Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/10/2018
Start Date:May 2010
End Date:November 15, 2014

Use our guide to learn which trials are right for you!

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

RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in
treating patients with HER2-negative metastatic breast cancer.

OBJECTIVES:

Primary

- To assess the proportion of confirmed tumor responses at each dose level of pixantrone

Secondary

- To describe the distribution of progression-free survival (PFS) times of patients
receiving pixantrone

- To assess the 6-month PFS rate in patients receiving each dose level of pixantrone

- To describe the overall survival distribution of patients receiving pixantrone

- To assess the adverse event profile of pixantrone in the treatment of patients with
metastatic breast cancer.

- To evaluate the quality of life and patient-reported symptoms of patients receiving the
study regimen

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
years.

Registration and Randomization - Inclusion Criteria

1. Women or men

2. ≥18 years of age

3. Histologically or cytologically confirmed adenocarcinoma of the breast and clinical
evidence of metastatic breast cancer.

4. Pre-treatment requirements:

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

4.2. Must have received 2-3 prior chemotherapy treatment regimens NOTE: If NO prior
(neo)adjuvant chemotherapy, patient must have received a minimum of 2 prior
chemotherapy regimens in the metastatic setting.

4.2.1 NOTE: If prior (neo)adjuvant chemotherapy HAS been given, patient must have
received at least 1 prior chemotherapy regimen in the metastatic setting.

4.3. Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic
setting.

Unlimited prior hormonal therapy is allowed.

5. Patients must have measurable disease as defined in the protocol.

6. Negative pregnancy test done ≤7 days prior to registration, for women of childbearing
potential only.

7. The following laboratory values obtained ≤15 days prior to registration.

7.1 Hemoglobin ≥10.0g/dL

7.2 ANC ≥1500/mm^3

7.3 Platelet count ≥100,000/mL

7.4 Total bilirubin ≤1.5 x ULN)

7.5 SGOT (AST) and SGPT (ALT) ≤5 x ULN

7.6 Serum creatinine ≤1.5 x ULN

8. LVEF ≥50% and EKG within institutional normal limits completed ≤22 days prior to
registration.

9. ECOG Performance Status (PS) of 0, 1 or 2.

10. Life expectancy >3 months

11. Ability to complete questionnaire(s) by themselves or with assistance.

12. Patient has provided written informed consent

13. Willingness to return to NCCTG enrolling institution for follow-up.

Registration and Randomization - Exclusion Criteria

1. Any of the following because this study involves an investigational agent whose
genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown.

1.1 Pregnant women

1.2 Nursing women

1.3 Men or women of childbearing potential who are unwilling to employ adequate
contraception (as determined by the treating physician)

2. Stage III or IV invasive cancer (other than breast cancer) in ≤3 years prior to
registration (with the exception of non-melanoma skin cancer).

3. HER2 positive breast cancer (3+ by IHC or FISH amplified) breast cancer by ASCO/CAP
guidelines

4. Has already received lifetime cumulative treatment with doxorubicin equivalent to >400
mg/m2.

5. >3 prior chemotherapy regimens for breast cancer.

5.1 NOTE: This number includes (neo)adjuvant chemotherapy, if given. If (neo)adjuvant
chemotherapy HAS been given it counts as one (1) regimen.

6. Major surgery, chemotherapy, or immunologic therapy ≤3 weeks prior to registration.

6.1 NOTE: If patient has received prior treatment with bevacizumab, treatment on this
trial should not begin until ≥4 weeks after the last dose of bevacizumab.

7. Radiotherapy ≤4 weeks prior to registration, except if to a non-target lesion only.

7.1 Prior radiation to a target lesion is permitted only if there has been clear
progression of the lesion since radiation was completed.

7.2 If patient receives single dose radiation for palliation or radiation to
non-target lesion, they may immediately proceed to registration without waiting.

7.3 Acute adverse events from radiation must have resolved to ≤Grade 1 (according to
current version of NCI CTCAE).

8. Evidence of active brain metastasis including leptomeningeal involvement.

8.1 CNS metastasis controlled by prior surgery and/or radiotherapy is allowed. To be
considered controlled, there must be at least 2 months of no symptoms or evidence of
progression prior to study entry and corticosteroid therapy given to control brain
edema must have been discontinued.

9. Uncontrolled hypertension (blood pressure [BP] >160/90mmHg on ≥2 occasions at least 5
minutes apart). (Patients who have recently started or adjusted anti-hypertensive
medications are eligible providing that BP is <140/90mmHg on any new regimen for ≥3
different observations in ≥14 days.).

10. Clinically significant cardiovascular or cerebrovascular disease, including any
history of the following at any time prior to registration:

10.1 Myocardial infarction

10.2 Unstable angina pectoris

10.3 New York Heart Association (NYHA) Class II or greater congestive heart failure

10.4. Uncontrolled or clinically significant cardiac arrhythmia (patients with
controlled atrial fibrillation are eligible)

11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements.

12. Co-morbid systemic illnesses or other severe concurrent disease which, 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 regimens.

13. History of allergy or hypersensitivity to drug product excipients or agents chemically
similar to pixantrone.

14. Currently receiving treatment in a different clinical study in which investigational
procedures are performed or investigational therapies are administered.

14.1 Patient may not enroll in such clinical trials while participating in this study.

Exception may be granted for trials related to symptom management (Cancer Control) which do
not employ hormonal treatments or treatments that may block the path of the targeted agents
used in this trial.
We found this trial at
232
sites
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1201 Camino de Salud Northeast
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(505) 272-4946
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3535 Olentangy River Road
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(614) 566-5000
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
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701 Ilalo Street Suite 600
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808-586-3010
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98-1079 Moanalua Road
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777 Kimole Ln
Adrian, Michigan 49221
517-265-0900
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Albuquerque, New Mexico 87102
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Ames, Iowa 50010
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Anderson, South Carolina 29621
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5301 East Huron River Drive
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1.877.590.5995
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400 S Clark St
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6501 E 2nd St
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(307) 235-5433
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701 10th St SE
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525 10th St SE
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(319) 363-8303
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
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12495 University Ave
Clive, Iowa 50325
(515) 358-9700
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111 S Grant Avenue
Columbus, Ohio 43215
(614) 566-4321
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Columbus, Ohio 43228
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793 West State Street
Columbus, Ohio 43222
614-234-5000
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
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11850 Blackfoot St. NW Suite 130
Coon Rapids, Minnesota 55433
763-236-0808
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1 Wyoming St
Dayton, Ohio 45409
(937) 208-2300
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Dayton, Ohio 45406
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Dayton, Ohio 45420
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9000 North Main Street
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(937) 734-5800
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405 W Grand Ave
Dayton, Ohio 45405
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18101 Oakwood Blvd
Dearborn, Michigan 48124
(313) 593-8620
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561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
(515) 282-2921
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411 Laurel St New Visions
Des Moines, Iowa 50314
(515) 247-3970
Medical Oncology and Hematology Associates at Mercy Cancer Center When it comes to cancer care,...
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
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Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
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1221 Pleasant St
Des Moines, Iowa 50309
(515) 241-4141
John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
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411 Laurel Street
Des Moines, Iowa 50314
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Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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Duluth, Minnesota 55805
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502 E 2nd St,
Duluth, Minnesota 55805
(218) 727-8762
Miller - Dwan Medical Center Essentia Health-Duluth, located in the Miller-Dwan building, is a 165-bed...
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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600 East Blvd
Elkhart, Indiana 46515
(574) 294-2621
Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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303 S Nappanee St
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(574) 296-3200
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500 Arcade Blvd, Ste 240
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41201 Schadden Rd
Elyria, Ohio 44035
(440) 324-0480
Community Cancer Center When you have cancer, you might think first of treatments
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6282 Linton Blvd
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(561) 495-8307
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Escanaba, Michigan 49431
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101 S Major St
Eureka, Illinois 61530
(309) 467-2371
Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
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101 S Major St
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820 4th Street North
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801 Broadway N
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200 West Pearl Street
Findlay, Ohio 45840
419-424-0380
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302 Kensington Ave
Flint, Michigan 48503
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Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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2315 E Harmony Rd #110
Fort Collins, Colorado 80528
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Fort Collins, Colorado 80524
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Fredericksburg, Virginia 22401
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550 Osborne Road
Fridley, Minnesota 55432
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Great Falls, Montana 59405
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Great Falls, Montana 59405
406.455.5000
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835 Sweitzer St
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(937) 548-1141
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Hartford, Connecticut 06105
(860) 714-4000
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520 E. Franklin
Havana, Illinois 62644
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30 13th St
Havre, Montana 59501
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1301 Punchbowl Street
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Cancer Institute at Queen's Medical Center The Queen
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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1329 Lusitana St. Ste 307
Honolulu, Hawaii 96813
808.524.6115
OnCare Hawaii, Incorporated - Lusitana OnCare Hawaii is a Certified PROVENGE® Treatment Center. PROVENGE (sipuleucel-T)...
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2226 Liliha St
Honolulu, Hawaii 96817
(808) 547-6011
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Honolulu, Hawaii 96817
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