Her2 Negative Breast Cancer PatientsPhase 2NCT01151046
Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer
A Phase 2 study testing MM-121 and Exemestane in people with Her2 Negative Breast Cancer Patients, run by Merrimack Pharmaceuticals at 33 sites in 5 countries.
Trial summary
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Her2 Negative Breast Cancer Patients
- What is being tested?
- MM-121 and Exemestane
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 33 sitesin 5 countries
- Study dates
- Jun 2010to Sep 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
- Locally advanced or metastatic breast cancer
- Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer
- ≥ 18 years of age
Who cannot join
- Received prior treatment with exemestane
- Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)
- Symptomatic CNS disease
Trial locations and contacts
33 sites in 5 countries.
33 sites in 5 countries
United States18 sites
Pacific Cancer Medical Center
Anaheim, California, 92801
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Achieve Clinical Research
Birmingham, Alabama, 35209
Achieve Clinical Research
Birmingham, Alabama, 35216
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rush University Medical Center
Chicago, Illinois, 60612
Wilshire Oncology Medical Group, Inc.
Corona, California, 92879
Southwest Cancer Center
Escondido, California, 92025
Arizona Center for Cancer Care
Glendale, Arizona, 85306
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical Research
Knoxville, Tennessee, 37909
Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical Research
Knoxville, Tennessee, 37909
Horizon Oncology Center
Lafayette, Indiana, 47905
Pasco-Pinellas Oncology
New Port Richey, Florida, 34652
Hematology Oncology Associates, INC.
Oakland, California, 94609
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
San Jose Medical Center
San Jose, California, 95124
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
Spain5 sites
Vall d'Hebrón University Hospital
Barcelona, 8035
Hospital Clinic (Barcelona)
Barcelona, 8036
Hospital Parc Tauli - Barcelona
Barcelona, 8208
Servicio de Oncología Médica / Hospital Universitario Gregorio Marañón
Madrid, 28007
Puerta de Hierro
Madrid, 28220
Canada4 sites
Hopital Maissoneuve-Rosemont
Montreal, Quebec, H1T2M4
McGill University Jewish General Hospital
Montreal, Quebec, H3T 1E2
Hopital du Sacre-Coeur de Montreal
Montreal, H4J 1C5
CHA St. Sacrement
Québec, G1S 4L8
Russia4 sites
Medico-Diagnostically Center of International Institution of biological systems n.a.S.M.
Berezina
Railway Clinical Hospital
Saint Petersburg, 125271
Leningrad Regional Oncology Center
Saint Petersburg, 188663
City Clinical Oncology Center
Saint Petersburg, 197022
Germany2 sites
Onkogologisches zentrum Munich
Munich, 80836
Brustzentrum HS Kliniken Wiesbaden
Wiesbaden, 65189
About this study
Official title: A Randomized Double-Blind Phase 2 Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive (ER+) and/or Progesterone Receptor Positive (PR+) Her2 Negative Breast Cancer
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone
Read the detailed description
The study is a double-blind, randomized Phase 2 trial of Exemestane +/- MM-121. The trial is designed to demonstrate whether MM-121 + Exemestane is more effective than Exemestane alone in ER+ and/or PR+ and Her2 negative breast cancer patients that have failed first-line anti-estrogen therapy in the locally advanced or metastatic setting and patients that have progressed during (or within 6 months of completing) adjuvant treatment with a non-steroidal aromatase inhibitor (AI)and/or tamoxifen. Patients will be treated until radiologic or clinical progression of their disease is documented. Local radiologist and/or PI assessment is accepted.
- Conditions
- Her2 Negative Breast Cancer Patients
- Being tested
- MM-121, Placebo, Exemestane
- Keywords
- Breast Cancer, Her2 negative, Estrogen Receptor Positive, Progesterone Receptor Positive, MM-121, Exemestane, Postmenopausal Women
- 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 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week
PlaceboDrug
Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day
ExemestaneDrug
Also called Aromasin
Exemestane (25 mg) administered orally once per day
| Study group | Role | What they receive |
|---|---|---|
| MM-121 (SAR256212) + exemestane | Experimental | Not described Receives: Drug: MM-121; Drug: Exemestane |
| Placebo + exemestane | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
Measured: Time from first dose to date of progression, the longest time frame of 79.1 weeks
Secondary outcomes (1)
Overall Survival
To determine whether MM-121 + exemestane is more effective than placebo + exemestane in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.
Measured: Time from first dose to date of death, over approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2014
- Study completionSep 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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merrimack Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor Moyo, MD, Study director, Merrimack Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151046
- Sponsor's protocol ID
- MM-121-02-02-03 (ARD11588)
- Status last verified
- Apr 2016
- First submitted
- 24 Jun 2010
- Last updated
- 12 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 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Phase 2 Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive (ER+) and/or Progesterone Receptor Positive (PR+) Her2 Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01151046
- Acronym / sponsor ID
- MM-121-02-02-03 (ARD11588)
- Conditions
- Her2 Negative Breast Cancer Patients
- Keywords
- Breast Cancer, Her2 negative, Estrogen Receptor Positive, Progesterone Receptor Positive, MM-121, Exemestane, Postmenopausal Women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Posted 12 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone
Detailed description
The study is a double-blind, randomized Phase 2 trial of Exemestane +/- MM-121. The trial is designed to demonstrate whether MM-121 + Exemestane is more effective than Exemestane alone in ER+ and/or PR+ and Her2 negative breast cancer patients that have failed first-line anti-estrogen therapy in the locally advanced or metastatic setting and patients that have progressed during (or within 6 months of completing) adjuvant treatment with a non-steroidal aromatase inhibitor (AI)and/or tamoxifen. Patients will be treated until radiologic or clinical progression of their disease is documented. Local radiologist and/or PI assessment is accepted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MM-121 (SAR256212) + exemestane | Experimental | Drug: MM-121, Drug: Exemestane |
| Placebo + exemestane | Placebo comparator | Drug: Placebo, Drug: Exemestane |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Locally advanced or metastatic breast cancer
- Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer
- ≥ 18 years of age
Key exclusion criteria (3 listed)
- Received prior treatment with exemestane
- Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)
- Symptomatic CNS disease
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 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week | Drug | MM-121 (SAR256212) + exemestane |
| PlaceboPlacebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day | Drug | Placebo + exemestane |
| ExemestaneAlso: AromasinExemestane (25 mg) administered orally once per day | Drug | MM-121 (SAR256212) + exemestane, Placebo + exemestane |
Primary outcome
Progression Free Survival (PFS)
Time frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks
To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
1 secondary outcome
Overall Survival
Time frame: Time from first dose to date of death, over approximately 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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, Inc.
33 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MM-121 and Exemestane in people with Her2 Negative Breast Cancer Patients, run by Merrimack Pharmaceuticals at 33 sites in 5 countries.
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 3 inclusion and 3 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 12 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 33 sites in United States, Spain, Canada, Russia, Germany. 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. Some participants in this study may receive a placebo. 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 12 May 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?
Progression Free Survival (PFS) (time frame: Time from first dose to date of progression, the longest time frame of 79.1 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 12 May 2016.