Breast CancerPhase 1/2NCT00566618
Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis
A Phase 1/2 study testing Dasatinib and Zoledronic Acid in people with Breast Cancer and Bone Metastases, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of dasatinib and Zometa (zoledronic acid) that can be given in combination for the treatment of breast cancer that has spread to the bone. The safety and effectiveness of this combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Bone Metastases
- What is being tested?
- Dasatinib and Zoledronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2007to 17 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a pathologically confirmed diagnosis of invasive carcinoma of the breast.
- Patients must carry a diagnosis of metastatic breast cancer with predominant bone involvement. For the purposes of this study, predominant bone involvement will be defined as radiographically detected bone metastasis in the presence or absence of other sites of metastatic breast cancer (i.e. visceral involvement). If visceral involvement is present, patients must be asymptomatic and have no tumors in visceral organs that measure >3cm in size.
- Patients must agree to serial urine collections for measurement of Ntx.
- Age >/= 18 years.
- Patients must be able to swallow oral medications. Dasatinib must be taken whole and cannot be crushed.
- Patients must have evaluable disease using WHO Criteria for Assessment of Disease Response in Bone or MDACC Modified Response Criteria for Assessment of Disease Response in Bone.
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- Patients must not have had >1 chemotherapy regimens for metastatic disease. Patients with metastasis diagnosed </= 6 months after completion of adjuvant chemotherapy are considered to have had chemotherapy for metastatic breast cancer.
- Patients with ER positive disease must have had disease progression on at least one prior hormonal therapy for metastatic disease. Patients must also have developed disease progression on their most recent hormonal therapy regimen and be agreeable to continue this regimen in combination with protocol therapy. For the purposes of this study disease progression while receiving hormonal therapy will be defined as: Radiographic evidence of progressive disease according to RECIST criteria, Progression of disease by physical exam in patients with skin involvement. Continued in # 9
- Continuation from # 8: 25% increase in tumor marker as measured on two evaluations no less than 72 hours apart.
- Patients must have and ECOG performance status of </= 2.
- Patients must not require concurrent radiation or chemotherapy while receiving protocol therapy.
- Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics as prophylaxis is allowed.
- Patients must have a baseline ECG with QTc within the normal range within 28 days prior to registration.
- Patients must be informed of the investigational nature of the study and must sign and give written informed consent.
- Patients may have received previous radiation but must have completed radiation at least 2 weeks (8 weeks for radiation to the brain) prior to registration. Patients with irradiated tumor as the only site of evaluable disease will not be eligible for protocol therapy unless there is documented disease progression within the previously radiated site.
- Patients must have recovered to grade </= 1 from all acute toxicity of previous radiation or hormonal therapy.
- Adequate hematologic and hepatic function: Granulocyte count >/= 1,500/mcL, Platelet count >/= 100,000/mcL, Bilirubin </= 1.5 x ULN, AST and/or ALT </= 2 x ULN, Alkaline phosphatase (liver component, if fractionated) </= 2 x ULN, Serum Na, K+, Mg2+, Phosphate and Ca2+>/= Lower Limit of Normal (LLN) [subjects with low electrolyte levels must be repleted to normal for protocol entry]
- Patients must not receive any concurrent bisphosphonate therapy other than that prescribed by the study.
- Sexually active patients with reproductive potential must agree to use an effective method of birth control during the course of the study and for no less than 4 weeks after discontinuing study drug. Contraceptives must be used in a manner such that risk of failure is minimized. Oral contraceptives should be avoided in women with estrogen or progesterone receptor positive breast cancer.
- Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
- All WOCBP MUST have a negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.
- Patients with disease progression while receiving previous therapy in combination with bisphosphonates (including zoledronic acid) will be considered eligible for protocol participation.
Who cannot join
- Any malignancy (other than breast cancer) that required radiotherapy or systemic treatment within the past 5 years.
- Concurrent medical condition which may increase the risk of toxicity, including: Pleural or pericardial effusion of any grade, clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease)
- Cardiac Symptoms, including the following: Uncontrolled angina, congestive heart failure or MI within (6 months), diagnosed congenital long QT syndrome, any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes), prolonged QTc interval on pre-entry electrocardiogram (> normal range), subjects with hypokalemia or hypomagnesemia if it cannot be corrected
- History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders (e.g., von Willebrand's disease), diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies), ongoing or recent (</= 3 months) significant gastrointestinal bleeding
- Concomitant Medications, consider the following prohibitions (Drugs must be discontinued for 7 days prior to starting protocol therapy):
- Women and men of child bearing potential: who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or women of childbearing potential (CBP) who have a positive pregnancy test at baseline, or women who are pregnant or breastfeeding
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- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
- Untreated or uncontrolled brain metastasis
- Patient inability to take or absorb oral medications
- Current active dental problems including: ongoing infection of the teeth or jawbone (maxilla or mandibula); current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw
- Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants)
- Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone)
- Known hypersensitivity to zoledronic acid or aspirin
- Corrected serum calcium < 8.0 mg/dL (2.0 mmol/L) or >/= 12.0 mg/dL (3.0 mmol/L) at Visit 1. The formula to be used is: Corrected serum calcium (mg/dL) = Patient's serum calcium (mg/dL) + [0.8 x Midrange Albumin (g/dL) - Patient's Albumin (g/dL)]. 4.0g/dL to be used for the Midrange Albumin
- Serum creatinine greater than or equal to 1.5 times the institutional upper limits of normal or a creatinine clearance of <40 ml/min when calculated by the Cockcroft and Gault formula (see protocol text for formula)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Chicago
Chicago, Illinois, 60637
Duke University
Durham, North Carolina, 27708
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I/II Study of Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis
The goal of this clinical research study is to find the highest tolerable dose of dasatinib and Zometa (zoledronic acid) that can be given in combination for the treatment of breast cancer that has spread to the bone. The safety and effectiveness of this combination will also be studied.
Read the detailed description
The Study Drugs:
Zoledronic acid is designed to strengthen the bone and prevent fractures or breaks in the bone. Dasatinib is designed to block (stop) cells responsible for the breakdown of bone.
Study Groups:
If you are found to be eligible to take part in this study, you will be enrolled in a group of at least 3 participants to begin receiving zoledronic acid and dasatinib. The dose of dasatinib you receive will depend on when you enrolled in this study. All participants will receive the same amount of zoledronic acid. The first group of participants will be treated with the lowest dose of dasatinib given in combination with zoledronic acid.
Once the highest tolerable dose level is found, up to 25 additional participants will be enrolled at that dose level. This is called the Phase II portion of the study.
Drug Administration:
You will receive zoledronic acid through a needle in your vein on Day 1 over 15 minutes. You will take dasatinib by mouth daily for 28 days. Dasatinib should be taken on an empty stomach or after a light meal. Every 28 days is called a study "cycle."
Study Visits for Participants in the Phase I Portion:
On Day 1 of Cycle 1, you will have the following tests and procedures performed.
- You will have a physical exam, including measurement of your vital signs.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 8 of Cycle 1, you will have the following tests and procedures performed.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 15 of Cycle 1, you will have the following tests and procedures performed.
- You will have a physical exam.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 21 of Cycle 1, you will have the following tests and procedures performed.
- Your vital signs will be measured.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 1 of Cycle 2, you will have an ECG.
On Day 1 of all other cycles, you will have the following tests and procedures performed.
- You will have a physical exam.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have MRIs, CT scans, and/or x-rays to check the status of the disease.
On Days 1 and 28 of Cycle 1 and then every 3rd month, urine will be collected over 24 hours to check for markers of bone loss.
After Cycles 3, 6, 9 and so on, you will have CT scans, MRIs, and/or x-rays to check the status of the disease
At all study visits, you will be asked about any drugs you may be taking and any side effects you may be experiencing.
Study Visits for Participants in the Phase II Portion:
On Day 1 of all cycles, you will have the following tests and procedures performed.
- You will have a physical exam, including measurement of your vital signs.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
On Days 1 and 28 of Cycle 1 and then every 3rd month, urine will be collected to check for markers of bone loss.
After Cycles 2, 4, 6 and so on, you will have CT scans, MRIs, and/or x-rays to check the status of the disease.
At all study visits, you will be asked about any drugs you may be taking and any side effects you may be experiencing.
Length of Study:
You may remain on study for as long as you are benefitting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
Once you go off-study, you will have an end-of-study visit.
- Your vital signs will be measured.
- Blood (about 1-2 teaspoons) and urine will be collected for routine tests.
- You will have MRIs, CT scans, and/or x-rays to check the status of the disease.
This is an investigational study. Zoledronic acid is FDA approved and commercially available for the treatment of breast cancer. Dasatinib is not FDA approved or commercially available for the treatment of breast cancer. It has been authorized for use in research only. Up to 28 patients will take part in this multicenter study. Up to 12 will be enrolled at MD Anderson.
- Conditions
- Breast Cancer, Bone Metastases
- Being tested
- Dasatinib, Zoledronic Acid
- Keywords
- Breast Cancer, Bone Metastases, Breast Cancer with Bone Metastases, Breast Cancer with Metastases to Bone, Dasatinib, Zometa, Zoledronic Acid, Zoledronate, BMS-345825, Sprycel®
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called BMS-345825, Sprycel®
Phase I: First Cohort = 100 mg PO Daily x 28 days; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort.
Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I.
Zoledronic AcidDrug
Also called Zoledronate, Zometa®
Phase I: First Cohort = 4 mg IV Over 15 min. every 4 Weeks; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort.
Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I.
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib + Zoledronic Acid | Experimental | Dasatinib Phase I: First Cohort = 100 mg PO Daily x 28 days; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort.
Zoledronic Acid Phase I: First Cohort = 4 mg IV Over 15 min. every 4 Weeks; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort. Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I. Receives: Drug: Dasatinib; Drug: Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response in Bone From Time of Initiation of Therapy to > 6 Months
Objective response rate is defined as the clinical benefit rate (complete and partial response) + stable disease > 6 months in bone.
Measured: 6 months
Phase I - Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) for Dasatinib in Combination With Zoledronic Acid
To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for dasatinib in combination with zoledronic acid.
Measured: day 1 (+/- 48 hours) prior to therapy during cycle 2 and all subsequent cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study start1 Nov 2007
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Stacy Moulder, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566618
- Sponsor's protocol ID
- 2006-0900
- Other IDs
- NCI-2015-01920
- Status last verified
- Feb 2022
- First submitted
- 29 Nov 2007
- Last updated
- 25 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chen F, Zhao B, Tian Y, Liu Q, Zhang B. Metabolic reprogramming on breast cancer stem Cells: Proliferation and self-renewal, epithelial-mesenchymal transition (EMT), and drug resistance. Biochem Biophys Res Commun. 2025 Aug 8;774:152079. doi: 10.1016/j.bbrc.2025.152079. Epub 2025 May 23.
PubMed 40446745
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis
- ClinicalTrials.gov ID
- NCT00566618
- Acronym / sponsor ID
- 2006-0900
- Conditions
- Breast Cancer, Bone Metastases
- Keywords
- Breast Cancer, Bone Metastases, Breast Cancer with Bone Metastases, Breast Cancer with Metastases to Bone, Dasatinib, Zometa, Zoledronic Acid, Zoledronate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 1 Nov 2007 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 3 Dec 2007 (estimated)
- Results
- Posted 25 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find the highest tolerable dose of dasatinib and Zometa (zoledronic acid) that can be given in combination for the treatment of breast cancer that has spread to the bone. The safety and effectiveness of this combination will also be studied.
Detailed description
The Study Drugs:
Zoledronic acid is designed to strengthen the bone and prevent fractures or breaks in the bone. Dasatinib is designed to block (stop) cells responsible for the breakdown of bone.
Study Groups:
If you are found to be eligible to take part in this study, you will be enrolled in a group of at least 3 participants to begin receiving zoledronic acid and dasatinib. The dose of dasatinib you receive will depend on when you enrolled in this study. All participants will receive the same amount of zoledronic acid. The first group of participants will be treated with the lowest dose of dasatinib given in combination with zoledronic acid.
Once the highest tolerable dose level is found, up to 25 additional participants will be enrolled at that dose level. This is called the Phase II portion of the study.
Drug Administration:
You will receive zoledronic acid through a needle in your vein on Day 1 over 15 minutes. You will take dasatinib by mouth daily for 28 days. Dasatinib should be taken on an empty stomach or after a light meal. Every 28 days is called a study "cycle."
Study Visits for Participants in the Phase I Portion:
On Day 1 of Cycle 1, you will have the following tests and procedures performed.
- You will have a physical exam, including measurement of your vital signs.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 8 of Cycle 1, you will have the following tests and procedures performed.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 15 of Cycle 1, you will have the following tests and procedures performed.
- You will have a physical exam.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 21 of Cycle 1, you will have the following tests and procedures performed.
- Your vital signs will be measured.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 1 of Cycle 2, you will have an ECG.
On Day 1 of all other cycles, you will have the following tests and procedures performed.
- You will have a physical exam.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have MRIs, CT scans, and/or x-rays to check the status of the disease.
On Days 1 and 28 of Cycle 1 and then every 3rd month, urine will be collected over 24 hours to check for markers of bone loss.
After Cycles 3, 6, 9 and so on, you will have CT scans, MRIs, and/or x-rays to check the status of the disease
At all study visits, you will be asked about any drugs you may be taking and any side effects you may be experiencing.
Study Visits for Participants in the Phase II Portion:
On Day 1 of all cycles, you will have the following tests and procedures performed.
- You will have a physical exam, including measurement of your vital signs.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
On Days 1 and 28 of Cycle 1 and then every 3rd month, urine will be collected to check for markers of bone loss.
After Cycles 2, 4, 6 and so on, you will have CT scans, MRIs, and/or x-rays to check the status of the disease.
At all study visits, you will be asked about any drugs you may be taking and any side effects you may be experiencing.
Length of Study:
You may remain on study for as long as you are benefitting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
Once you go off-study, you will have an end-of-study visit.
- Your vital signs will be measured.
- Blood (about 1-2 teaspoons) and urine will be collected for routine tests.
- You will have MRIs, CT scans, and/or x-rays to check the status of the disease.
This is an investigational study. Zoledronic acid is FDA approved and commercially available for the treatment of breast cancer. Dasatinib is not FDA approved or commercially available for the treatment of breast cancer. It has been authorized for use in research only. Up to 28 patients will take part in this multicenter study. Up to 12 will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib + Zoledronic Acid | Experimental | Drug: Dasatinib, Drug: Zoledronic AcidDasatinib Phase I: First Cohort = 100 mg PO Daily x 28 days; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort. Zoledronic Acid Phase I: First Cohort = 4 mg IV Over 15 min. every 4 Weeks; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort. Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients must have a pathologically confirmed diagnosis of invasive carcinoma of the breast.
- Patients must carry a diagnosis of metastatic breast cancer with predominant bone involvement. For the purposes of this study, predominant bone involvement will be defined as radiographically detected bone metastasis in the presence or absence of other sites of metastatic breast cancer (i.e. visceral involvement). If visceral involvement is present, patients must be asymptomatic and have no tumors in visceral organs that measure >3cm in size.
- Patients must agree to serial urine collections for measurement of Ntx.
- Age >/= 18 years.
- Patients must be able to swallow oral medications. Dasatinib must be taken whole and cannot be crushed.
Key exclusion criteria (15 listed)
- Any malignancy (other than breast cancer) that required radiotherapy or systemic treatment within the past 5 years.
- Concurrent medical condition which may increase the risk of toxicity, including: Pleural or pericardial effusion of any grade, clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease)
- Cardiac Symptoms, including the following: Uncontrolled angina, congestive heart failure or MI within (6 months), diagnosed congenital long QT syndrome, any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes), prolonged QTc interval on pre-entry electrocardiogram (> normal range), subjects with hypokalemia or hypomagnesemia if it cannot be corrected
- History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders (e.g., von Willebrand's disease), diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies), ongoing or recent (</= 3 months) significant gastrointestinal bleeding
- Concomitant Medications, consider the following prohibitions (Drugs must be discontinued for 7 days prior to starting protocol therapy):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAlso: BMS-345825, Sprycel®Phase I: First Cohort = 100 mg PO Daily x 28 days; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort. Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I. | Drug | Dasatinib + Zoledronic Acid |
| Zoledronic AcidAlso: Zoledronate, Zometa®Phase I: First Cohort = 4 mg IV Over 15 min. every 4 Weeks; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort. Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I. | Drug | Dasatinib + Zoledronic Acid |
Primary outcome
Objective Response in Bone From Time of Initiation of Therapy to > 6 Months
Time frame: 6 months
Objective response rate is defined as the clinical benefit rate (complete and partial response) + stable disease > 6 months in bone.
Phase I - Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) for Dasatinib in Combination With Zoledronic Acid
Time frame: day 1 (+/- 48 hours) prior to therapy during cycle 2 and all subsequent cycles
To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for dasatinib in combination with zoledronic acid.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40446745Chen F, Zhao B, Tian Y, Liu Q, Zhang B. Metabolic reprogramming on breast cancer stem Cells: Proliferation and self-renewal, epithelial-mesenchymal transition (EMT), and drug resistance. Biochem Biophys Res Commun. 2025 Aug 8;774:152079. doi: 10.1016/j.bbrc.2025.152079. Epub 2025 May 23.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy Moulder, MD principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dasatinib and Zoledronic Acid in people with Breast Cancer and Bone Metastases, run by M.D. Anderson Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response in Bone From Time of Initiation of Therapy to > 6 Months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00566618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.