Trial Outcomes & Findings for 1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over. (NCT NCT02000596)
NCT ID: NCT02000596
Last Updated: 2022-05-27
Results Overview
Defined as the total of complete response (CR) defined as a disappearance of all target lesions, partial response (PR) defined as \>= 30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) \>= 27 weeks among the total number of participants as defined by the Response Evaluation in Solid Tumors (RECIST) 1.1 response criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Participants were staged every two cycles for the duration of the study participation ( CR+PR+SD=ORR), up to 11 months
Results posted on
2022-05-27
Participant Flow
Participant milestones
| Measure |
Cohort 1: T+P
Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
Trastuzumab plus Pertuzumab
|
Cohort 2 - Arm A
Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +
Trastuzumab plus Pertuzumab
Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
|
Cohort 2 - Arm B
Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
Trastuzumab plus Pertuzumab
Chemotherapy with Eribulin
|
|---|---|---|---|
|
Cohort 1
STARTED
|
2
|
0
|
0
|
|
Cohort 1
COMPLETED
|
2
|
0
|
0
|
|
Cohort 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Cohort 2
STARTED
|
0
|
0
|
2
|
|
Cohort 2
COMPLETED
|
0
|
0
|
2
|
|
Cohort 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.
Baseline characteristics by cohort
| Measure |
Cohort 1: T+P
n=2 Participants
Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
Trastuzumab plus Pertuzumab
|
Cohort 2 - Arm A
Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +
Trastuzumab plus Pertuzumab
Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
|
Cohort 2 - Arm B
Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
Trastuzumab plus Pertuzumab
Chemotherapy with Eribulin
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White/ Non-Hispanic
|
2 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
—
|
—
|
2 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Participants were staged every two cycles for the duration of the study participation ( CR+PR+SD=ORR), up to 11 monthsPopulation: Participants started in "Cohort 1: T+P" Arm/Group and continued in "Cohort 2 Arm B" due to progressive disease
Defined as the total of complete response (CR) defined as a disappearance of all target lesions, partial response (PR) defined as \>= 30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) \>= 27 weeks among the total number of participants as defined by the Response Evaluation in Solid Tumors (RECIST) 1.1 response criteria.
Outcome measures
| Measure |
Cohort 1: T+P
n=2 Participants
Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
Trastuzumab plus Pertuzumab
|
Cohort 2 - Arm A
Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +
Trastuzumab plus Pertuzumab
Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
|
Cohort 2 - Arm B
n=2 Participants
Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
Trastuzumab plus Pertuzumab
Chemotherapy with Eribulin
|
|---|---|---|---|
|
Overall Response Rate (ORR) in Patients
Complete Response (CR)
|
0 Participants
|
—
|
0 Participants
|
|
Overall Response Rate (ORR) in Patients
Partial Response (PR)
|
1 Participants
|
—
|
0 Participants
|
|
Overall Response Rate (ORR) in Patients
Stable Disease (SD)
|
1 Participants
|
—
|
2 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 monthsPopulation: No participants were enrolled in Cohort 2- Arm A
Progression Free Survival in treatment cohorts 1 and 2 as well as arms A and B from the time on study until progression of disease or death
Outcome measures
| Measure |
Cohort 1: T+P
n=2 Participants
Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
Trastuzumab plus Pertuzumab
|
Cohort 2 - Arm A
Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +
Trastuzumab plus Pertuzumab
Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
|
Cohort 2 - Arm B
n=2 Participants
Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
Trastuzumab plus Pertuzumab
Chemotherapy with Eribulin
|
|---|---|---|---|
|
Progression-free Survival (PFS)
Subject 1
|
6 weeks
|
—
|
12 weeks
|
|
Progression-free Survival (PFS)
Subject 2
|
24 weeks
|
—
|
24 weeks
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion, an average of 2 years.Population: Participants started in "Cohort 1: T+P" Arm/Group and continued in "Cohort 2 Arm B" due to progressive disease. The analysis below reflects Cohort 2 only
Overall survival (OS) in treatment cohorts 1 and 2 as well as arms A and B from the time on study until death
Outcome measures
| Measure |
Cohort 1: T+P
Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
Trastuzumab plus Pertuzumab
|
Cohort 2 - Arm A
Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +
Trastuzumab plus Pertuzumab
Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
|
Cohort 2 - Arm B
n=2 Participants
Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
Trastuzumab plus Pertuzumab
Chemotherapy with Eribulin
|
|---|---|---|---|
|
Overall Survival (OS)
Subject 1
|
—
|
—
|
25 Months
|
|
Overall Survival (OS)
Subject 2
|
—
|
—
|
14 Months
|
SECONDARY outcome
Timeframe: Participants were followed during the study and for 30 days after completion of the study treatment, up to 12 monthsPopulation: No participants were enrolled in Cohort 2- Arm A
the safety and tolerability of Trastuzumab and Pertuzumab alone and in combination with hormonal therapy or single agent chemotherapy. in HER2+ MBC patients
Outcome measures
| Measure |
Cohort 1: T+P
n=2 Participants
Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
Trastuzumab plus Pertuzumab
|
Cohort 2 - Arm A
Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +
Trastuzumab plus Pertuzumab
Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
|
Cohort 2 - Arm B
n=2 Participants
Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
Trastuzumab plus Pertuzumab
Chemotherapy with Eribulin
|
|---|---|---|---|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
participant 1
|
5 participants
|
—
|
2 participants
|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
participant 2
|
5 participants
|
—
|
8 participants
|
SECONDARY outcome
Timeframe: Duration of study, participants were followed every cycle up to 11 months.Population: Two patients were enrolled, no data was analyzed.
quality of life and treatment side effects via patient-reported and investigator reported outcomes
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: T+P
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Cohort 2 - Arm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2 - Arm B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: T+P
n=2 participants at risk
Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
Trastuzumab plus Pertuzumab
|
Cohort 2 - Arm A
Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +
Trastuzumab plus Pertuzumab
Hormonal Therapy with Anastrozole and Fulvestrant: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
|
Cohort 2 - Arm B
n=2 participants at risk
Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
Trastuzumab plus Pertuzumab
Chemotherapy with Eribulin
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
muscle aches or neck aches
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
Nervous system disorders
smell aversion
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
Hepatobiliary disorders
elevated AST
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
Hepatobiliary disorders
elevated ALT
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
General disorders
Fatigue
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
General disorders
Rigors
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
Nervous system disorders
Paresthia
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
Gastrointestinal disorders
Reflux
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
|
Gastrointestinal disorders
Taste Changes
|
0.00%
0/2 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
—
0/0 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
50.0%
1/2 • Number of events 1 • up to 24 months
There were no participants enrolled in Cohort 2 - Arm A, therefore, the at risk population for all-cause mortality, SAEs, and AEs are zero.
|
Additional Information
Kate Tkaczuk
University of Maryland Greenebaum Comprehensive Cancer Center
Phone: 410-328-7394
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place