Trial Outcomes & Findings for Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis (NCT NCT00566618)
NCT ID: NCT00566618
Last Updated: 2022-02-25
Results Overview
Objective response rate is defined as the clinical benefit rate (complete and partial response) + stable disease \> 6 months in bone.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
6 months
Results posted on
2022-02-25
Participant Flow
Participants were enrolled and treated on protocol at the three recruiting sites (MD Anderson Cancer, University of Chicago and Duke Cancer Institute).
31 participants enrolled, 25 started treatment and 6 did not receive treatment.
Participant milestones
| Measure |
Phase I Dasatinib (70 mg)
Dasatinib 70 mg twice daily. Zoledronic acid was administered using standard dosing as a 15-minute intravenous infusion on day 1 of a 28-day cycle. Dasatinib was taken orally daily on days 1-28 of the cycle. Dasatinib was given continuously unless patients developed toxicities requiring dose adjustment or treatment interruption.
|
Phase 1 Dasatinib (100 mg)
Dasatinib (100 mg) daily. Zoledronic acid was administered using standard dosing as a 15-minute intravenous infusion on day 1 of a 28-day cycle. Dasatinib was taken orally daily on days 1-28 of the cycle. Dasatinib was given continuously unless patients developed toxicities requiring dose adjustment or treatment interruption.
|
Phase II Drug Administration
Dasatinib 100 mg daily in combination with zoledronic acid 4 mg IV on day 1 of a 28-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
6
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phase I/Phase II
n=25 Participants
PhI/PhII- Dasatinib 70 mg twice daily/ dasatinib 100 mg daily in combination with zoledronic acid 4 mg IV on day 1 of a 28-day cycle.
|
|---|---|
|
Age, Continuous
|
45 years
n=25 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
|
Hormone Receptor
Positive
|
21 Participants
n=25 Participants
|
|
Hormone Receptor
Negative
|
4 Participants
n=25 Participants
|
|
Initial sites of metastases
Bone only
|
17 Participants
n=25 Participants
|
|
Initial sites of metastases
Lung
|
5 Participants
n=25 Participants
|
|
Initial sites of metastases
Lymph nodes
|
4 Participants
n=25 Participants
|
|
Initial sites of metastases
Liver
|
1 Participants
n=25 Participants
|
|
Prior endocrine therapy for metastatic disease
0
|
7 Participants
n=25 Participants
|
|
Prior endocrine therapy for metastatic disease
1
|
15 Participants
n=25 Participants
|
|
Prior endocrine therapy for metastatic disease
>=2
|
3 Participants
n=25 Participants
|
|
Prior chemotherapy for metastatic disease
0
|
23 Participants
n=25 Participants
|
|
Prior chemotherapy for metastatic disease
1
|
2 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT, intent-to-treat analysis of all patients combined. The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The objective response in bone from time to initiation of therapy to \>6 months analysis are combined based on the published article. We have attempted to the best of our ability to locate the data for each phase but we were unsuccessful.
Objective response rate is defined as the clinical benefit rate (complete and partial response) + stable disease \> 6 months in bone.
Outcome measures
| Measure |
Phase I/Phase II
n=25 Participants
PhI/PhII-Open Label dasatinib 100 mg daily in combination with zoledronic acid 4 mg IV on day 1 of a 28-day cycle
|
|---|---|
|
Objective Response in Bone From Time of Initiation of Therapy to > 6 Months
Central Review
|
8 Participants
|
|
Objective Response in Bone From Time of Initiation of Therapy to > 6 Months
Site Review
|
7 Participants
|
PRIMARY outcome
Timeframe: day 1 (+/- 48 hours) prior to therapy during cycle 2 and all subsequent cyclesTo determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for dasatinib in combination with zoledronic acid.
Outcome measures
| Measure |
Phase I/Phase II
n=7 Participants
PhI/PhII-Open Label dasatinib 100 mg daily in combination with zoledronic acid 4 mg IV on day 1 of a 28-day cycle
|
|---|---|
|
Phase I - Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) for Dasatinib in Combination With Zoledronic Acid
Dasatinib
|
100 mg
|
|
Phase I - Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) for Dasatinib in Combination With Zoledronic Acid
zoledronic acid
|
4 mg
|
Adverse Events
Phase I/Phase II
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase I/Phase II
n=25 participants at risk
PhI/PhII-Open Label dasatinib 100 mg daily in combination with zoledronic acid 4 mg IV on day 1 of a 28-day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.0%
3/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
General disorders
Fatigue
|
36.0%
9/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Skin and subcutaneous tissue disorders
Rash
|
36.0%
9/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Gastrointestinal disorders
Nausea
|
24.0%
6/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
General disorders
Pain
|
36.0%
9/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
4.0%
1/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.0%
2/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor symptoms
|
16.0%
4/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.0%
4/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
General disorders
Xerostomia
|
8.0%
2/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
3/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Infections and infestations
Infections (non-neutropenic)
|
12.0%
3/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Skin and subcutaneous tissue disorders
Edema
|
8.0%
2/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
|
Nervous system disorders
Paresthesia
|
12.0%
3/25 • on day 1 (±48 hours) prior to therapy during subsequent cycles, up to 6 months
The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The adverse events are combined based on the published article. We have attempted to the best of our ability to locate the AEs for each phase but we were unsuccessful.
|
Additional Information
Debu Tripathy, Chair, Breast Medical Oncology
UT MD Anderson Cancer Center
Phone: (713) 792-2817
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place