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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03241810
Recruitment Status : Terminated (Merrimack Inc. terminated the trial early due to business decision)
First Posted : August 8, 2017
Results First Posted : September 2, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Elevation Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: Seribantumab
Drug: Fulvestrant
Drug: Placebo
Enrollment 22
Recruitment Details At the time of the study termination by the prior Sponsor (Merrimack Pharmaceuticals), 62 sites participated in the study (27 in North America and 35 in Europe).
Pre-assignment Details  
Arm/Group Title Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Hide Arm/Group Description

Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Period Title: Overall Study
Started 11 11
Completed 11 [1] 11 [1]
Not Completed 0 0
[1]
Safety population: includes patients receiving at least one dose of study medication.
Arm/Group Title Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant Total
Hide Arm/Group Description

Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
Patients that have signed informed consent, identified as HRG positive based on centralized tissue analysis,& have successfully completed study entry criteria (Safety Population- patients receiving at least one dose of study medication).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  72.7%
7
  63.6%
15
  68.2%
>=65 years
3
  27.3%
4
  36.4%
7
  31.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
11
 100.0%
11
 100.0%
22
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
11
 100.0%
11
 100.0%
22
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   9.1%
0
   0.0%
1
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   9.1%
1
   4.5%
White
10
  90.9%
9
  81.8%
19
  86.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   9.1%
1
   4.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Canada 0 1 1
Belgium 2 1 3
United States 5 6 11
Spain 4 3 7
Metastatic burden (TNM Stage at Initial Diagnosis)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
TNM Stage I 0 1 1
TNM Stage II 0 2 2
TNM Stage IIa 4 0 4
TNM Stage IIb 1 0 1
TNM Stage III 0 2 2
TNM Stage IIIa 1 0 1
TNM Stage IIIc 1 0 1
TNM Stage IV 4 6 10
[1]
Measure Description:

Based upon the population treated, the most important baseline measure was CT scans to determine metastatic burden, as the primary endpoint was investigator assessed PFS.

TNM Staging (Tumor size):

T1 (T1a,T1b & T1c): 2 cm (3/4 of an inch) or less across. T2: > 2 cm but not more than 5 cm (2 inches) across. T3: > 5 cm across. T4 (T4a,T4b,T4c,T4d): Tumor of any size growing into the chest wall or skin. As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means cancer has spread more. And within a stage, an earlier letter means a lower stage.

Heregulin positive status and staining in archival tissue   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
11
 100.0%
11
 100.0%
22
 100.0%
[1]
Measure Description: Women had to be ≥ HRG 1+ positive in their submitted tumor sample to qualify for the study
1.Primary Outcome
Title Progression Free Survival
Hide Description

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.

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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population treated up to 150 days
Arm/Group Title Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Hide Arm/Group Description:
Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: Participants
1 1
2.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame Randomization until death due to any cause up to 13 months (The study terminated prematurely)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population treated up to 150 days
Arm/Group Title Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Hide Arm/Group Description:

Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: participants
1 1
3.Secondary Outcome
Title Objective Response Rate
Hide Description 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.
Time Frame Randomization through end of study up to 13 months (The study terminated prematurely)
Hide Outcome Measure Data
Hide Analysis Population Description
Incomplete data for all subjects due to length of time on study treatment and frequency of scanning. All patients analysed had progressive disease. Therefore, they did not meet the criteria for ORR and hence could not be evaluated for CR or PR
Arm/Group Title Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Hide Arm/Group Description:

Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Progression
Hide Description Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression.
Time Frame Randomization to date of objective tumor progression up to 13 months (The study terminated prematurely)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population consisted of all participants randomized to the study.
Arm/Group Title Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Hide Arm/Group Description:

Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Overall Number of Participants Analyzed 11 11
Median (Inter-Quartile Range)
Unit of Measure: days
52
(33.25 to 72.25)
48
(34.50 to 58.50)
5.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events Reported With the Combinations of Seribantumab Plus Fulvestrant Versus Fulvestrant Alone
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: The safety population includes patients receiving at least one dose of study medication. All safety analyses were to be performed on this population.
Arm/Group Title Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Hide Arm/Group Description:

Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: participants
Patients with any TEAE-Related 7 4
Patients with any TEAE-Serious Adverse event 1 0
NCI-CTCAE Grade 3 or Higher 2 1
6.Secondary Outcome
Title Percentage of Treatment-emergent Adverse Events Reported With the Combinations of Seribantumab Plus Fulvestrant Versus Fulvestrant Alone
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population.
Arm/Group Title Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Hide Arm/Group Description:

Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: percentage of adverse events
TEAE-Related 63.6 36.4
TEAE-Serious Adverse event 9.1 0
NCI-CTCAE Grade 3 or Higher 18.2 9.1
7.Secondary Outcome
Title Pharmacokinetic (PK) Profile of Seribantumab When Given in Combination With Fulvestrant and of Fulvestrant When Given in Combination With Serbantumab.
Hide Description 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).
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the premature study termination, the PK data were not collected. There was no pharmacokinetic data feasible for the analysis, and as such, no related analyses were performed. Hence, data could not be reported in the data table.
Arm/Group Title Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Hide Arm/Group Description:

Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From Baseline through to premature study completion up to 13 months (30 Nov 2018)
Adverse Event Reporting Description The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
 
Arm/Group Title Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Hide Arm/Group Description

Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle

Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle

All-Cause Mortality
Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   10/11 (90.91%)      10/11 (90.91%)    
Hide Serious Adverse Events
Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      0/11 (0.00%)    
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/11 (9.09%)  1 0/11 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A (Experimental): Seribantumab and Fulvestrant Arm B (Control): Placebo and Fulvestrant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/11 (90.91%)      8/11 (72.73%)    
Blood and lymphatic system disorders     
Anaemia  1  2/11 (18.18%)  1/11 (9.09%) 
Cardiac disorders     
Palpitations  1  1/11 (9.09%)  0/11 (0.00%) 
Ear and labyrinth disorders     
Ear Pain  1  1/11 (9.09%)  0/11 (0.00%) 
Eye disorders     
Dry eye  1  1/11 (9.09%)  0/11 (0.00%) 
Eye allergy  1  1/11 (9.09%)  0/11 (0.00%) 
Lacrimation increased  1  1/11 (9.09%)  0/11 (0.00%) 
Vision blurred  1  1/11 (9.09%)  0/11 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  7/11 (63.64%)  3/11 (27.27%) 
Nausea  1  2/11 (18.18%)  3/11 (27.27%) 
Dyspepsia  1  3/11 (27.27%)  0/11 (0.00%) 
Oral pain  1  2/11 (18.18%)  1/11 (9.09%) 
Abdominal pain  1  0/11 (0.00%)  2/11 (18.18%) 
Stomatitis  1  2/11 (18.18%)  0/11 (0.00%) 
Constipation  1  0/11 (0.00%)  1/11 (9.09%) 
Dry mouth  1  1/11 (9.09%)  0/11 (0.00%) 
Dysphagia  1  1/11 (9.09%)  0/11 (0.00%) 
Faeces soft  1  0/11 (0.00%)  1/11 (9.09%) 
Odynophagia  1  1/11 (9.09%)  0/11 (0.00%) 
Salivary hypersecretion  1  1/11 (9.09%)  0/11 (0.00%) 
General disorders     
Asthenia  1  3/11 (27.27%)  1/11 (9.09%) 
Fatigue  1  2/11 (18.18%)  1/11 (9.09%) 
Chest discomfort  1  0/11 (0.00%)  1/11 (9.09%) 
Influenza like illness  1  1/11 (9.09%)  0/11 (0.00%) 
Injection site pain  1  0/11 (0.00%)  1/11 (9.09%) 
Injection site reaction  1  0/11 (0.00%)  1/11 (9.09%) 
Malaise  1  0/11 (0.00%)  1/11 (9.09%) 
Pain  1  0/11 (0.00%)  1/11 (9.09%) 
Pyrexia  1  0/11 (0.00%)  1/11 (9.09%) 
Hepatobiliary disorders     
Hepatomegaly  1  1/11 (9.09%)  0/11 (0.00%) 
Infections and infestations     
Urinary tract infection  1  2/11 (18.18%)  1/11 (9.09%) 
Upper respiratory tract infection  1  1/11 (9.09%)  1/11 (9.09%) 
Fungal infection  1  1/11 (9.09%)  0/11 (0.00%) 
Nasopharyngitis  1  1/11 (9.09%)  0/11 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  1/11 (9.09%)  1/11 (9.09%) 
Infusion related reaction  1  0/11 (0.00%)  1/11 (9.09%) 
Investigations     
Aspartate aminotransferase increased  1  0/11 (0.00%)  1/11 (9.09%) 
Blood alkaline phosphatase increased  1  0/11 (0.00%)  1/11 (9.09%) 
Blood bilirubin increased  1  1/11 (9.09%)  0/11 (0.00%) 
Blood lactate dehydrogenase increased  1  0/11 (0.00%)  1/11 (9.09%) 
White blood cell count decreased  1  1/11 (9.09%)  0/11 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  3/11 (27.27%)  5/11 (45.45%) 
Hypokalaemia  1  1/11 (9.09%)  1/11 (9.09%) 
Hypercalcaemia  1  1/11 (9.09%)  0/11 (0.00%) 
Hyperchloraemia  1  1/11 (9.09%)  0/11 (0.00%) 
Hyperuricaemia  1  0/11 (0.00%)  1/11 (9.09%) 
Hypocalcaemia  1  0/11 (0.00%)  1/11 (9.09%) 
Hypomagnesaemia  1  1/11 (9.09%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/11 (18.18%)  1/11 (9.09%) 
Back pain  1  1/11 (9.09%)  1/11 (9.09%) 
Bone pain  1  1/11 (9.09%)  1/11 (9.09%) 
Musculoskeletal pain  1  2/11 (18.18%)  0/11 (0.00%) 
Flank pain  1  1/11 (9.09%)  0/11 (0.00%) 
Groin pain  1  1/11 (9.09%)  0/11 (0.00%) 
Joint swelling  1  0/11 (0.00%)  1/11 (9.09%) 
Muscle spasms  1  1/11 (9.09%)  0/11 (0.00%) 
Myalgia  1  0/11 (0.00%)  1/11 (9.09%) 
Neck pain  1  0/11 (0.00%)  1/11 (9.09%) 
Pain in extremity  1  1/11 (9.09%)  0/11 (0.00%) 
Pain in jaw  1  0/11 (0.00%)  1/11 (9.09%) 
Nervous system disorders     
Dysgeusia  1  2/11 (18.18%)  1/11 (9.09%) 
Headache  1  2/11 (18.18%)  0/11 (0.00%) 
Hypoaesthesia  1  1/11 (9.09%)  1/11 (9.09%) 
Paraesthesia  1  1/11 (9.09%)  0/11 (0.00%) 
Psychiatric disorders     
Depression  1  0/11 (0.00%)  1/11 (9.09%) 
Irritability  1  1/11 (9.09%)  0/11 (0.00%) 
Renal and urinary disorders     
Dysuria  1  1/11 (9.09%)  1/11 (9.09%) 
Urine odour abnormal  1  0/11 (0.00%)  1/11 (9.09%) 
Reproductive system and breast disorders     
Vulvovaginal pruritus  1  1/11 (9.09%)  0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  2/11 (18.18%)  1/11 (9.09%) 
Cough  1  1/11 (9.09%)  1/11 (9.09%) 
Epistaxis  1  1/11 (9.09%)  0/11 (0.00%) 
Nasal dryness  1  1/11 (9.09%)  0/11 (0.00%) 
Oropharyngeal pain  1  0/11 (0.00%)  1/11 (9.09%) 
Pleural effusion  1  0/11 (0.00%)  1/11 (9.09%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  2/11 (18.18%)  0/11 (0.00%) 
Alopecia  1  1/11 (9.09%)  0/11 (0.00%) 
Dry skin  1  1/11 (9.09%)  0/11 (0.00%) 
Pain of skin  1  1/11 (9.09%)  0/11 (0.00%) 
Rash  1  0/11 (0.00%)  1/11 (9.09%) 
Rash maculo-papular  1  1/11 (9.09%)  0/11 (0.00%) 
Vascular disorders     
Hot flush  1  2/11 (18.18%)  0/11 (0.00%) 
Jugular vein thrombosis  1  0/11 (0.00%)  1/11 (9.09%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Sponsor (Merrimack Pharmaceuticals, INC.) terminated the trial early due to business decision
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP, Clinical Operations
Organization: Elevation oncology
Phone: +1-716 371 1125
EMail: clinical@elevationoncology.com
Layout table for additonal information
Responsible Party: Elevation Oncology
ClinicalTrials.gov Identifier: NCT03241810    
Other Study ID Numbers: MM-121-02-02-10
2017-000565-76 ( EudraCT Number )
First Submitted: August 2, 2017
First Posted: August 8, 2017
Results First Submitted: July 20, 2020
Results First Posted: September 2, 2020
Last Update Posted: September 2, 2020