Efficacy Study of Dasatinib in Locally Advanced Triple-Negative Breast Cancer Patients

NCT00817531 | Terminated Phase 2 Results DMC

• 1 other identifier: H 21592
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

All subjects take open label Dasatinib

EXPERIMENTAL

Dasatinib / Sprycel 100 mg

Drug: Dasatinib

Interventions

Dasatinib DRUG

pill form, 100 mg daily

Also known as: Sprycel

All subjects take open label Dasatinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Breast Care Center: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

Baylor College of Medicine, Lester and Sue Smith Breast Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

The study was terminated after internal analysis due to treatment futility. It does not meet the required number of responses to continue the study.

Results Point of Contact

• Title: Dr. Mothaffar Rimawi
• Organization: Baylor College of Medicine

rimawi@bcm.edu

713-798-1311

Study Officials

• Mothaffar Rimawi, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: December 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 31, 2012
• Results First Posted: July 17, 2012

Record last verified: 2012-08

Locations

US (1)