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Randomized Phase II Study of Two Doses of Pixantrone in Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Randomized Phase II Study of Two Doses of Pixantrone in Patients With Metastatic Breast Cancer



- To assess the proportion of confirmed tumor responses in patients with HER2-negative
metastatic breast cancer treated with pixantrone dimaleate.


- To describe the distribution of progression-free survival (PFS) times of patients
treated with this drug.

- To assess the 6-month PFS rate in patients treated with this drug.

- To describe the overall survival of patients treated with this drug.

- To assess the adverse event profile of this drug in these patients.

- To evaluate the quality of life and patient-reported symptoms of patients treated with
this drug.

- To evaluate quantitative and qualitative changes of circulating tumor cells after
pixantrone dimaleate therapy. (Correlative study)

- To bank blood and tissue samples for future evaluation of pharmacogenetic and/or
proteomic markers. (Correlative study)

OUTLINE: This is a multicenter study. Patients are randomized according to prior doxorubicin
treatment ( yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats
every 21 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.

- Arm II: Patients receive pixantrone dimaleate IV over 1 hour on days 1, 8, and 15.
Treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

Some patients undergo blood sample collection at baseline and periodically during study for
circulating tumor cells analysis by CellSearch System and mRNA isolation assays.

Patients complete quality-of-life questionnaires using the Linear Analogue Self Assessment
(LASA6) and the Patient-Reported Outcomes Version of the Common Terminology Criteria for
Adverse Events (PRO-CTCAE) at baseline and periodically during study.

After completion of study therapy, patients are followed up every 3-6 months for up to 5

Inclusion Criteria


- Histologically or cytologically confirmed adenocarcinoma of the breast

- Metastatic disease

- Must have been treated in neoadjuvant, adjuvant, or metastatic setting with
anthracycline and/or taxane

- Must have received 2-3 prior chemotherapy regimens

- Received ≤ 2 prior chemotherapy regimens in the metastatic setting if no prior
neoadjuvant or adjuvant chemotherapy

- Received ≥ 1 prior chemotherapy regimen in the metastatic setting if prior
neoadjuvant or adjuvant chemotherapy

- Measurable disease

- HER2-negative disease

- No active brain metastasis, including leptomeningeal involvement

- CNS metastasis controlled by prior surgery and/or radiotherapy allowed

- There must be ≥ 2 months of no symptoms or evidence of progression

- Patient must discontinue corticosteroid to control brain edema

- Hormone receptor status not specified


- Menopausal status not specified

- ECOG performance status 0-2

- Life expectancy > 3 months

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10.0 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 5 times ULN

- Serum creatinine ≤ 1.5 times ULN

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- LVEF ≥ 50% and EKG normal within the past 22 days

- No other prior stage III or IV invasive cancer within the past 3 years except
curatively treated nonmelanoma skin cancer

- No uncontrolled hypertension (BP > 160/90 mm Hg on ≥ 2 occasions)

- Patients on any stable new regimen or adjusted anti-hypertensive medications
allowed provided BP < 140/90 mmHg for ≥ 3 different observations in ≥ 14 days

- No clinically significant cardiovascular or cerebrovascular disease, including any
history of the following:

- Myocardial infarction

- Unstable angina pectoris

- NYHA class II-IV congestive heart failure

- Uncontrolled or clinically significant cardiac arrhythmia

- Controlled atrial fibrillation allowed

- No uncontrolled intercurrent illness including, but not limited to, any of the

- Ongoing or active infection

- Psychiatric illness and/or social situations that would limit compliance with
study requirements

- No co-morbid systemic illnesses or other severe concurrent disease that, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed drug

- No history of allergy or hypersensitivity to drug product excipients or agents
chemically similar to pixantrone dimaleate


- See Disease Characteristics

- No more than 3 prior chemotherapy regimens for breast cancer

- This number includes neoadjuvant or adjuvant chemotherapy, if given

- If neoadjuvant or adjuvant chemotherapy has been giving it counts as 1 regimen

- Unlimited prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting

- Lifetime cumulative treatment with doxorubicin ≤ 400 mg/m²

- More than 3 weeks since prior major surgery, chemotherapy, or immunologic therapy

- At least 4 weeks since prior bevacizumab

- No prior radiotherapy within the past 4 weeks and recovered

- Radiotherapy to non-target lesions allowed

- Prior radiotherapy to a target lesion allowed provided there has been clear
progression of the lesion since completion of radiotherapy

- Palliative single dose of radiotherapy allowed

- No other concurrent chemotherapy, biologic agents, or radiotherapy

- No concurrent investigational procedures or investigational therapies

- Trials related to symptom management that do not employ hormonal treatments or
treatments that may block the path of the targeted agents used in this trial may
be allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of confirmed tumor responses (complete or partial response)

Safety Issue:


Principal Investigator

Kostandinos Sideras, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

May 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • HER2-negative breast cancer
  • male breast cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms



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Hutchinson Area Health Care Hutchinson, Minnesota  55350
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
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Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
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Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
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Cancer Research Center of Hawaii Honolulu, Hawaii  96813
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Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
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Mary Rutan Hospital Bellefontaine, Ohio  43311
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Grant Medical Center Cancer Care Columbus, Ohio  43215
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Knox Community Hospital Mount Vernon, Ohio  43050
Fisher-Titus Medical Center Norwalk, Ohio  44857
Flower Hospital Cancer Center Sylvania, Ohio  43560
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Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
Adventist Medical Center Portland, Oregon  97216
Guthrie Cancer Center at Guthrie Clinic Sayre Sayre, Pennsylvania  18840
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Galesburg Clinic, PC Galesburg, Illinois  61401
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Hematology Oncology Associates, PC Albuquerque, New Mexico  87106
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Goldschmidt Cancer Center Jefferson City, Missouri  65109
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