Breast CancerPhase 2NCT01471106
Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer
A Phase 2 study testing Dasatinib in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this clinical research study is to learn if dasatinib can help prevent breast cancer from developing in the unaffected breast. Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells. This is an investigational study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jan 2014to 30 May 2024
- Phase
- Phase 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of ER negative breast carcinoma (defined as less than 10%), stage I, II, or III
- Completed all adjuvant therapy including (if indicated) endocrine, trastuzumab, radiation therapy
- At least 18 years of age.
- Female: A female is eligible to enter and participate in the study if she is of: a. Non-childbearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation, hysterectomy alone, hysterectomy and bilateral salpingo-oophorectomy, bilateral salpingo-oophorectomy alone or women who are post-menopausal); or b. Childbearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility. This category includes women with oligomenorrhoea (severe), women who are perimenopausal, and young women who have begun to menstruate), has a negative serum pregnancy test at screening, and agrees to one of the following where considered acceptable to the local IRB/IEC: • Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm).
- (Continued from above) • Abstinence from sexual intercourse from 2 weeks prior to administration of the investigational product, throughout the active study treatment period. • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject. • Any intrauterine device (IUD). • Barrier methods including diaphragm or condom with a spermicide.
- Able to swallow and retain oral medication.
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- ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2.
- Provided written informed consent.
- Adequate bone marrow function: Hemoglobin >/= 9 gm/dL. • Absolute granulocyte count >/= 1,500/mm^3 (1.5 x 10^9/L). • Platelets >/= 75,000/mm^3 (100 x 10^9/L).
- Serum creatinine < 1.4 mg/dL or calculated creatinine clearance (CrCl) >/= 30 mL/min
- Total bilirubin </= 1.5 times the upper limit of the reference range
- Aspartate and alanine transaminase (AST or ALT) </= 2 times the upper limit of the reference range.
- Patients must have a baseline ECG with QTcF within the normal range within 28 days prior to registration.
- Normal mammogram of unaffected breast within 12 months prior to study entry.
Who cannot join
- Unwillingness to undergo RPFNA.
- Contraindication to RPFNA including breast implant(s), bilateral radiation, anticoagulation (excluding those on 81mg aspirin).
- Concurrent medical condition that would increase drug toxicity: Pleural or pericardial effusion, coagulation or platelet function disorder, ongoing or recent (less than 3 months gastrointestinal bleeding)
- Uncontrolled angina, congestive heart failure, MI (within last 6 months), congenital long QT syndrome, history of clinically significant ventricular arrhythmia, prolonged QTcF interval on pre-entry EKG (greater than normal range)
- Hypokalemia or hypomagnesemia if it cannot be corrected
- Is a pregnant or lactating female.
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- Has evidence of recurrent or metastatic (Stage IV) breast cancer.
- Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
- Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to dasatinib
- Has received treatment with any investigational drug in the previous 4 weeks.
- Has received chemotherapy, immunotherapy, biologic therapy or endocrine therapy within the past 12 weeks.
- Is currently receiving oral steroid treatment (inhaled steroids are permitted)
- Oral estrogen, progesterone, testosterone therapy within last 3 months.
- Concomitant Medications: Drugs that are considered category D (Consider therapy modification) and X (Avoid combination) using the Lexicomp database are prohibited. Concomitant drugs that fall into categories A (No known interaction), B (no action needed) and C (monitor therapy) are allowed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University
Durham, North Carolina, 27708
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to learn if dasatinib can help prevent breast cancer from developing in the unaffected breast.
Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells.
This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of leukemia. Its use in breast cancer patients in investigational.
Up to 66 patients will take part in this multicenter study. Up to 60 will be enrolled at MD Anderson.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 3 study groups:
- If you are in Group 1, you will take dasatinib 40mg once a day by mouth with water.
- If you are in Group 2, you will take dasatinib 80mg once a day by mouth with water.
- If you are in Group 3, you will not receive dasatinib.
You will be given a study drug diary to complete. In the diary, you will record when you take the study drug.
Study Visits:
At Month 1:
- You will be called by a nurse and asked about any drugs you are taking and side effects you may be having.
- You will be asked about any drugs you may be taking and side effects you may be having.
- Your drug diary will be reviewed.
At Month 2 you will be called by a nurse and asked about any drugs you are taking and side effects you may be having. You will also be asked to review your drug diary. This call will take about 20 minutes
At Month 3 (or if you leave the study early):
- You will have a fine needle aspirate (FNA) of the breast for biomarker testing. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.
- Blood (about 2-3 tablespoons) will be drawn for biomarker testing.
- You will be asked about any drugs you may be taking and side effects you may be having.
- Your drug diary will be reviewed.
Length of Study:
You may remain on study for up to 3 months. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
- Conditions
- Breast Cancer
- Being tested
- Dasatinib
- Keywords
- Breast Cancer, Estrogen Receptor Negative Breast Cancer, Biomarker studies, Ki-67, Dasatinib, BMS-354825, 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-354825, Sprycel
Group 1: 40 mg by mouth once a day.
Group 2: 80 mg by mouth once a day.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dasatinib 40 mg | Experimental | Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. Receives: Drug: Dasatinib |
| Group 3: No Dasatinib | No intervention | No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. |
| Group 2: Dasatinib 80 mg | Experimental | Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ki-67 in Breast Tissue of High-Risk Women
Change in Ki-67 measured in baseline and month 3 using contralateral breast Fine Needle Aspiration (FNA) samples. Samples evaluated by immunohistochemistry (IHC). Baseline and follow up Ki-67 values presented in percentage (%) of cell positive, change reflects difference in percentage. Ki-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett's multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control.
Measured: up to 3 months
Secondary outcomes (3)
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Evaluation of serum utilizing ELISA kits for IGFBP1
Measured: up to 3 months
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Evaluation of serum utilizing ELISA kits for IGF1
Measured: up to 3 months
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Evaluation of serum utilizing ELISA kits for IGFBP3
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study start21 Jan 2014
- Primary completion31 Jan 2024
- Study completion30 May 2024
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Banu Arun, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471106
- Sponsor's protocol ID
- 2010-0794
- Other IDs
- NCI-2012-00037, KG09 1020
- Status last verified
- Jun 2024
- First submitted
- 9 Nov 2011
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01471106
- Acronym / sponsor ID
- 2010-0794
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Estrogen Receptor Negative Breast Cancer, Biomarker studies, Ki-67, Dasatinib, BMS-354825, Sprycel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Bristol-Myers Squibb
- Study start
- 21 Jan 2014 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Posted 10 Jul 2024
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 learn if dasatinib can help prevent breast cancer from developing in the unaffected breast.
Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells.
This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of leukemia. Its use in breast cancer patients in investigational.
Up to 66 patients will take part in this multicenter study. Up to 60 will be enrolled at MD Anderson.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 3 study groups:
- If you are in Group 1, you will take dasatinib 40mg once a day by mouth with water.
- If you are in Group 2, you will take dasatinib 80mg once a day by mouth with water.
- If you are in Group 3, you will not receive dasatinib.
You will be given a study drug diary to complete. In the diary, you will record when you take the study drug.
Study Visits:
At Month 1:
- You will be called by a nurse and asked about any drugs you are taking and side effects you may be having.
- You will be asked about any drugs you may be taking and side effects you may be having.
- Your drug diary will be reviewed.
At Month 2 you will be called by a nurse and asked about any drugs you are taking and side effects you may be having. You will also be asked to review your drug diary. This call will take about 20 minutes
At Month 3 (or if you leave the study early):
- You will have a fine needle aspirate (FNA) of the breast for biomarker testing. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.
- Blood (about 2-3 tablespoons) will be drawn for biomarker testing.
- You will be asked about any drugs you may be taking and side effects you may be having.
- Your drug diary will be reviewed.
Length of Study:
You may remain on study for up to 3 months. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Dasatinib 40 mg | Experimental | Drug: DasatinibDasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. |
| Group 3: No Dasatinib | No intervention | –No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. |
| Group 2: Dasatinib 80 mg | Experimental | Drug: DasatinibDasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histological confirmation of ER negative breast carcinoma (defined as less than 10%), stage I, II, or III
- Completed all adjuvant therapy including (if indicated) endocrine, trastuzumab, radiation therapy
- At least 18 years of age.
- Female: A female is eligible to enter and participate in the study if she is of: a. Non-childbearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation, hysterectomy alone, hysterectomy and bilateral salpingo-oophorectomy, bilateral salpingo-oophorectomy alone or women who are post-menopausal); or b. Childbearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility. This category includes women with oligomenorrhoea (severe), women who are perimenopausal, and young women who have begun to menstruate), has a negative serum pregnancy test at screening, and agrees to one of the following where considered acceptable to the local IRB/IEC: • Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm).
- (Continued from above) • Abstinence from sexual intercourse from 2 weeks prior to administration of the investigational product, throughout the active study treatment period. • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject. • Any intrauterine device (IUD). • Barrier methods including diaphragm or condom with a spermicide.
Key exclusion criteria (14 listed)
- Unwillingness to undergo RPFNA.
- Contraindication to RPFNA including breast implant(s), bilateral radiation, anticoagulation (excluding those on 81mg aspirin).
- Concurrent medical condition that would increase drug toxicity: Pleural or pericardial effusion, coagulation or platelet function disorder, ongoing or recent (less than 3 months gastrointestinal bleeding)
- Uncontrolled angina, congestive heart failure, MI (within last 6 months), congenital long QT syndrome, history of clinically significant ventricular arrhythmia, prolonged QTcF interval on pre-entry EKG (greater than normal range)
- Hypokalemia or hypomagnesemia if it cannot be corrected
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-354825, SprycelGroup 1: 40 mg by mouth once a day. Group 2: 80 mg by mouth once a day. | Drug | Group 1: Dasatinib 40 mg, Group 2: Dasatinib 80 mg |
Primary outcome
Change in Ki-67 in Breast Tissue of High-Risk Women
Time frame: up to 3 months
Change in Ki-67 measured in baseline and month 3 using contralateral breast Fine Needle Aspiration (FNA) samples. Samples evaluated by immunohistochemistry (IHC). Baseline and follow up Ki-67 values presented in percentage (%) of cell positive, change reflects difference in percentage. Ki-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett's multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control.
3 secondary outcomes
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Time frame: up to 3 months
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Time frame: up to 3 months
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Time frame: up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Banu Arun, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 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 14 inclusion and 14 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 phase mean?
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 10 Jul 2024). 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?
Change in Ki-67 in Breast Tissue of High-Risk Women (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2024.