Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27708
- Duke University
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Group 1: Dasatinib 40 mg
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 1: 40 mg by mouth once a day. Group 2: 80 mg by mouth once a day.
Other Names:
|
|
No Intervention: Group 3: No Dasatinib
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.
|
|
|
Experimental: Group 2: Dasatinib 80 mg
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 1: 40 mg by mouth once a day. Group 2: 80 mg by mouth once a day.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 3 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Time Frame: up to 3 months
|
Evaluation of serum utilizing ELISA kits for IGFBP1
|
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
|
Evaluation of serum utilizing ELISA kits for IGF1
|
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
|
Evaluation of serum utilizing ELISA kits for IGFBP3
|
up to 3 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Banu Arun, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2010-0794
- NCI-2012-00037 (Registry Identifier: NCI CTRP)
- KG09 1020 (Other Identifier: Susan G. Komen Breast Cancer Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
NCT01372579UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer
-
NCT01292083WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
-
NCT07331506RecruitingBreast Cancer Female | Breast Cancer Detection | Breast Cancer Early Stage Breast Cancer (Stage 1-3) | Breast Cancer With Low to Intermediate HER2 Expression | Breast Cancer - Female | Breast Cancer (Early Breast Cancer) | Breast Cancer - Ductal Carcinoma in Situ (DCIS) | Breast Cancer - Infiltrating Ductal Carcinoma
-
NCT00618657CompletedBreast Cancer | HER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast Cancer
-
NCT00407888CompletedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-positive Breast Cancer
-
NCT00986609CompletedBreast Cancer | Stage I Breast Cancer | Inflammatory Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer
-
NCT02566408CompletedCancer Survivor | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer
-
NCT00513695CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer
-
NCT05020860RecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer
-
NCT02580448CompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the Breast
Clinical Trials on Dasatinib
-
NCT01392703CompletedPharmacokinetic Study in Healthy Participants
-
NCT04439305WithdrawnHematopoietic and Lymphoid Cell Neoplasm | Advanced Lymphoma | Advanced Malignant Solid Neoplasm | Refractory Lymphoma | Refractory Malignant Solid Neoplasm | Refractory Plasma Cell Myeloma
-
NCT02059265TerminatedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Cystadenocarcinoma | Endometrial Clear Cell Adenocarcinoma | Recurrent Uterine Corpus Cancer
-
NCT05439408Completed
-
NCT02776878UnknownGastrointestinal Stromal Tumor
-
NCT01887561UnknownMyelogenous Leukemia, Chronic, Chronic Phase
-
NCT00254423CompletedChronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia
-
NCT00064233Completed
-
NCT00568750CompletedGastrointestinal Stromal Tumor