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Dasatinib for Breast Cancer

Q: Have other investigations been conducted with Dasatinib?

<p>As of the present, 64 trials studying <a href="https://www.withpower.com/clinical-trials/dasatinib">Dasatinib</a>'s efficacy are being conducted, with 9 in Phase 3. <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> is a major centre for research on this medication; however there are 4258 sites running tests globally.</p>

Q: Has the Food and Drug Administration given its seal of approval to Dasatinib?

<p>Our team has judged <a href="https://www.withpower.com/clinical-trials/dasatinib">Dasatinib</a>'s safety as a 2 based on the fact that this is still in Phase 2 testing, with existing data indicating some levels of security but insufficient evidence to support efficacy.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Ki-67 in Breast Tissue of High-Risk Women

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046

26%

Febrile neutropenia

17%

Sepsis

Mucositis oral

Upper gastrointestinal hemorrhage

Intracranial hemorrhage

Hypotension

Hypertension

Enterocolitis

Lower gastrointestinal hemorrhage

Delirium

Oropharyngeal pain

Gastric hemorrhage

Abdominal pain

Diarrhea

Fungemia

Typhlitis

Myocardial infarction

Fibrinogen decreased

Endophthalmitis

Multi-organ failure

Kidney infection

Peripheral motor neuropathy

Hypoxia

Sinus bradycardia

Edema limbs

Small intestinal obstruction

Atrial fibrillation

Aspiration

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,755 Total Patients Enrolled

147 Trials studying Breast Cancer

63,260 Patients Enrolled for Breast Cancer

Susan G. Komen Breast Cancer FoundationOTHER

65 Previous Clinical Trials

217,162 Total Patients Enrolled

40 Trials studying Breast Cancer

215,046 Patients Enrolled for Breast Cancer

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,488 Total Patients Enrolled

50 Trials studying Breast Cancer

8,239 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for people to participate in this clinical examination?

"According to clinicaltrials.gov, this medical experiment is no longer actively recruiting; its original post date was January 21st 2014 and the most recent edit occurred on May 4th 2022. Despite this, there are currently over two-thousand six hundred sixty three other trials that seek volunteers."

Answered by AI

What is the aggregate enrollment rate for this research endeavor?

"This trial is not open for recruitment presently. It was initially posted on the 21st of January 2014, and its most recent amendment was made on May 4th 2022. Alternatively, if you are searching for other studies; 2599 trials specifically targeting breast cancer and 64 Dasatinib clinical experiences have vacancies available."

Answered by AI

Have other investigations been conducted with Dasatinib?

"As of the present, 64 trials studying Dasatinib's efficacy are being conducted, with 9 in Phase 3. New york is a major centre for research on this medication; however there are 4258 sites running tests globally."

Answered by AI

Has the Food and Drug Administration given its seal of approval to Dasatinib?

"Our team has judged Dasatinib's safety as a 2 based on the fact that this is still in Phase 2 testing, with existing data indicating some levels of security but insufficient evidence to support efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer

2014. "Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01471106.

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