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Metastatic Breast CancerPhase 2SHERBOCNCT03241810

Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Metastatic Breast Cancer

A Phase 2 study testing Seribantumab and Fulvestrant in people with Metastatic Breast Cancer, run by Elevation Oncology at 59 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative metastatic, unresectable breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Seribantumab and Fulvestrant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
59 sitesin 6 countries
Study dates
15 Aug 2017to 30 Nov 2018
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

  • To be eligible for participation in the study, patients must meet the following criteria. Patients who are HRG negative do not need to complete screening procedures beyond HRG assessment.
  • Patients must have histologically or cytologically confirmed ER+ and/or PR+ (with staining of >1% cells) breast cancer.
  • Patients with confirmed postmenopausal status due to either surgical/natural menopause or ovarian suppression.
  • Patients must be HER2 negative.
  • Patient must have at least one lesion amenable to either core needle biopsy or fine needle aspiration.
  • Patient must have a positive in-situ hybridization (ISH) test for heregulin, as determined by centralized testing of unstained tumor tissue.
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  • Patients that have progressed following at least one but no more than two prior systemic therapies in the locally advanced or metastatic disease setting.
  • Patients with documented progression of locally advanced or metastatic disease as defined by RECISTv1.1 (Exception: patients with bone-only metastatic disease are eligible if they have at least 2 lytic lesions visible on a CT or MRI and have documented disease progression on prior therapy based on the appearance of new lesions).
  • Patients with bone-only lesions who have received radiation to those lesions must have documented progression following radiation therapy.
  • ECOG Performance Score (PS) of 0 or 1.
  • Patients with adequate bone marrow reserves.
  • Adequate hepatic function.
  • Adequate renal function.
  • Patient has recovered from clinically significant effects of any prior, surgery, radiosurgery, or other antineoplastic therapy.
  • Patients who have experienced a venous thromboembolic event within 60 days of signing the main consent form should have been treated with anti-coagulants for at least 7 days prior to beginning treatment and for the duration of treatment on this study.

Who cannot join

  • Patients must meet all the inclusion criteria listed above and none of the following exclusion criteria.
  • Prior treatment with an anti-ErbB3 antibody.
  • Prior treatment with a chemotherapy in the locally advanced or metastatic disease setting.
  • Patients cannot have received prior treatment with fulvestrant or other SERDs in the locally advanced or metastatic setting.
  • Uncontrolled CNS disease or presence of leptomeningeal disease.
  • Inflammatory breast cancer.
Show all 12Show fewer
  • History of another active malignancy that required systemic therapy in the last 2 years. Patients with prior history of in-situ cancer, basal, or squamous cell skin cancer are eligible.
  • Patients with an active infection, or unexplained fever > 38.5 C during screening visits or on the first scheduled day of dosing, which in the investigator's opinion might compromise the patients participation in the trial or affect the study outcome. At the discretion of the investigator, patients with tumor fever may be enrolled.
  • Known hypersensitivity to any of the components of seribantumab, fulvestrant, or who have had hypersensitivity reactions to fully human monoclonal antibodies.
  • NYHA Class III or IV congestive heart failure.
  • Patients with a significant history of cardiac disease (i.e. uncontrolled blood pressure, unstable angina, myocardial infarction within 1 year or ventricular arrhythmias requiring medication) are also excluded.
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; or active human immunodeficiency virus (HIV) infection, active hepatitis B infection or active hepatitis C infection.

Trial locations and contacts

59 sites in 6 countries.

59 sites in 6 countries

United States22 sites

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90404-2131

  • Lahey Clinical Medical Center

    Burlington, Massachusetts, 01805

  • Ironwood Cancer and Research Centers- Chandler

    Chandler, Arizona, 85224

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28207

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • Highland Oncology Group

    Fayetteville, Arkansas, 72703

  • James M Stockman Cancer Institute

    Frederick, Maryland, 21701

  • Saint Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • University of Mississippi

    Jackson, Mississippi, 39216

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • UF Health Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94304

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • University of Utah Health Care - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Holy Cross Hospital Health Center

    Silver Spring, Maryland, 20902

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Saint Helena Hospital

    St. Helena, California, 94574

  • Stamford Hospital

    Stamford, Connecticut, 06902-3628

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Spain15 sites

  • Complejo Hospitalario Universitario La Coruña

    A Coruña, 15006

  • Hospital Teresa Herrera

    A Coruña, 15006

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17007

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramón Y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Son Llatzer

    Palma de Mallorca, 07198

  • Hospital Universitari General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08190

  • De La Cruz Merino, Luis

    Seville, 41009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Miguel Servet

    Zaragoza, 59009

Other trials in Spain

Germany8 sites

  • Medizinisches Zentrum Bonn Friedensplatz

    Bonn, 53111

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Centrum fuer Haematologie und Onkologie Bethanien

    Frankfurt

  • Gynäkologisch-Onkologische Praxis Hannover

    Hanover, 30177

  • Klinikum Rechts der Isar der Technischen Universität München

    München, 81675

  • Rotkreuzklinikum München-Frauenklinik

    Munich, 80637

  • Onkologie Rheinsieg

    Troisdorf, 53840

  • Universitätsklinikum Ulm

    Ulm, 89075

Other trials in Germany

Belgium6 sites

  • Universitair Ziekenhuis Antwerpen

    Antwerp, 2650

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitaire Ziekenhuis Leuven

    Leuven, Vlaams Brabant, 3000

  • Centre Hospitalier de l'Ardenne - Clinique du Sein

    Libramont, Luxembourg, 6800

  • CHU UCL NAMUR - Sainte Elisabeth

    Namur, 5000

  • Clinique Saint-Pierre

    Ottignies, Brabant Wallon, 1340

Other trials in Belgium

Austria4 sites

  • LKH - Universitätsklinikum Graz

    Graz, 8036

  • Universitaetsklinik fuer Gynaekologie und Geburtshilfe

    Innsbruck, 6020

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz, 4010

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Canada4 sites

  • University of Calgary

    Calgary, Alberta, T2S 3C3

  • British Columbia Cancer Agency

    Kelowna, British Columbia, V1Y 5L3

  • McGill University - Jewish General Hospital

    Montreal, H3T 1E2

  • Centre Hospitalier Affilie Universitaire de Quebec

    Québec, G1S 4L8

Other trials in Canada

About this study

Official title: Randomized Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer (Merrimack Pharmaceuticals Inc.)

This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative metastatic, unresectable breast cancer.

Read the detailed description

This study is a randomized, double-blind, placebo-controlled international phase 2 trial in patients with HRG+, HR+, HER2- metastatic breast cancer that has progressed following treatment with no more than 2 prior therapies, one of which must have been a CDK inhibitor. All patients will be screened for heregulin using central testing, and eligible patients will be randomized to receive either seribantumab + fulvestrant or placebo + fulvestrant. Disease status will be assessed according to RECIST v 1.1 to support the primary endpoint.

Being tested
Seribantumab, Fulvestrant, Placebo
Keywords
Breast Cancer, HER2 Negative, Hormone receptor positive
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SeribantumabDrug

    Also called MM-121

    Seribantumab is a human monoclonal antibody that inhibits ErbB3 signalling

  • FulvestrantDrug

    Also called Faslodex

    Fulvestrant is an estrogen receptor antagonist with no agonist effects

  • PlaceboDrug

    Also called Solution containing 20 mM histidine, 150 mM sodium chloride, at a pH of 6.5

    Placebo

Study groups in NCT03241810
Study groupRoleWhat they receive
Arm AExperimentalSeribantumab Fulvestrant
Receives: Drug: Seribantumab; Drug: Fulvestrant
Arm BActive comparatorPlacebo Fulvestrant
Receives: Drug: Fulvestrant; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v1.1 or death from any cause, whichever comes first as assessed by the investigator.

    The tumor assessment (i.e., scan dates) was used for progression/censor date not the date corresponding to the determination of overall response. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.

    Measured: Randomization until progression of disease or death due to any cause up to 13 months (The study terminated prematurely) . The primary analysis was planned to be initiated when 58 PFS events have occurred

Secondary outcomes (6)

  1. Overall Survival

    Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause. The study was terminated on 30 Nov 2018 . Data represents outcomes up to 150 days of treatment.

    Measured: Randomization until death due to any cause up to 13 months (The study terminated prematurely)

  2. Objective Response Rate

    Objective Response Rate (ORR) is defined as the proportion of patients with a RECIST v1.1 response recorded from randomization until disease progression characterized as either a Complete Response (CR) or Partial Response (PR) relative to the total number of evaluable patients.

    Measured: Randomization through end of study up to 13 months (The study terminated prematurely)

  3. Time to Progression

    Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression.

    Measured: Randomization to date of objective tumor progression up to 13 months (The study terminated prematurely)

  4. Number of Participants With Treatment-emergent Adverse Events Reported With the Combinations of Seribantumab Plus Fulvestrant Versus Fulvestrant Alone

    Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration.

    Measured: TEAEs were collected through the study completion (30 Nov 2018), up to 13 months. Frequency and percent summaries were presented for TEAE defined as adverse events that occur or worsen in severity following the first dose of seribantumab, or fulvestrant

  5. Percentage of Treatment-emergent Adverse Events Reported With the Combinations of Seribantumab Plus Fulvestrant Versus Fulvestrant Alone

    Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration.

    Measured: TEAEs were collected through the study completion (30 Nov 2018), up to 13 months. Frequency and percent summaries were presented for TEAE defined as adverse events that occur or worsen in severity following the first dose of seribantumab, or fulvestrant

  6. Pharmacokinetic (PK) Profile of Seribantumab When Given in Combination With Fulvestrant and of Fulvestrant When Given in Combination With Serbantumab.

    Pharmacokinetic (PK) evaluation are performed on samples obtained pre-dose on day 1 and 15 of each 28-day cycle to assess pre-treatment trough concentrations of MM-121. The maximum observed concentration (Cmax) is presented and calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 are measured at a central lab using an enzyme-linked immunosorbent assay (ELISA).

    Measured: The study terminated prematurely after 13 months. Were to be analyzed post-dose on Cycle 1,Week 1 & pre-dose for all subsequent seribantumab infusions until the completion of Cycle 2. Fulvestrant PK samples were to be collected prior to seribantumab dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2017
  2. Study start15 Aug 2017
  3. Primary completion30 Nov 2018
  4. Study completion30 Nov 2018

Why it stopped: Merrimack Inc. terminated the trial early due to business decision

Resources

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
Model description
Patients will be randomized in a 1:1 ratio (experimental arm versus active comparator arm) using an Interactive Web Response System (IWRS). Randomization will be stratified based on bone-only disease (yes, no) and geographic region (US, non-US).
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03241810
Sponsor's protocol ID
MM-121-02-02-10
Other IDs
2017-000565-76, 2017
Acronym
SHERBOC
Status last verified
Nov 2019
First submitted
2 Aug 2017
Last updated
2 Sep 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Seribantumab and Fulvestrant in people with Metastatic Breast Cancer, run by Elevation Oncology at 59 sites in 6 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 15 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Spain, Germany, Belgium, Austria and 1 more country. 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 2 Sep 2020). 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 (time frame: Randomization until progression of disease or death due to any cause up to 13 months (The study terminated prematurely) . The primary analysis was planned to be initiated when 58 PFS events have occurred). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03241810.

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 2 Sep 2020.

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