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A Phase I/II Trial of Dasatinib in Combination With Trastuzumab and Paclitaxel in the First Line Treatment of Her2-Positive Metastatic Breast Cancer (Mbc) Patients

Phase 1/Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Phase I/II Trial of Dasatinib in Combination With Trastuzumab and Paclitaxel in the First Line Treatment of Her2-Positive Metastatic Breast Cancer (Mbc) Patients

Inclusion Criteria:

- Female with histologically confirmed breast cancer with documented metastasis.

- Patients must have HER-2 overexpression by immunohistochemistry (3+, Herceptest;
DAKO) or a positive fluorescence in situ hybridization for HER2 amplification
evaluated by central laboratory. It is recommended that a formalin-fixed
paraffin embedded (FFPE) tumor tissue block from the metastatic site (or the
primary tumor, if metastatic site not available) required for HER2 testing are

- Patients can have measurable or non measurable disease for the Phase I part. For
the Phase II only patients with measurable disease defined per RECIST 1.1 will
be included.

- Signed Written Informed Consent.

- Patients with Performance Status (ECOG) of 0 or 1.

- Number of previous therapies allowed or previous therapies may have included:

1. Chemotherapy: no prior chemotherapy for MBC is permitted. Patients treated
with adjuvant chemotherapy regimens based on taxanes are allowed to be
included if they are fully recovered of any taxane associated toxicity and
a minimum of 12 months have elapsed from the end of this therapy.

2. Hormonal Therapy: patients may have had prior hormonal therapy. All
hormonal agents must be discontinued at least 3 weeks prior to study entry.

3. Radiation Therapy: patients may have had prior radiation therapy that has
not exceeded 25% of the bone marrow reserve. A minimum of 21 days must have
elapsed between the last dose of radiation and registration into the study.
Patients must have recovered from any acute toxic effects from radiation
prior to registration. Lesions that have been irradiated cannot be included
as sites of measurable disease for the phase II unless clear tumor
progression, according to RECIST criteria, has been documented in these
lesions since the end of radiation therapy.

4. Previous Surgery: previous surgery is permitted provided that wound healing
has occurred.

5. Anti-HER2 Therapies: no prior anti-HER2 therapy for MBC is permitted.
Patients treated with adjuvant anti-HER2 therapies (including but not
limited to trastuzumab and lapatinib) are allowed to be included if a
minimum of 12 months have elapsed from the end of this therapy.

- Adequate Organ Function.

- Ability to take oral medication (dasatinib must be swallowed whole).

- Patient, age 18 years old.

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy.

Exclusion Criteria:

- Women who are pregnant or breastfeeding.

- Patients with known brain metastases.

- No malignancy [other than the one treated in this study] which required radiotherapy
or systemic treatment within the past 5 years.

- Concurrent medical condition which may increase the risk of toxicity, including:
Pleural or pericardial effusion of any grade.

- Cardiac Symptoms; any of the following should be considered for exclusion:

1. Uncontrolled angina, congestive heart failure or MI within (6 months)

2. Patients with intercurrent cardiac dysfunction or LVEF < 50%.

3. Diagnosed congenital long QT syndrome.

4. Any history of clinically significant ventricular arrhythmias (such as
ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).

5. Prolonged QTc interval on pre-entry electrocardiogram (450 msec).

6. Patients with hypokalemia or hypomagnesemia if it cannot be corrected prior to
dasatinib administration.

- History of significant bleeding disorder unrelated to cancer, including:

1. Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).

2. Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor
VIII antibodies).

3. Ongoing or recent (3 months) significant gastrointestinal bleeding.

- Patients with known allergy to any of the study drugs or their components.

- Pre-existent toxicities of severity grade 2 due to previous anti-cancer treatments.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose (MTD) and recommended phase II dose (RPD) of dasatinib in combination with fixed doses of trastuzumab and paclitaxel in HER2-positive MBC patients (Phase I).

Outcome Time Frame:

6-12 months 3,5 years since the beginning of the study

Safety Issue:


Principal Investigator

Alberto OcaƱa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Complejo Hospitalario Universitario de Albacete


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

July 2011

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer
  • HER2+ metastatic breast cancer
  • first line treatment
  • Breast Neoplasms