ER Positive, Her2 Negative Breast Cancer PatientsPhase 2NCT01421472
A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
A Phase 2 study testing MM-121 and Paclitaxel in people with ER Positive, Her2 Negative Breast Cancer Patients and Triple Negative Breast Cancer Patients, run by Merrimack Pharmaceuticals at 38 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- ER Positive, Her2 Negative Breast Cancer Patients, Triple Negative Breast Cancer Patients
- What is being tested?
- MM-121 and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 38 sitesUnited States
- Study dates
- Aug 2011to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL
- Are pregnant or breastfeeding
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Piedmont Healthcare
Altanta, Georgia, 30214
Texas Oncology - Amarillo
Amarillo, Texas, 79106
Texas Oncology-Austin Central
Austin, Texas, 78731
Texas Oncology - Bedford
Bedford, Texas, 76022
Universito of Birmingham atAlabama
Birmingham, Alabama, 35294
Dana-Farber Cancer Institute
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University Of Chicago
Chicago, Illinois, 60637
Texas Oncology - Medical City
Dallas, Texas, 75230
Texas Oncology - Dallas
Dallas, Texas, 75231
Texas Oncology - Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246
Texas Oncology -El Paso
El Paso, Texas, 79902
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214
Texas Oncology - Garland
Garland, Texas, 75042
Marin Cancer Center
Greenbrae, California, 94904
Cancer Center of the Carolinas
Greenville, South Carolina, 29605
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074
Texas Oncology - Memorial City
Houston, Texas, 77024
Memorial Medical Center
Las Cruces, New Mexico, 88011
Texas Oncology - Lewisville
Lewisville, Texas, 75067
Georgia Cancer Specialists
Marietta, Georgia, 30341
Texas Oncology - McAllen
McAllen, Texas, 78503
Illinois Cancer Specialists
Niles, Illinois, 60714
Virginia Oncology Associates
Norfolk, Virginia, 23502
PMK Medical Group
Oxnard, California, 93030
Texas Oncology Plano East
Plano, Texas, 75075-7787
Florida Cancer Research Institute
Plantation, Florida, 33324
Northwest Cancer Specialists
Portland, Oregon, 97225
Wilshire Oncology Medical Group
Rancho Cucamonga, California, 91730
Beaumont Health Systems
Royal Oak, Michigan, 48073
Cancer Care Centers of South Texas
San Antonio, Texas, 78217
Puget Sound Cancer Center
Seattle, Washington, 98133
Arizona Oncology Associates
Tucson, Arizona, 85704
Arizona Oncology Associates
Tuscon, Arizona, 85715
Texas Oncology - Tyler
Tyler, Texas, 75702
Cooper Cancer Institute
Voorhees Township, New Jersey, 08043
Yakima Valley Memorial Hospital
Yakima, Washington, 98902
About this study
Official title: A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
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.
Read the 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.
- Being tested
- MM-121, Paclitaxel
- Keywords
- Breast Cancer, Neoadjuvant, Her2 negative, Her2 non-overexpressing, Estrogen Receptor Positive, Triple Negative, MM-121, Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-121Drug
Also called SAR256212
MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses
PaclitaxelDrug
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
| Study group | Role | What they receive |
|---|---|---|
| MM-121 (SAR256212) + paclitaxel | Experimental | 2 week run-in of MM-121 followed by MM-121 + dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery. Receives: Drug: MM-121; Drug: Paclitaxel |
| Paclitaxel only | Active comparator | Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)
Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was 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.
Measured: At time of surgery, an expected average of 24-26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ER Positive, Her2 Negative Breast Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merrimack Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Victor Moyo, MD, Study director, Merrimack Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421472
- Sponsor's protocol ID
- MM-121-02-02-07 (ARD11918)
- Status last verified
- Mar 2016
- First submitted
- 19 Aug 2011
- Last updated
- 3 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01421472
- Acronym / sponsor ID
- MM-121-02-02-07 (ARD11918)
- Keywords
- Breast Cancer, Neoadjuvant, Her2 negative, Her2 non-overexpressing, Estrogen Receptor Positive, Triple Negative, MM-121, Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Aug 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MM-121 (SAR256212) + paclitaxel | Experimental | Drug: MM-121, Drug: Paclitaxel2 week run-in of MM-121 followed by MM-121 + dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery. |
| Paclitaxel only | Active comparator | Drug: PaclitaxelStandard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL
- Are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MM-121Also: SAR256212MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses | Drug | MM-121 (SAR256212) + paclitaxel |
| PaclitaxelStandard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery. | Drug | MM-121 (SAR256212) + paclitaxel, Paclitaxel only |
Primary outcome
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)
Time frame: At time of surgery, an expected average of 24-26 weeks
Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Moyo, MD study director
Merrimack Pharmaceuticals
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MM-121 and Paclitaxel in people with ER Positive, Her2 Negative Breast Cancer Patients and Triple Negative Breast Cancer Patients, run by Merrimack Pharmaceuticals at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR) (time frame: At time of surgery, an expected average of 24-26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.