Trial Outcomes & Findings for Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study (NCT NCT04256941)
NCT ID: NCT04256941
Last Updated: 2024-12-27
Results Overview
Survival curves for PFS will be analyzed using the Kaplan-Meier method and survival difference across groups will be examined by log rank test. Will estimate the treatment comparison with 95% confidence intervals and p-value using Cox proportional hazards regression and we will assess the proportional hazard assumption using graphs of rescaled Schoenfeld residuals and related tests.
TERMINATED
PHASE2
4 participants
Up to 30 days
2024-12-27
Participant Flow
Study was opened to accrual on 5/31/2019. The study was intended for patients with ESR1 mutations. Despite modifications, accrual was poor and the closed to accrual on 8/24/2023
Of the 49 patients screened, 6 patients harbored ESR1 mutation. 4 patients were randomized to the study. 1 patient withdrew consent due to frequent travel/visits after randomization (AI arm). 1 patient was a screen fail due to elevated LFTs, and 1 patient passed away prior to study intervention)
Participant milestones
| Measure |
Fulvestrant
Fulvestrant (Faslodex), a selective estrogen receptor antagonist, was initially indicated for treatment of HR positive MBC in post-menopausal women with disease progression following prior anti-estrogen therapy.
|
Continuing AI After Randomization
CDK inhibitors e.g. palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (verzenio) are approved for the first line treatment of HR positive advanced breast cancers in combination with aromatase inhibitors as well as in combination with fulvestrant with disease progression following prior endocrine therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Fulvestrant
Fulvestrant (Faslodex), a selective estrogen receptor antagonist, was initially indicated for treatment of HR positive MBC in post-menopausal women with disease progression following prior anti-estrogen therapy.
|
Continuing AI After Randomization
CDK inhibitors e.g. palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (verzenio) are approved for the first line treatment of HR positive advanced breast cancers in combination with aromatase inhibitors as well as in combination with fulvestrant with disease progression following prior endocrine therapy.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Disease Progession
|
0
|
2
|
Baseline Characteristics
Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study
Baseline characteristics by cohort
| Measure |
Fulvestrant
n=1 Participants
Fulvestrant (Faslodex), a selective estrogen receptor antagonist, was initially indicated for treatment of HR positive MBC in post-menopausal women with disease progression following prior anti-estrogen therapy.
|
Continuing AI After Randomization
n=3 Participants
CDK inhibitors e.g. palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (verzenio) are approved for the first line treatment of HR positive advanced breast cancers in combination with aromatase inhibitors as well as in combination with fulvestrant with disease progression following prior endocrine therapy.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysPopulation: No data was collected since despite modifications, accrual was poor and the closed. Outcome Measure has zero total analyzed at the protocol specified timepoint.
Survival curves for PFS will be analyzed using the Kaplan-Meier method and survival difference across groups will be examined by log rank test. Will estimate the treatment comparison with 95% confidence intervals and p-value using Cox proportional hazards regression and we will assess the proportional hazard assumption using graphs of rescaled Schoenfeld residuals and related tests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: No data was collected since despite modifications, accrual was poor and the closed. Outcome Measure has zero total analyzed at the protocol specified timepoint.
Graphical analysis, such as scatter plots with Lowess smoothers, will be used to assess the correlative structure of outcomes and compare MAF between fulvestrant and aromatase inhibitor-treated groups. The Pearson correlation, or its non-parametric analogue, the Spearman correlation, will be used to estimate the linear correlation among variables.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: No data was collected since despite modifications, accrual was poor and the closed. Outcome Measure has zero total analyzed at the protocol specified timepoint.
Will be assessed by the secondary resistance of endocrine therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: No data was collected since despite modifications, accrual was poor and the closed. Outcome Measure has zero total analyzed at the protocol specified timepoint.
Will correlate ctDNA with CA 15-3 tumor marker changes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: No data was collected since despite modifications, accrual was poor and the closed. Outcome Measure has zero total analyzed at the protocol specified timepoint.
Survival curves for OS will be analyzed using the Kaplan-Meier method and survival difference across groups will be examined by log rank test. Will estimate the treatment comparison with 95% confidence intervals and p-value using Cox proportional hazards regression and we will assess the proportional hazard assumption using graphs of rescaled Schoenfeld residuals and related tests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: No data was collected since despite modifications, accrual was poor and the closed. Outcome Measure has zero total analyzed at the protocol specified timepoint.
Will be assessed on next line of therapy after progression.
Outcome measures
Outcome data not reported
Adverse Events
Fulvestrant
Continuing AI After Randomization
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fulvestrant
n=1 participants at risk
CDK inhibitors e.g. palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (verzenio) are approved for the first line treatment of HR positive advanced breast cancers in combination with aromatase inhibitors as well as in combination with fulvestrant with disease progression following prior endocrine therapy.
|
Continuing AI After Randomization
n=3 participants at risk
CDK inhibitors e.g. palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (verzenio) are approved for the first line treatment of HR positive advanced breast cancers in combination with aromatase inhibitors as well as in combination with fulvestrant with disease progression following prior endocrine therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • 50 months and 3 weeks
|
33.3%
1/3 • 50 months and 3 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
100.0%
1/1 • 50 months and 3 weeks
|
0.00%
0/3 • 50 months and 3 weeks
|
|
General disorders
Blurred Vision
|
100.0%
1/1 • 50 months and 3 weeks
|
0.00%
0/3 • 50 months and 3 weeks
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • 50 months and 3 weeks
|
0.00%
0/3 • 50 months and 3 weeks
|
|
General disorders
Cough
|
100.0%
1/1 • 50 months and 3 weeks
|
0.00%
0/3 • 50 months and 3 weeks
|
|
Musculoskeletal and connective tissue disorders
Fall
|
100.0%
1/1 • 50 months and 3 weeks
|
0.00%
0/3 • 50 months and 3 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • 50 months and 3 weeks
|
33.3%
1/3 • 50 months and 3 weeks
|
|
Blood and lymphatic system disorders
ALT increased
|
0.00%
0/1 • 50 months and 3 weeks
|
66.7%
2/3 • 50 months and 3 weeks
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase increased
|
0.00%
0/1 • 50 months and 3 weeks
|
33.3%
1/3 • 50 months and 3 weeks
|
|
General disorders
Allergic Rhinitis
|
0.00%
0/1 • 50 months and 3 weeks
|
33.3%
1/3 • 50 months and 3 weeks
|
|
Blood and lymphatic system disorders
AST increased
|
0.00%
0/1 • 50 months and 3 weeks
|
66.7%
2/3 • 50 months and 3 weeks
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
0.00%
0/1 • 50 months and 3 weeks
|
33.3%
1/3 • 50 months and 3 weeks
|
|
Blood and lymphatic system disorders
Hyponatremia
|
100.0%
1/1 • 50 months and 3 weeks
|
33.3%
1/3 • 50 months and 3 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/1 • 50 months and 3 weeks
|
33.3%
1/3 • 50 months and 3 weeks
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
100.0%
1/1 • 50 months and 3 weeks
|
66.7%
2/3 • 50 months and 3 weeks
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
100.0%
1/1 • 50 months and 3 weeks
|
33.3%
1/3 • 50 months and 3 weeks
|
|
General disorders
Vomiting
|
100.0%
1/1 • 50 months and 3 weeks
|
0.00%
0/3 • 50 months and 3 weeks
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
100.0%
1/1 • 50 months and 3 weeks
|
0.00%
0/3 • 50 months and 3 weeks
|
|
Blood and lymphatic system disorders
Creatinine increased
|
100.0%
1/1 • 50 months and 3 weeks
|
33.3%
1/3 • 50 months and 3 weeks
|
Additional Information
Dr. Senthil Damodaran
University of Texas M D Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place