patients will be randomized to receive paclitaxel with or without MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus cyclophosphamide and subsequent surgery.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histological confirmation of ER positive, HER2 negative invasive breast cancer (Group 1) or invasive triple-negative breast cancer (Group 2)
- Free of metastatic disease
- ≥ 18 years old
- Female
- Had no prior treatment for any cancer
- Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide
Exclusion Criteria:
- Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL
- Are pregnant or breastfeeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421472
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| United States, Alabama | |
| Universito of Birmingham atAlabama | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Liz Busby, RN, BSN 205-934-0337 lizbusby@uab.edu | |
| United States, Arizona | |
| Arizona Oncology Associates | Recruiting |
| Tucson, Arizona, United States, 85704 | |
| Contact: Julie Klinker julie.klinker@usoncology.com | |
| Arizona Oncology Associates | Recruiting |
| Tuscon, Arizona, United States, 85715 | |
| Contact: Cynthia Montgomery 520-290-2510 cynthia.montgomery@usoncology.com | |
| United States, California | |
| Marin Cancer Center | Recruiting |
| Greenbrae, California, United States, 94904 | |
| Contact: Jaime Chang jchang@marinspecialtycare.com | |
| PMK Medical Group | Recruiting |
| Oxnard, California, United States, 93030 | |
| Contact: Manuel Marquez mmarquez@venturaoncology.com | |
| Wilshire Oncology Medical Group | Recruiting |
| Rancho Cucamonga, California, United States, 91730 | |
| Contact: Lilia Jaramillo-Paloma lilia.jaramillo-paloma@usoncology.com | |
| United States, Florida | |
| Florida Cancer Research Institute | Recruiting |
| Plantation, Florida, United States, 33324 | |
| Contact: Dina Hussein 954-582-1850 crc@flcancercare.com | |
| United States, Georgia | |
| Piedmont Healthcare | Recruiting |
| Altanta, Georgia, United States, 30214 | |
| Contact: Michelle Humphreys michelle.humphreys@piedmont.org | |
| Piedmont Fayette Hospital | Recruiting |
| Fayetteville, Georgia, United States, 30214 | |
| Contact: Anita Smith ASmith@phoc.com | |
| Georgia Cancer Specialists | Recruiting |
| Marietta, Georgia, United States, 30341 | |
| Contact: Christopher Moore Christopher.Moore@gacancer.com | |
| United States, Illinois | |
| University Of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Bernadette Libao blibao@medicine.bsd.uchicago.edu | |
| Illinois Cancer Specialists | Recruiting |
| Niles, Illinois, United States, 60714 | |
| Contact: Lisbeth Lynn lisbeth.lynn@usoncology.com | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Hannah Potler hpotler@partners.org | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Marissa Frongillo 617-724-7578 mfrongillo@partners.org | |
| United States, Michigan | |
| Beaumont Health Systems | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Stacey Sitarek 248-551-6913 ssitarek@beaumont.edu | |
| United States, Nevada | |
| Comprehensive Cancer Centers of Nevada | Recruiting |
| Henderson, Nevada, United States, 89074 | |
| Contact: Barbara Abeytia barbara.abeytia@usoncology.com | |
| United States, New Jersey | |
| Cooper Cancer Institute | Recruiting |
| Voorhees, New Jersey, United States, 08043 | |
| Contact: Kim Krieger krieger-kimberly@cooperhealth.edu | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Contact: Ann Parsons aparsons@salud.unm.edu | |
| Memorial Medical Center | Recruiting |
| Las Cruces, New Mexico, United States, 88011 | |
| Contact: Kim Hoffman kim.hoffman@lpnt.net | |
| United States, Oregon | |
| Northwest Cancer Specialists | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Margaret Bigler margaret.bigler@usoncology.com | |
| United States, South Carolina | |
| Cancer Center of the Carolinas | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Gina Norris gina.norris@usoncology.com | |
| United States, Texas | |
| Texas Oncology - Amarillo | Recruiting |
| Amarillo, Texas, United States, 79106 | |
| Contact: John McMahan john.mcmahan@usoncology.com | |
| Texas Oncology-Austin Central | Recruiting |
| Austin, Texas, United States, 78731 | |
| Contact: Lauren Hendrix 512-341-8724 lauren.hendrix@usoncology.com | |
| Texas Oncology - Bedford | Recruiting |
| Bedford, Texas, United States, 76022 | |
| Contact: Cynthia Schoenfeldt cindi.schoenfeldt@usoncology.com | |
| Texas Oncology - Baylor Charles A Sammons Cancer Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Marnie Fisher marnie.fisher@usoncology.com | |
| Texas Oncology - Medical City | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Rhonda Waldrop 972-566-4291 rhonda.waldrop@usoncology.com | |
| Texas Oncology - Dallas | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact: Kaylene Smith Kaylene.smith@usoncology.com | |
| Texas Oncology -El Paso | Recruiting |
| El Paso, Texas, United States, 79902 | |
| Contact: Noemi Salcido noemi.salcido@usoncology.com | |
| Texas Oncology - Garland | Recruiting |
| Garland, Texas, United States, 75042 | |
| Contact: Donna Mitchell donna.mitchell@usoncology.com | |
| Texas Oncology - Memorial City | Recruiting |
| Houston, Texas, United States, 77024 | |
| Contact: Amber Mendoza amber.mendoza@usoncology.com | |
| Texas Oncology - Lewisville | Recruiting |
| Lewisville, Texas, United States, 75067 | |
| Contact: Yanisca Boleware elle.boleware@usoncology.com | |
| Texas Oncology - McAllen | Recruiting |
| McAllen, Texas, United States, 78503 | |
| Contact: Katia Moreno katia.moreno@usoncology.com | |
| Texas Oncology Plano East | Recruiting |
| Plano, Texas, United States, 75075-7787 | |
| Contact: Kristy Lee kristy.lee@usoncology.com | |
| Cancer Care Centers of South Texas | Recruiting |
| San Antonio, Texas, United States, 78217 | |
| Contact: Elizabeth Guthrie elizabeth.guthrie@usoncology.com | |
| Texas Oncology - Tyler | Recruiting |
| Tyler, Texas, United States, 75702 | |
| Contact: Linda Dunkin 903-579-9800 linda.dunkin@usoncology.com | |
| United States, Virginia | |
| Virginia Oncology Associates | Recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Contact: Wendi Gobhardt wendi.gobhardt@usoncology.com | |
| United States, Washington | |
| Puget Sound Cancer Center | Recruiting |
| Seattle, Washington, United States, 98133 | |
| Contact: Navid Nikoo 206-365-8252 navid.nikoo@swedish.org | |
| Yakima Valley Memorial Hospital | Recruiting |
| Yakima, Washington, United States, 98902 | |
| Contact: Beth Parker bethparker@yvmh.com | |
Sponsors and Collaborators
Merrimack Pharmaceuticals
Sanofi
Investigators
| Study Director: | Victor Moyo, MD | Merrimack Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Merrimack Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01421472 History of Changes |
| Other Study ID Numbers: | MM-121-02-02-07 (ARD11918) |
| Study First Received: | August 19, 2011 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merrimack Pharmaceuticals:
|
Breast Cancer Neoadjuvant Her2 negative Her2 non-overexpressing |
Estrogen Receptor Positive Triple Negative MM-121 Paclitaxel |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013