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Dasatinib for Breast Cancer

Phase 2
Waitlist Available
Led By Banu Arun, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Histological confirmation of ER negative breast carcinoma (defined as less than 10%), stage I, II, or III
Must not have
Unwillingness to undergo RPFNA
Contraindication to RPFNA including breast implant(s), bilateral radiation, anticoagulation (excluding those on 81mg aspirin)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is for women who have been diagnosed with stage 0, I, or II breast cancer in one breast and have no evidence of cancer in the other breast.

Who is the study for?
This trial is for women with estrogen receptor negative breast cancer who have completed all adjuvant therapy. They must be at least 18, able to swallow pills, and have normal organ function tests. Women of childbearing potential must follow specific contraception guidelines. Exclusions include pregnancy, recent other treatments or investigational drugs, certain medical conditions like heart issues or bleeding disorders.
What is being tested?
The study is testing dasatinib's effectiveness in preventing the development of breast cancer in the unaffected breast. Dasatinib targets proteins that cause tumor growth and is approved for leukemia but not yet for breast cancer. This phase II trial involves up to 66 participants across multiple centers.
What are the potential side effects?
Potential side effects of dasatinib may include fluid retention (like pleural effusion), gastrointestinal disturbances, blood cell count changes leading to increased infection risk or bleeding problems, muscle cramps, skin rashes, headaches and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My breast cancer is ER negative and is in stage I, II, or III.
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I can swallow and keep down pills.
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I can take care of myself and am up and about more than half of my waking hours.
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My blood tests show normal levels of hemoglobin, granulocytes, and platelets.
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My kidney function is within the required range.
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I have finished all my additional cancer treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not willing to undergo a fine needle aspiration biopsy.
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I cannot have RPFNA due to breast implants, radiation, or being on certain blood thinners.
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I do not have any conditions that could worsen with medication, like bleeding or effusions.
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I do not have uncontrolled heart issues or a recent heart attack.
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I have had cancer treatment like chemotherapy in the last 3 months.
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I am currently taking oral steroids, but inhaled steroids are okay.
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My breast cancer has returned or spread to other parts of my body.
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I am not taking any medications that are strongly advised against for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Ki-67 in Breast Tissue of High-Risk Women
Secondary study objectives
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046
26%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Hypotension
4%
Hypertension
4%
Intracranial hemorrhage
4%
Enterocolitis
2%
Lower gastrointestinal hemorrhage
2%
Typhlitis
2%
Peripheral motor neuropathy
2%
Small intestinal obstruction
2%
Fungemia
2%
Oropharyngeal pain
2%
Multi-organ failure
2%
Abdominal pain
2%
Hypoxia
2%
Edema limbs
2%
Kidney infection
2%
Sinus bradycardia
2%
Gastric hemorrhage
2%
Myocardial infarction
2%
Diarrhea
2%
Fibrinogen decreased
2%
Aspiration
2%
Atrial fibrillation
2%
Delirium
2%
Endophthalmitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group 2: Dasatinib 80 mgExperimental Treatment1 Intervention
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.
Group II: Group 1: Dasatinib 40 mgExperimental Treatment1 Intervention
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.
Group III: Group 3: No DasatinibActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
2012
Completed Phase 3
~2320

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,053 Previous Clinical Trials
1,798,693 Total Patients Enrolled
147 Trials studying Breast Cancer
63,216 Patients Enrolled for Breast Cancer
Susan G. Komen Breast Cancer FoundationOTHER
67 Previous Clinical Trials
220,212 Total Patients Enrolled
40 Trials studying Breast Cancer
215,049 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,680 Previous Clinical Trials
4,124,877 Total Patients Enrolled
50 Trials studying Breast Cancer
8,221 Patients Enrolled for Breast Cancer

Media Library

Dasatinib Clinical Trial Eligibility Overview. Trial Name: NCT01471106 — Phase 2
Breast Cancer Research Study Groups: Group 1: Dasatinib 40 mg, Group 3: No Dasatinib, Group 2: Dasatinib 80 mg
Breast Cancer Clinical Trial 2023: Dasatinib Highlights & Side Effects. Trial Name: NCT01471106 — Phase 2
Dasatinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT01471106 — Phase 2
~2 spots leftby Oct 2025
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