Trial Outcomes & Findings for Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer (NCT NCT04108858)
NCT ID: NCT04108858
Last Updated: 2025-10-01
Results Overview
Incidence of adverse events and serious adverse events to determine safety: incidence of DLTs to determine RP2D
TERMINATED
PHASE1/PHASE2
2 participants
21 days
2025-10-01
Participant Flow
Any participants referred was screened for eligibility. Participants with required mutation were the only participants referred.
No exclusions to report.
Participant milestones
| Measure |
Phase 1, Dose Level 1
Copanlisib 60mg given D1 and D8 over 60mins of each cycle+ trastuzumab, pertuzumab given over 30mins D1 of each cycle all drugs given IV infusion each cycle is 21 days
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Phase 1, Dose Level 1
Copanlisib 60mg given D1 and D8 over 60mins of each cycle+ trastuzumab, pertuzumab given over 30mins D1 of each cycle all drugs given IV infusion each cycle is 21 days
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase 1, Dose Level 1
n=2 Participants
Copanlisib 60mg given D1 and D8 over 60mins of each cycle+ trastuzumab, pertuzumab given over 30mins D1 of each cycle all drugs given IV infusion each cycle is 21 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual. Stopped during Phase 1 portion and did not proceed to Phase 2.
Incidence of adverse events and serious adverse events to determine safety: incidence of DLTs to determine RP2D
Outcome measures
| Measure |
Phase 1, Dose Level 1
n=2 Participants
Copanlisib 60mg given D1 and D8 over 60mins of each cycle+ trastuzumab, pertuzumab given over 30mins D1 of each cycle all drugs given IV infusion each cycle is 21 days
|
Phase II Arm II (Copanlisib, Trastuzumab, Pertuzumab)
Participants receive copanlisib IV over 60 minutes on days 1 and 8. Participants also receive trastuzumab IV over 30-90 minutes and pertuzumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Copanlisib: Given IV Pertuzumab: Given IV Trastuzumab: Given IV
|
|---|---|---|
|
Safety run-in Phase 1b/2
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual. Stopped during Phase 1 portion and did not proceed to Phase 2.
Outcome measures
| Measure |
Phase 1, Dose Level 1
n=2 Participants
Copanlisib 60mg given D1 and D8 over 60mins of each cycle+ trastuzumab, pertuzumab given over 30mins D1 of each cycle all drugs given IV infusion each cycle is 21 days
|
Phase II Arm II (Copanlisib, Trastuzumab, Pertuzumab)
Participants receive copanlisib IV over 60 minutes on days 1 and 8. Participants also receive trastuzumab IV over 30-90 minutes and pertuzumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Copanlisib: Given IV Pertuzumab: Given IV Trastuzumab: Given IV
|
|---|---|---|
|
Incidence of Dose Limiting Toxicities (DLTs) (Phase Ib)
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual. Stopped during Phase 1 portion and did not proceed to Phase 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual. Stopped during Phase 1 portion and did not proceed to Phase 2. We had a total of two participants enrolled in the escalation phase. Patient 1 was on study for 9 weeks and patient 2 was on study for 18 weeks. Study was closed due to poor accrual. No data for analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual. Stopped during Phase 1 portion and did not proceed to Phase 2. We had a total of two participants enrolled in the escalation phase. Since study was prematurely terminated due to poor accrual formal OS analysis could not be performed. No data for analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual. Stopped during Phase 1 portion and did not proceed to Phase 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual. Stopped during Phase 1 portion and did not proceed to Phase 2.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1, Dose Level 1
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1, Dose Level 1
n=2 participants at risk
Copanlisib 60 mg given D1 and D8 of each 21 day cycle +Trastuzumab, pertuzumab given D1 of each 21 day cycle
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
2/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Investigations
aPTT
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Investigations
Alk phos
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Eye disorders
Blurred vision
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Skin and subcutaneous tissue disorders
bruising
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspena
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Gastrointestinal disorders
oral mucositis
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
|
Infections and infestations
Papulopustular
|
50.0%
1/2 • 7 months
This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
|
Additional Information
Dr. Senthil Damodaran, MD. PhD.
University of Texas M D Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60