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
502 E 2nd St,
Duluth, Minnesota 55805
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Miller - Dwan Medical Center Essentia Health-Duluth, located in the Miller-Dwan building, is a 165-bed...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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3535 Olentangy River Road
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
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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
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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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 87106
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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
Ann Arbor, Michigan 48106
1.877.590.5995
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5301 McAuley Drive
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734-712-4673
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8111 South Emerson Avenue
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(317) 528-5000
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1101 N 27th St # 201
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(406) 237-3585
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2900 12th Ave N Ste 160W
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(406) 238-6290
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201 E Nicollet Blvd
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(952) 892-2000
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400 S Clark St
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1454 North County Road 2050
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(217) 357-8500
Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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6501 E 2nd St
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(307) 235-5433
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701 10th St SE
Cedar Rapids, Iowa 52403
(319) 365-4673
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525 10th St SE
Cedar Rapids, Iowa 52403
(319) 363-8303
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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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
Mercy Cancer Center - West Lakes When it comes to cancer care, there
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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
Mount Carmel Health - West Hospital Located near downtown Columbus, Mount Carmel West is the...
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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
Dayton, Ohio 45415
(937) 734-5800
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405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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18101 Oakwood Blvd
Dearborn, Michigan 48124
(313) 593-8620
Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
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561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
(515) 282-2921
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
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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
(515) 282-2921
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
(515) 247-3121
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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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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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
Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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500 Arcade Blvd, Ste 240
Elkhart, Indiana 46514
574-389-0414
Michiana Hematology-Oncology The Advanced Center for Cancer Care in Plymouth is part of the Cancer...
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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
Elyria, Ohio 44035
(561) 495-8307
Hematology Oncology Center The Center for Hematology-Oncology was established in 1995 for the purpose of...
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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
Eureka, Illinois 61530
309-467-2371
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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820 4th Street North
Fargo, North Dakota 58122
(701) 234-6292
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801 Broadway N
Fargo, North Dakota 58102
(701) 234-2000
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200 West Pearl Street
Findlay, Ohio 45840
419-424-0380
Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
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
(970) 212-7600
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Fort Collins, Colorado 80524
(970) 495-7000
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Franklin, Ohio 45005
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Fredericksburg, Virginia 22401
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550 Osborne Road
Fridley, Minnesota 55432
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1117 29th St S Ste 500
Great Falls, Montana 59405
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Great Falls, Montana 59405
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1101 26th Street South
Great Falls, Montana 59405
406.455.5000
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Greenville, Ohio 45331
(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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615 N. Promenade Street
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(309) 543-4431
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30 13th St
Havre, Montana 59501
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(406) 442-2480
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1301 Punchbowl Street
Honolulu, Hawaii 96813
(808) 538-9011
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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, HI
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Honolulu, Hawaii 96817
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Honolulu, HI
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Huntington, WV
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