Breast CancerPhase 2NCT00817531
Efficacy Study of Dasatinib in Locally Advanced Triple-Negative Breast Cancer Patients
A Phase 2 study testing Dasatinib in people with Breast Cancer, run by Baylor Breast Care Center at 1 site in United States.
Trial summary
We want to learn if dasatinib will make triple negative breast cancers smaller. We also hope that we can learn more about what makes triple negative breast cancers grow. We believe this information will help us to predict which patients will benefit from taking this drug or other drugs like it. Read more about this study
- Who is it for?
- Ages 18 to 80 years, 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
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Feb 2011
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with triple negative breast cancer (breast cancer is not estrogen receptor positive (ER+), progesterone receptor positive (PgR+) or human epidermal growth factor receptor positive (HER2+)
- Clinical stage II or stage III invasive mammary carcinoma, confirmed by histological analysis, as defined in the study protocol.
- Subject's age must be greater than or equal to 18 years.
- ECOG Performance Status of 0-1.
- Subjects must have measurable* tumor at the primary site. *Measurable disease is defined as follows: Any mass that can be reproducibly measured by physical examination, mammogram, and/or ultrasound and can be accurately measured in at least one dimension (longest diameter to be recorded) as 10 mm (1 cm).
- No history of prior chemotherapy for primary breast cancer.
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- Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer within the past 5 years.
- Women may have been taking tamoxifen or raloxifene as a preventive agent prior to study entry but must have discontinued the drug for at least 21 days prior to study enrollment.
- Adequate organ function, as defined by the following: a) Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN) b) Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN c) Serum sodium, potassium, magnesium, phosphate, and calcium levels greater than or equal to the Lower Limit of Normal (LLN). d) Serum Creatinine < 1.5 time the institutional ULN e) Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0-1, as defined by the NCI CTCAE v3.0.
- Ability to swallow and retain oral medications (dasatinib must be swallowed whole).
- Subject must not be taking any prohibited medications, as defined in Section 6.5 of the study protocol.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (sensitivity < 25 IU/L) within 72 hours prior to beginning study medication.
- WOCBP must agree to utilize an adequate method of contraception throughout treatment, and for at least 4 weeks after stopping study medication. 13. Signed, written informed consent, including a HIPAA form, as per institutional guidelines.
Who cannot join
- Locally recurrent breast cancer.
- History of prior chemotherapy for breast cancer.
- History of malignancy requiring radiotherapy or systemic treatment within the past 5 years.
- Presence of any concurrent medical condition that would increase the risk of toxicity, including the following: •Pleural or pericardial effusion of any grade •Uncontrolled angina •Congestive heart failure •Myocardial infarction within the past 6 months •Diagnosed congenital long QT syndrome •Any history of clinical significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) •Prolonged QTc interval (> 450 ms) on pre-study ECG •Uncorrectable hypokalemia or hypomagnesia •Significant bleeding disorder unrelated to cancer, including: - History of congenital bleeding disorders (e.g. von Willebrand's disease) - Acquired bleeding disorder that has been diagnosed within the past year (e.g. acquired anti-factor VIII antibodies) - Ongoing or recent (less than or equal to 3 months) significant gastrointestinal bleeding.
- Subjects taking any prohibited medications will be excluded from study, as defined in Section 6.5 of the study protocol.
- WOCBP who are pregnant or breastfeeding or who are unwilling to use an acceptable method of contraception for the duration of study therapy and for at least 4 weeks after cessation of study drug.
- Active or uncontrolled infection.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine, Lester and Sue Smith Breast Center
Houston, Texas, 77030
About this study
Official title: A Biologic Efficacy Study of Dasatinib, a Multi-Targeted Tyrosine Kinase, in Locally Advanced Triple-Negative Breast Cancer Patients Developing Effective Therapies for Er-Negative Breast Cancer Using Genomics and Proteomics: Project 3
We want to learn if dasatinib will make triple negative breast cancers smaller. We also hope that we can learn more about what makes triple negative breast cancers grow. We believe this information will help us to predict which patients will benefit from taking this drug or other drugs like it.
This study is a "neoadjuvant study", which means that it is only open to women who have not had any treatment for their breast cancer. Neoadjuvant studies allow the study doctor to look at how the cells in your cancer change after taking the study medication. This will help us to understand whether or not dasatinib is an effective treatment for breast cancer. It will also help us to learn more about triple negative breast cancer and how to treat it.
Read the detailed description
Women who have been recently diagnosed with a type of breast cancer called "triple negative", and have not yet received any type of treatment (surgery, radiation therapy, etc.) for breast cancer are among the patient population this study will seek. "Triple negative" means breast cancer is not estrogen receptor positive (ER+), progesterone receptor positive (PgR+) or human epidermal growth factor receptor positive (HER2+). Some types of breast cancers "overexpress" one or more of these receptors. "Overexpress" means that the cancer cells have too many of these receptors. ER and PgR are hormone receptors that are located on some types of breast cancer cells. When these receptors are present, the hormones estrogen and progesterone are able to tell cancer cells to grow and divide.
This kind of breast cancer does not have an over-production (overexpression) of these three receptors, and that is why we call it "triple-negative" breast cancer.
We are trying to find new and better treatments for women with triple negative breast cancer. We do not know what causes triple negative breast cancers to grow. Other research studies have shown that "triple negative" breast cancers overexpress different types of receptors. These receptors might help the cancer to grow.
We will be testing a drug called dasatinib. Dasatinib is a drug that is made by Bristol-Myers Squibb. It is sold under the name of Sprycel. It was first used to treat patients with leukemia, a type of blood cancer.
Dasatinib interferes with the growth of some cancers. Dasatinib attaches to the cancer cell and slows down or stops the cancer cell from growing. It is approved by the Food and Drug Administration (FDA), but not for the kind of cancer that you have been diagnosed with.
- Conditions
- Breast Cancer
- Being tested
- Dasatinib
- Keywords
- Breast Cancer
- 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 Sprycel
pill form, 100 mg daily
| Study group | Role | What they receive |
|---|---|---|
| All subjects take open label Dasatinib | Experimental | Dasatinib / Sprycel 100 mg Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Efficacy
The clinical response was assessed using RECIST and based on the changes in the longest diameter of the target lesion measured. Complete Response (CR), Disappearance of the target lesion; Partial Response (PR), >=30% decrease in the diameter of target lesion compared to baseline; Progressive disease (PD), >= 20% increase in the diameter of target lession, taking as reference the smallest diameter recorded since the baseline measurement or the appearance of new lesion; Stable disease (SD), neither sufficient shrinkage as PR or sufficient increase as PD.
Measured: Assessment at pre-surgery or 3 to 4 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: terminated due to futility after interim analysis
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Breast Care Center
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Mothaffar Rimawi, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817531
- Sponsor's protocol ID
- H 21592
- Status last verified
- Aug 2012
- First submitted
- 5 Jan 2009
- Last updated
- 31 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biologic Efficacy Study of Dasatinib, a Multi-Targeted Tyrosine Kinase, in Locally Advanced Triple-Negative Breast Cancer Patients Developing Effective Therapies for Er-Negative Breast Cancer Using Genomics and Proteomics: Project 3
- ClinicalTrials.gov ID
- NCT00817531
- Acronym / sponsor ID
- H 21592
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to futility after interim analysis
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Baylor Breast Care CenterUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Dec 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Posted 17 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We want to learn if dasatinib will make triple negative breast cancers smaller. We also hope that we can learn more about what makes triple negative breast cancers grow. We believe this information will help us to predict which patients will benefit from taking this drug or other drugs like it.
This study is a "neoadjuvant study", which means that it is only open to women who have not had any treatment for their breast cancer. Neoadjuvant studies allow the study doctor to look at how the cells in your cancer change after taking the study medication. This will help us to understand whether or not dasatinib is an effective treatment for breast cancer. It will also help us to learn more about triple negative breast cancer and how to treat it.
Detailed description
Women who have been recently diagnosed with a type of breast cancer called "triple negative", and have not yet received any type of treatment (surgery, radiation therapy, etc.) for breast cancer are among the patient population this study will seek. "Triple negative" means breast cancer is not estrogen receptor positive (ER+), progesterone receptor positive (PgR+) or human epidermal growth factor receptor positive (HER2+). Some types of breast cancers "overexpress" one or more of these receptors. "Overexpress" means that the cancer cells have too many of these receptors. ER and PgR are hormone receptors that are located on some types of breast cancer cells. When these receptors are present, the hormones estrogen and progesterone are able to tell cancer cells to grow and divide.
This kind of breast cancer does not have an over-production (overexpression) of these three receptors, and that is why we call it "triple-negative" breast cancer.
We are trying to find new and better treatments for women with triple negative breast cancer. We do not know what causes triple negative breast cancers to grow. Other research studies have shown that "triple negative" breast cancers overexpress different types of receptors. These receptors might help the cancer to grow.
We will be testing a drug called dasatinib. Dasatinib is a drug that is made by Bristol-Myers Squibb. It is sold under the name of Sprycel. It was first used to treat patients with leukemia, a type of blood cancer.
Dasatinib interferes with the growth of some cancers. Dasatinib attaches to the cancer cell and slows down or stops the cancer cell from growing. It is approved by the Food and Drug Administration (FDA), but not for the kind of cancer that you have been diagnosed with.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects take open label Dasatinib | Experimental | Drug: DasatinibDasatinib / Sprycel 100 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Women diagnosed with triple negative breast cancer (breast cancer is not estrogen receptor positive (ER+), progesterone receptor positive (PgR+) or human epidermal growth factor receptor positive (HER2+)
Key exclusion criteria (8 listed)
- Locally recurrent breast cancer.
- History of prior chemotherapy for breast cancer.
- History of malignancy requiring radiotherapy or systemic treatment within the past 5 years.
- Presence of any concurrent medical condition that would increase the risk of toxicity, including the following: •Pleural or pericardial effusion of any grade •Uncontrolled angina •Congestive heart failure •Myocardial infarction within the past 6 months •Diagnosed congenital long QT syndrome •Any history of clinical significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) •Prolonged QTc interval (> 450 ms) on pre-study ECG •Uncorrectable hypokalemia or hypomagnesia •Significant bleeding disorder unrelated to cancer, including: - History of congenital bleeding disorders (e.g. von Willebrand's disease) - Acquired bleeding disorder that has been diagnosed within the past year (e.g. acquired anti-factor VIII antibodies) - Ongoing or recent (less than or equal to 3 months) significant gastrointestinal bleeding.
- Subjects taking any prohibited medications will be excluded from study, as defined in Section 6.5 of the study protocol.
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: Sprycelpill form, 100 mg daily | Drug | All subjects take open label Dasatinib |
Primary outcome
Clinical Efficacy
Time frame: Assessment at pre-surgery or 3 to 4 weeks of treatment.
The clinical response was assessed using RECIST and based on the changes in the longest diameter of the target lesion measured. Complete Response (CR), Disappearance of the target lesion; Partial Response (PR), >=30% decrease in the diameter of target lesion compared to baseline; Progressive disease (PD), >= 20% increase in the diameter of target lession, taking as reference the smallest diameter recorded since the baseline measurement or the appearance of new lesion; Stable disease (SD), neither sufficient shrinkage as PR or sufficient increase as PD.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mothaffar Rimawi, MD principal investigator
Baylor College of Medicine
1 site 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 Baylor Breast Care Center at 1 site 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 13 inclusion and 8 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: stopped early, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 17 Jul 2012). 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?
Clinical Efficacy (time frame: Assessment at pre-surgery or 3 to 4 weeks of treatment.). 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 31 Aug 2012.