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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


Phase 2
18 Years
80 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


Inclusion Criteria:



- 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+)

1. Clinical stage II or stage III invasive mammary carcinoma, confirmed by
histological analysis, as defined in the study protocol.

2. Subject's age must be greater than or equal to 18 years.

3. ECOG Performance Status of 0-1.

4. 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).

5. No history of prior chemotherapy for primary breast cancer.

6. 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.

7. 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.

8. 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.

9. Ability to swallow and retain oral medications (dasatinib must be swallowed
whole).

10. Subject must not be taking any prohibited medications, as defined in Section 6.5
of the study protocol.

11. 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.

12. 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.

Exclusion Criteria:

1. Locally recurrent breast cancer.

2. History of prior chemotherapy for breast cancer.

3. History of malignancy requiring radiotherapy or systemic treatment within the past 5
years.

4. 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.

5. Subjects taking any prohibited medications will be excluded from study, as defined in
Section 6.5 of the study protocol.

6. 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.

7. Active or uncontrolled infection.

8. Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Efficacy

Outcome Description:

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.

Outcome Time Frame:

Assessment at pre-surgery or 3 to 4 weeks of treatment.

Safety Issue:

No

Principal Investigator

Mothaffar Rimawi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

H 21592

NCT ID:

NCT00817531

Start Date:

December 2008

Completion Date:

February 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Baylor College of Medicine, Lester and Sue Smith Breast CenterHouston, Texas  77030