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A Phase II Study of AZD0530 in Hormone Receptor-Negative, Metastatic or Unresectable, Locally Advanced Breast Cancer

Phase 2
18 Years
Not Enrolling
Estrogen Receptor-negative Breast Cancer, Male Breast Cancer, Progesterone Receptor-negative Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

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Trial Information

A Phase II Study of AZD0530 in Hormone Receptor-Negative, Metastatic or Unresectable, Locally Advanced Breast Cancer


I. To estimate the disease control rate of AZD0530 (saracatinib) in patients with metastatic
breast cancer.


I. To estimate the efficacy of AZD0530 in terms of overall response rate (complete and
partial response) and progression free survival.

II. To describe the toxicity profile of AZD0530 in this patient population. III. To
prospectively explore changes in circulating tumor cells from pre-treatment levels in
patients receiving AZD0530.


Patients receive saracatinib orally (PO) on days 1-28. Treatment repeats every 28 days in
the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Inclusion Criteria:

- Histologically or cytologically confirmed carcinoma of the breast

- Unresectable disease

- Locally advanced or metastatic (American Joint Committee on Cancer [AJCC] stage
IV) disease

- Estrogen receptor-negative and progesterone receptor-negative breast cancer defined
as < 10% expression by immunohistochemistry (IHC)

- Measurable disease, defined (per Response Evaluation Criteria in Solid Tumors
[RECIST]) as ≥ 1 unidimensionally measurable lesion ≥ 20mm by conventional techniques
or ≥ 10 mm by spiral computed tomography (CT) scan

- Measurable target lesions must not be in a previously irradiated field

- Patients with locally advanced, unresectable disease must have progression of disease
following no more than one first-line chemotherapy regimen

- Patients with evidence of recurrent disease during or within 6 months after adjuvant
chemotherapy will be considered to have failed one line of chemotherapy for
metastatic disease

- Human epidermal growth factor receptor 2 (HER2)-positive patients, defined as
immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH)
amplification > 2.1, must have received trastuzumab (Herceptin®) in either the
adjuvant or metastatic setting and have had recurrence or progression of disease,

- No known brain metastases

- Male and female patients eligible

- Menopausal status not specified

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 (Karnofsky PS

- Life expectancy > 3 months

- Absolute neutrophil count ≥ 1,500/mcL

- Platelet count ≥ 100,000/mcL

- Hemoglobin > 9 g/dL

- Total bilirubin normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT])
≤ 2.5 x institutional upper limit of normal

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- Urine protein creatinine (UPC) ratio must be ≤ 1.0

- Patients with a UPC ratio > 1.0 must have a 24-hour urine protein < 1,000 mg to
be eligible for study

- Not pregnant or nursing

- Women of child-bearing potential and men must use adequate contraception (e.g.,
hormonal or barrier method of birth control or abstinence) prior to, during, and for
8 weeks after completion of study therapy

- Able to understand and willing to sign a written informed consent document

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to AZD0530

- No QTc interval ≥ 500 msecs

- No condition that impairs the ability to swallow AZD0530 tablets, including the

- Gastrointestinal tract disease resulting in an inability to take oral medication
or a requirement for IV alimentation

- Prior surgical procedures affecting absorption

- Active peptic ulcer disease

- No intercurrent cardiac dysfunction including, but not limited to, any of the

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Uncontrolled cardiac arrhythmia

- History of myocardial infarction within 6 months of treatment

- No uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements

- No severe restrictive or obstructive lung disease according to baseline pulmonary
function studies including any of the following pulmonary function test (PFT)

- Total lung capacity < 60%

- Forced vital capacity < 50%

- Forced expiratory volume in one second (FEV_1) < 50%

- Diffusion capacity of carbon monoxide (DLCO) < 50%

- Resting room air O_2 saturation < 92% or a decline in O_2 saturation > 4% with

- Patients with metastatic disease may have received no more than 1 prior chemotherapy

- No unresolved toxicity ≥ grade 3 from agents received more than 3 weeks earlier

- No chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering study

- No luteinizing hormone-releasing hormone agonists within 4 weeks prior to study entry

- More than 7 days since prior and no concurrent use of specifically prohibited
cytochrome P 450 3A4 (CYP3A4) agents

- No concurrent megestrol acetate, even when prescribed for appetite stimulation

- No other concurrent investigational or commercial agents for the treatment of breast

- No concurrent combination antiretroviral therapy for human immunodeficiency virus
(HIV)-positive patients

- No concurrent megestrol acetate

Type of Study:


Study Design:

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

Outcome Measure:

Disease control rate (DCR)

Outcome Description:

DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon's two-stage optimal design will be used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allows for early termination of the study.

Outcome Time Frame:

After 24 weeks of study therapy

Safety Issue:


Principal Investigator

Clifford Hudis

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2007

Completion Date:

Related Keywords:

  • Estrogen Receptor-negative Breast Cancer
  • Male Breast Cancer
  • Progesterone Receptor-negative Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



Memorial Sloan Kettering Cancer Center New York, New York  10021